E45 Cream (Forum Health Products Limited )


1. Name Of The Medicinal Product

E45 Cream

2. Qualitative And Quantitative Composition

Anhydrous Lanolin

 

1.0%

w/w

White Soft Paraffin

BP

14.5%

w/w

Light Liquid Paraffin

PhEur

12.6%

w/w

3. Pharmaceutical Form

A cream

4. Clinical Particulars 4.1 Therapeutic Indications

For the symptomatic relief of dry skin conditions, where the use of an emollient is indicated, such as flaking, chapped skin, ichthyosis, traumatic dermatitis, sunburn, the dry stage of eczema and certain dry cases of psoriasis.

4.2 Posology And Method Of Administration

For topical application.

Adults, Children, Babies and the Elderly - Apply to the affected part two or three times daily.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

The labelling states:

For external use only.

If symptoms persist, consult your doctor.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant interactions known.

4.6 Pregnancy And Lactation

The safety of E45 Cream in pregnancy and lactation has not been assessed but is thought unlikely to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Occasionally, hypersensitivity reactions, otherwise adverse effects are unlikely, but should they occur, may take the form of an allergic rash. Should this occur, use of the product should be discontinued.

4.9 Overdose

E45 cream is of low toxicity. If accidental ingestion occurs, conservative treatment only is required.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Lanolin, light liquid paraffin and white soft paraffin have emollient moisturising properties.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no pre-clinical safety data of relevance to the consumer.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Empilan GMS, cetyl alcohol, sodium cetostearyl sulphate, carbomer, methyl hydroxybenzoate, propyl hydroxybenzoate, sodium hydroxide, citric acid monohydrate, purified water.

6.2 Incompatibilities

Compatibility problems may be encountered with the stronger acids, calcium, magnesium and aluminium salts, quaternary compounds, acridines, basic dyestuffs and alkaloids.

6.3 Shelf Life

Aluminium tubes and polypropylene tubs: 3 years.

All other containers: 2 years.

6.4 Special Precautions For Storage

Store below 25°C for polyethylene tubes and pump pack, made of polypropylene and polyethylene and consisting of a plastic bottle and a pump system with a dip tube. None for aluminium tubes and polypropylene tubs.

6.5 Nature And Contents Of Container

A collapsible aluminium tube, internally lacquered with a membrane seal and plastic screw cap. Pack sizes: 15, 50 or 100 g.

(The 100 g tube is for dispensing only. One hundred tubes will be packed in an outer carton, labelled with the same wording as an OTC pack and the additional statement 'For dispensing only - not for retail sale'.)

A polyethylene tube with membrane seal and plastic screw cap. Pack sizes 15 or 50 g.

A polypropylene securipot with a white polythene pilfer-proof screw cap. Pack sizes: 125, 350 or 500 g.

A white polypropylene jar with a white polyethylene push-on, tamper-evident closure. Pack sizes: 250, 300 or 500 g.

((The 500 g jar is for dispensing only. Thirty-six jars will be packed in an outer carton, labelled with the same wording as an OTC pack and the additional statement 'For dispensing only - not for retail sale'.)

A polypropylene securipot with a polythene pilfer-proof screw cap fitted with a HDPE or polypropylene dispenser having a polythene covered follower plate.

Pack sizes: 500 or 900 g.

A pump pack made of polypropylene and polyethylene, consisting of a plastic bottle and a pump system with a dip tube. Pack size: 500 g.

A pump pack made of polypropylene and polyethylene, consisting of a piston pump system with an airless dispenser. Pack size: 500g

Not all pack sizes are necessarily marketed.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited

Wellcroft Road

Slough,

SL1 4AQ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00063/0404

9. Date Of First Authorisation/Renewal Of The Authorisation

25th September 1991

10. Date Of Revision Of The Text

07/10/2011

11 DOSIMETRY

IF APPLICABLE

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

IF APPLICABLE


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H. pylori eradication agents


A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Agents used in treatment of Helicobacter Pylori are medicines used for stomach acid inhibition, combined with antibacterial agents. Treatment is for one week with a proton pump inhibitor or an antacid (or antisecretory agents), and two appropriate antibacterial agents. This one week triple therapy does give a good eradication rate.

See also

Medical conditions associated with H. pylori eradication agents:

Helicobacter Pylori Infection Drug List: Prevpac-Therapy-Pack Pylera Helidac-Therapy-Pack
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Allergy Relief Tablets


loratadine
Dosage Form: tablet
Drug Facts Active ingredient

loratadine 10mg

Purpose

antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose • itchy, watery eyes • sneezing • itching of the nose or throat

Warnings Adverse Reactions Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask Doctor

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

When Using

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Pregnancy or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

Keep out of reach of children.

Overdose

In case of overdose, get medical help or contact a Poison Control Center right away.

Other Information safety sealed: do not use if the imprinted bottle seal with “sealed for your protection” is open or torn (for bottle carton only) safety sealed: do not use if the imprinted blister unit is open or torn (for blister carton only) store at 20-25°C (68-77°F) (see USP Controlled Room Temperature) Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Inactive ingredients

lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions

call 1-800-452-0051

 

 Distributed by Target Corp.

Minneapolis, MN 55403

copyright 2009 Target Brands, Inc.

All Rights Persevered

Principal Display

Target


ALLERGY RELIEF MEDICATION 
loratadine  tablet Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-315 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE   LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   SODIUM STARCH GLYCOLATE TYPE A POTATO   Product Characteristics Color WHITE Score no score Shape ROUND Size 6mm Flavor Imprint Code GG;296 Contains          Packaging # NDC Package Description Multilevel Packaging 1 11673-315-10 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 5 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11673-315-10) 2 11673-315-40 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11673-315-40) 3 11673-315-18 1 BOTTLE In 1 CARTON contains a BOTTLE 3 180 TABLET In 1 BOTTLE This package is contained within the CARTON (11673-315-18) 4 11673-315-60 6 BLISTER PACK In 1 CARTON contains a BLISTER PACK 4 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11673-315-60) 5 11673-315-30 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 5 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11673-315-30) 6 11673-315-15 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 6 5 TABLET In 1 BLISTER PACK This package is contained within the CARTON (11673-315-15)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA075209 01/31/2010
Labeler - Target Brands, Inc. (006961700) Revised: 09/2010Target Brands, Inc. More Allergy Relief Tablets resources Allergy Relief Tablets Side Effects (in more detail) Allergy Relief Tablets Dosage Allergy Relief Tablets Use in Pregnancy & Breastfeeding Allergy Relief Tablets Drug Interactions 0 Reviews for Allergy Reliefs - Add your own review/rating Compare Allergy Relief Tablets with other medications Hay Fever Urticaria
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Sensodyne Original / Sensodyne Toothpaste: Original Flavour 10% w / w


1. Name Of The Medicinal Product

Sensodyne Original / Sensodyne Toothpaste: Original Flavour 10% w/w

2. Qualitative And Quantitative Composition

Strontium chloride hexahydrate, 10% w/w

3. Pharmaceutical Form

Toothpaste

4. Clinical Particulars 4.1 Therapeutic Indications

Relief from the pain of dentine sensitivity

4.2 Posology And Method Of Administration

To be used 2-4 times daily, in place of ordinary toothpaste

4.3 Contraindications

None

4.4 Special Warnings And Precautions For Use

Sensitive teeth may indicate an underlying problem which needs prompt care by a dentist.

Dental advice should be sought as soon as possible after the problem develops.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

No adverse effects known

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

None known

4.9 Overdose

No symptoms of Sensodyne overdose are known.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Dentine sensitivity results from exposure of dentinal tubules to external stimuli. The hydrodynamic theory proposes that fluid movement within tubules stimulates mechanoreceptors in or near the pulp, causing pain. It is postulated that Sensodyne Original relieves pain by reducing fluid movement by occlusion of the tubules.

5.2 Pharmacokinetic Properties

Sensodyne Original is applied topically and so the pharmacokinetics of strontium chloride hexahydrate are not relevant to its efficacy.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Purified water

Glycerol

Sorbitol liquid (non-crystallising)

Calcium carbonate

Hydroxyethyl cellulose

Silica, colloidal anhydrous

Sodium methyl cocoyl taurate

Polyoxyl 40 stearate

Titanium dioxide

Sodium saccharin

F, D & C Red No.3 (E127, Erythrosine)

Flavour

Flavour mix constituents:

Spearmint oil

Peppermint oil

Levomenthol

Methyl salicylate

Oil of cassia

6.2 Incompatibilities

None known

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 25°C

6.5 Nature And Contents Of Container

Sensodyne Original will be packaged in the following containers and pack sizes.

Container Pack size (ml) Plastic laminate tube with full diameter cap and tamper evident nozzle seal 45, 50, 75, 100 Aluminium Barrier Laminate tube with full diameter cap 45, 50, 75, 100 Cross promotional pack containing plastic laminate tube and Sensodyne 75 6.6 Special Precautions For Disposal And Other Handling

Not appropriate

Administration Data 7. Marketing Authorisation Holder

Stafford Miller Limited

980 Great West Road

Brentford

Middlesex TW8 9GS

UNITED KINGDOM

Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, UK

8. Marketing Authorisation Number(S)

PL 0036/5011R

9. Date Of First Authorisation/Renewal Of The Authorisation

23 April 1991

10. Date Of Revision Of The Text

27 March 2009


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Boots Bite & Sting Relief 2 Years Plus Antihistamine Cream


Boots Bite & Sting Relief 2 Years Plus Antihistamine Cream

(Mepyramine Maleate)

From 2 years

Relieves pain, itching and swelling

20 g e

Read all of this carton for full instructions.

What this medicine is for

A soothing antihistamine cream for the relief of pain, itching and swelling caused by insect bites and stings, and nettle stings.

Before you use this medicine X Do not use: If you are allergic to any of the ingredients or other antihistamines If you have eczema or other skin conditions If you are pregnant or breastfeeding, unless your doctor tells you to On broken skin, sunburnt skin or on large areas of skin

Cetostearyl alcohol and lanolin may cause skin reactions (e.g. contact dermatitis).

How to use this medicine

Check the tube seal is not broken before first use. If it is, do not use the cream. Pierce tube seal with end of cap.

Apply to the skin only.

Adults and children of 2 years and over:

Smooth a very small amount on the affected area. Use the cream 2 or 3 times a day, for a maximum of 3 days.

Do not use on children under 2 years.

If a rash develops, or the condition gets worse, stop using the cream.

If symptoms do not go away talk to your doctor.

! If anyone accidentally swallows some:

Talk to a doctor straight away.

Possible side effects

Most people will not have problems.

If you get these side effects stop using the cream and see a doctor.

Allergic reaction (e.g. skin rash, red or itchy skin, worsening of the condition you are treating)

If you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredient

This cream contains Mepyramine Maleate 2% w/w.

Also contains: purified water, cetostearyl alcohol, white soft paraffin, liquid paraffin, cetomacrogol 1000, anhydrous hypoallergenic lanolin, sorbitan sesquioleate, sodium citrate, citric acid monohydrate.

PL 00014/0440

Text prepared 2/07

Manufactured by the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA

If you need more advice ask your pharmacist.

BTC14991 vD 15-06-07


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Monistat 7 Combination Pack


miconazole nitrate
Dosage Form: cream
Monistat 7 Combination Pack Triple Action

Drug Facts

Active ingredients Purpose Miconazole nitrate 2% (100 mg in each applicatorful) Vaginal antifungal Miconazole nitrate 2% (external cream) Vaginal antifungal Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection Warnings

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS

Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

When using this product

do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if

symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions before using this product, read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after use. external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days, as needed. children under 12 years of age: ask a doctor Other information

do not use if seal over tube opening has been punctured or embossed design

do not purchase if carton is open store at 20°-25°C (68°-77°F) Inactive ingredients benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol Questions?

If you have any questions or comments, please call 1-877-666-4782

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC-30014-003-07

MONISTAT®7
COMBINATION PACK
Miconazole Nitrate Cream (2%) and Miconazole Nitrate Cream (2%)

(Miconazole Nitrate 100 mg per applicator)

ORTHO
CLINICALLY PROVEN
Multi-Symptom Relief

VAGINAL ANTIFUNGAL

CURES MOST VAGINAL YEAST INFECTIONS AND
RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

7-Day Vaginal Cream with Disposable Applicators
PLUS External Cream

Net Wt. 1.59 oz. (45g)
+ 0.32 oz. (9g) Tube


Monistat 7 Combination Pack  TRIPLE ACTION
miconazole nitrate  kit Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 30014-003 Packaging # NDC Package Description Multilevel Packaging 1 30014-003-07 1 KIT In 1 PACKAGE, COMBINATION None QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 TUBE, WITH APPLICATOR   0.1 g Part 2 1 TUBE   0.009 g Part 1 of 2 MICONAZOLE NITRATE 
miconazole nitrate  cream Product Information       Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (Miconazole) Miconazole Nitrate 20 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0.1 g In 1 TUBE, WITH APPLICATOR None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/10/2010
Part 2 of 2 MICONASOLE NITRATE 
miconazole nitrate  cream Product Information       Route of Administration VAGINAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (Miconazole) Miconazole Nitrate 20 mg  in 1 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0.009 g In 1 TUBE None Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/10/2010
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017450 04/10/2010
Labeler - McNeil, PPC, Inc. (801375143) Revised: 04/2010McNeil, PPC, Inc.
More Monistat 7 Combination Pack resources Monistat 7 Combination Pack Side Effects (in more detail) Monistat 7 Combination Pack Use in Pregnancy & Breastfeeding Monistat 7 Combination Pack Drug Interactions Monistat 7 Combination Pack Support Group 0 Reviews for Monistat 7 Combination Pack - Add your own review/rating Compare Monistat 7 Combination Pack with other medications Vaginal Yeast Infection
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Boots Antifungal Cream


Boots Antifungal Cream

(Clotrimazole)

for fungal infections of the skin

20 g

Read all of this carton for full instructions.

What this medicine is for

An antifungal cream for the treatment of fungal skin infections including ringworm, athlete’s foot, fungal nappy rash, infections of the armpit, groin, toes and skin folds and thrush of the vulva or penis.

Before you use this medicine Do not use: If you are allergic to any of the ingredients If you are pregnant or breastfeeding, unless your doctor or midwife tells you to

Information about some of the ingredients: The ingredients in the cream may affect the latex used in contraceptives such as condoms and diaphragms. This may reduce the effectiveness of the contraceptives. You should therefore use other methods of contraception for at least 5 days after using this medicine in the genital area. You may, for example, use a spermicide gel in addition to the condom or diaphragm. If you need more advice about this speak to your pharmacist.

Cetyl alcohol and stearyl alcohol in this medicine may cause skin reactions (e.g. contact dermatitis).

How to use this medicine

Check the tube seal is not broken before first use. If it is, do not use the cream.

Pierce tube seal with end of cap.

Adults and children: Apply to the affected area two or three times a day. Use the cream for at least 2 weeks. In some cases it may be necessary to continue to use the cream for more than 4 weeks.

If you are using the cream for a foot infection, make sure your feet, especially between the toes, are washed and thoroughly dried before applying the cream. Apply to the skin only.

Do not use more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If anyone accidentally swallows some: Talk to a doctor straight away.

Possible side effects

Most people will not have problems, but some may get some.

If you get these side effects, stop using the cream and see a doctor: Allergic reaction (e.g. skin rash, red or itchy skin) These other effects are less serious. If they bother you talk to a pharmacist: Rarely, mild burning or irritation immediately after using the cream Pain

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton.

Active ingredient

This topical cream contains Clotrimazole 1% w/w.

Also contains: purified water, 2-octyldodecanol, stearyl alcohol, cetyl alcohol, cetyl esters wax, sorbitan stearate, polysorbate 60, benzyl alcohol.

PL 10622/0004 [P]

Text prepared 8/08

Manufactured for The Boots Company PLC Nottingham NG2 3AA

by

Thornton & Ross Ltd Linthwaite Huddersfield West Yorkshire HD7 5QH Marketing Authorisation held by PLIVA Pharma Ltd Vision House Bedford Road Petersfield Hampshire GU32 2QB

If you need more advice ask your pharmacist.

1498cXPil


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Sentry HC Worm X



Dosage Form: FOR ANIMAL USE ONLY
Broad Spectrum De-Wormer Chewable Tablets for Large Dogs INDICATIONS & USAGE

For Removal of Hookworms in Puppies and Dogs

Ancylostoma caninum Uncinaria stenocephala For Removal of Large Roundworms (Ascarids) in Puppies and Dogs
Toxocara canis Toxascaris leonina To Prevent Reinfection of Large Roundworms in Puppies, Adult Dogs and Lactating Bitches After Whelping
Toxocara canis ACTIVE INGREDIENT (in each chewable) Pyrantel Pamoate (113.5 mg) How is Sentry HC Worm X Supplied Net Contents:    2 Tablet Count
Net Contents:    4 Tablet Count
Net Contents:  12 Tablet Count STORAGE Store at controlled room temperature of 59-86 degrees F (15-30 degrees C). PACKAGE LABEL PRINCIPAL DISPLAY PANEL Sentry HC Worm X
Distributed by:
Sergeant's Pet Care Products, Inc., Omaha NE 68130
www.sentrypetcare.com
ANADA #200-281, Approved by FDA
Sentry HC Worm X 
pyrantel pamoate  tablet, chewable Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 21091-402 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRANTEL PAMOATE (PYRANTEL) PYRANTEL PAMOATE 113.5 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color brown Score no score Shape ROUND Size 10mm Flavor LIVER (Pork Liver Powder) Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 21091-402-02 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 2 TABLET In 1 BLISTER PACK This package is contained within the CARTON (21091-402-02) 2 21091-402-04 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 4 TABLET In 1 BLISTER PACK This package is contained within the CARTON (21091-402-04) 3 21091-402-12 6 BLISTER PACK In 1 CARTON contains a BLISTER PACK 3 12 TABLET In 1 BLISTER PACK This package is contained within the CARTON (21091-402-12)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200281 01/16/2008
Labeler - Sergeant's Pet Care Products, Inc. (876995171) Establishment Name Address ID/FEI Operations Virbac Bridgeton 808558100 manufacture Revised: 11/2010Sergeant's Pet Care Products, Inc.

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Mucinex DM


guaifenesin and dextromethorphan hydrobromide
Dosage Form: tablet, extended release
Mucinex®DM

600 mg guaifenesin & 30 mg dextromethorphan HBr extended-release bi-layer tablets

EXPECTORANT & COUGH SUPPRESSANT

Drug Facts

Active ingredients (in each extended-release bi-layer tablet) Purpose Dextromethorphan HBr 30 mg Cough suppressant Guaifenesin 600 mg Expectorant Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep Warnings

Do not use

for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)

When using this product

do not use more than directed

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours children under 12 years of age: do not use Other information tamper evident: do not use if carton is open or if printed seal on blister is broken or missing store at 20-25°C (68-77°F) Inactive ingredients

carbomer 934P, NF; D&C yellow #10 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Distributed by:
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
©RBI 2009

PRINCIPAL DISPLAY PANEL - 600 mg Carton

NDC 63824-056-32

Mucinex®DM

600 mg guaifenesin & 30 mg dextromethorphan HBr
extended-release bi-layer tablets

EXPECTORANT & COUGH SUPPRESSANT

12 HOUR

NEW LOOK-
SAME RELIEF

Thins And Loosens Mucus

Controls Cough

20 EXTENDED-RELEASE BI-LAYER TABLETS


Mucinex DM 
guaifenesin and dextromethorphan hydrobromide  tablet, extended release Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 63824-056 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (Guaifenesin) Guaifenesin 600 mg Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 30 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE (yellow and white) Score no score Shape OVAL Size 16mm Flavor Imprint Code Mucinex;600 Contains          Packaging # NDC Package Description Multilevel Packaging 1 63824-056-32 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (63824-056-32) 2 63824-056-34 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (63824-056-34) 3 63824-056-58 1 BOTTLE In 1 CARTON contains a BOTTLE 3 58 TABLET In 1 BOTTLE This package is contained within the CARTON (63824-056-58) 4 63824-056-72 25 POUCH In 1 CARTON contains a POUCH 4 2 TABLET In 1 POUCH This package is contained within the CARTON (63824-056-72) 5 63824-056-76 3 POUCH In 1 CARTON contains a POUCH 5 2 TABLET In 1 POUCH This package is contained within the CARTON (63824-056-76)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021620 03/31/2009
Labeler - Reckitt Benckiser, Inc. (094405024) Revised: 12/2009Reckitt Benckiser, Inc.
More Mucinex DM resources Mucinex DM Side Effects (in more detail) Mucinex DM Dosage Mucinex DM Use in Pregnancy & Breastfeeding Mucinex DM Drug Interactions Mucinex DM Support Group 0 Reviews for Mucinex DM - Add your own review/rating Mucinex DM Concise Consumer Information (Cerner Multum) Anti-Tuss DM Concise Consumer Information (Cerner Multum) Atuss-12 DX Extended-Release Liquid MedFacts Consumer Leaflet (Wolters Kluwer) Bidex-A Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Duratuss DM 12 Suspension MedFacts Consumer Leaflet (Wolters Kluwer) Guaifenesin DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer) Humibid CS MedFacts Consumer Leaflet (Wolters Kluwer) Robitussin DM infant drops Scot-Tussin DM Liquid MedFacts Consumer Leaflet (Wolters Kluwer) Compare Mucinex DM with other medications Cough Expectoration
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Mucinex DM Maximum Strength


guaifenesin and dextromethorphan hydrobromide
Dosage Form: tablet, extended release
Mucinex®DM

Drug Facts

Active ingredients (in each extended-release bi-layer tablet) Purpose Dextromethorphan HBr 60 mg Cough suppressant Guaifenesin 1200 mg Expectorant Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep Warnings

Do not use

for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)

When using this product

do not use more than directed

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age: do not use Other information tamper evident: do not use if carton is open or if printed seal on blister is broken or missing store at 20-25°C (68-77°F) Inactive ingredients

carbomer 934P, NF; D&C yellow #10 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Distributed by:
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
©RBI 2009

PRINCIPAL DISPLAY PANEL - 1200 mg Carton

MAXIMUM STRENGTH

NDC 63824-072-35

Mucinex®DM

1200 mg guaifenesin & 60 mg dextromethorphan HBr
extended-release bi-layer tablets

EXPECTORANT & COUGH SUPPRESSANT

12 HOUR

NEW LOOK-
SAME RELIEF

Thins And Loosens Mucus

Controls Cough

14 EXTENDED-RELEASE BI-LAYER TABLETS


MUCINEX DM  MAXIMUM STRENGTH
guaifenesin and dextromethorphan hydrobromide  tablet, extended release Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 63824-072 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (Guaifenesin) Guaifenesin 1200 mg Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 60 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE (yellow and white) Score no score Shape OVAL Size 22mm Flavor Imprint Code Mucinex;1200 Contains          Packaging # NDC Package Description Multilevel Packaging 1 63824-072-35 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 7 TABLET In 1 BLISTER PACK This package is contained within the CARTON (63824-072-35) 2 63824-072-36 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 7 TABLET In 1 BLISTER PACK This package is contained within the CARTON (63824-072-36) 3 63824-072-39 1 BOTTLE In 1 CARTON contains a BOTTLE 3 38 TABLET In 1 BOTTLE This package is contained within the CARTON (63824-072-39) 4 63824-072-45 1 BOTTLE In 1 CARTON contains a BOTTLE 4 44 TABLET In 1 BOTTLE This package is contained within the CARTON (63824-072-45)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021620 03/31/2009
Labeler - Reckitt Benckiser, Inc. (094405024) Revised: 12/2009Reckitt Benckiser, Inc.
More Mucinex DM Maximum Strength resources Mucinex DM Maximum Strength Side Effects (in more detail) Mucinex DM Maximum Strength Dosage Mucinex DM Maximum Strength Use in Pregnancy & Breastfeeding Mucinex DM Maximum Strength Drug Interactions Mucinex DM Maximum Strength Support Group 0 Reviews for Mucinex DM Maximum Strength - Add your own review/rating Allfen DM Concise Consumer Information (Cerner Multum) Anti-Tuss DM Concise Consumer Information (Cerner Multum) Atuss-12 DX Extended-Release Liquid MedFacts Consumer Leaflet (Wolters Kluwer) Bidex-A Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Duratuss DM 12 Suspension MedFacts Consumer Leaflet (Wolters Kluwer) Guaifenesin DM Elixir MedFacts Consumer Leaflet (Wolters Kluwer) Humibid CS MedFacts Consumer Leaflet (Wolters Kluwer) Robitussin DM infant drops Scot-Tussin DM Liquid MedFacts Consumer Leaflet (Wolters Kluwer) Compare Mucinex DM Maximum Strength with other medications Cough Expectoration
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Osteoarthritis Medications


Definition of Osteoarthritis: Osteoarthritis is a chronic disease causing deterioration of the joint cartilage (the softer parts of bones, which cushion their connections to each other) and the formation of new bone (bone spurs) at the margins of the joints.

Drugs associated with Osteoarthritis

The following drugs and medications are in some way related to, or used in the treatment of Osteoarthritis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Osteoarthritis

Medical Encyclopedia:

Osteoarthritis

Harvard Health Guide:

Symptoms and treatment for Osteoarthritis

Drugs.com Health Center:

Osteoarthritis
Drug List: A-G-Profen A-Methapred-Solution Aceta-W-Codeine Actiprofen Actron Addaprin Advil Advil-Liqui-Gels Aflaxen Aleve All-Day-Pain-Relief All-Day-Relief Amigesic Amino-Opti-C Anaprox Anaprox-Ds Ansaid Aristocort Aristocort-Forte Arthritis-Pain Arthritis-Pain-Formula Arthrotec Ascriptin Ascriptin-Maximum-Strength Aspercreme-Cream Aspergum-Gum Aspirin-Buffered Aspirin-Lite-Coat Aspiritab Axsain-Cream Bayer Bayer-Plus Bayer-Aspirin-With-Calcium Bextra Buffered-Aspirin Bufferin Bufferin-Arthritis-Strength Bufferin-Extra-Strength Capital-W-Codeine-Suspension Capital-With-Codeine-Suspension Capsicum-Oleoresin Capsin Capzasin-Liquid Capzasin-Back-And-Body Capzasin-Quick-Relief Capzasin-Hp Capzasin-Hp-Arthritis-Formula Capzasin-P-Cream Castiva-Warming-Lotion Cataflam Celebrex Celestone-Solution Celestone-Soluspan Choline-Magnesium-Trisalicylate Clinacort-Injection Clinalog-Injection Clinoril Cocet Cocet-Plus Comfort-Pac-With-Naproxen Cortone-Acetate Cosamin-Ds Cosmegen Cymbalta Daypro Deltasone Depo-Medrol-Suspension Disalcid Dolobid Dolorac Dr-S-Cream Duexis Easprin Ec-Naprosyn-Enteric-Coated-Tablets Ecotrin-Delayed-Release-Tablets Ecotrin-Adult-Low-Strength Ecotrin-Maximum-Strength Empirin Euflexxa Excedrin Excedrin-Extra-Strength Excedrin-Quick-Tab-Peppermint Excedrin-Tension-Headache Ez-Iii Fasprin Feldene Genace Genacote Genpril Glucosamine-Chondroitin-With-Msm Gnp-Capsaicin-Lotion Goodys-Extra-Strength Halfprin Haltran Hyalgan Ibu Ibu-200 Icyhot-Pm-Medicated-Patch Indocin Indocin-Iv Indocin-Sr-Sustained-Release-Capsules Ken-Jec-40-Injection Kenalog-10-Suspension Kenalog-40-Suspension Leader-Naproxen-Sodium Limbrel Limbrel-250 Limbrel-500 Litecoat-Aspirin Lodine Lodine-Xl Medi-Seltzer-Effervescent-Tablets Medrol Medrol-Dosepak Menthac-Arthritis-Cream-With-Capsaicin Methylprednisolone-Dose-Pack Meticorten Midol-Extended-Relief Midol-Ib Mobic Motrin Motrin-Ib Myoflex-Cream Nalfon Naprelan-Sustained-Release-Tablets Naprosyn Norwich-Aspirin Nuprin Orthovisc Orudis Orudis-Kt Oruvail-Extended-Release-Capsules Osteo-Bi-Flex Osteo-Bi-Flex-Advanced Osteo-Bi-Flex-Double-Strength Osteo-Bi-Flex-Plus-Msm Osteo-Bi-Flex-Triple-Strength P-1000 Pan-C-500 Pennsaid Peridin-C Prevacid_Naprapac Prevacid-Naprapac-375 Prevacid-Naprapac-500 Pryflex Q-Profen Qutenza Relafen Relamine Rt-Capsin Rutin Salflex Salonpas-Gel-Patch Salonpas-Pain-Patch-With-Capsaicin Salsitab Same Schiff-Move-Free Schiff-Move-Free-Caplets Sloan-S-Liniment Solu-Medrol-Solution Span-C Stanback-Analgesic Sterapred Sterapred-Ds Supac Supartz Synvisc Synvisc-One Tac-3-Injection Tolectin Tolectin-600 Tolectin-Ds Tri-Buffered-Aspirin Triam-Forte Triamcot-Injection Triamonide-40-Injection Tricosal Trilisate Trixaicin Trixaicin-Hp Tylenol-W-Codeine Tylenol-With-Codeine-3 Tylenol-With-Codeine-4 U-Tri-Lone-Injection Valorin-Extra Vimovo Vioxx Voltaren Voltaren-Gel Voltaren-Xr-Extended-Release-Tablets Vopac Ysp-Aspirin Zorprin-Controlled-Release-Tablets Zostrix-Cream Zostrix-Diabetic-Foot-Pain Zostrix-Foot-Pain Zostrix-Neuropathy Zostrix-Sports Zostrix-Hp
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Radian B Muscle Lotion


1. Name Of The Medicinal Product

Radian B Liniment/Radian B Muscle Lotion/Radian B Sport Muscle Lotion/ Radian B Winter Sport Muscle Lotion/ Cura Heat Pain Relief Lotion

2. Qualitative And Quantitative Composition

Menthol

1.4

%w/v

Camphor

0.6

%w/v

Aspirin

1.2

%w/v

Equivalent to ammonium salicylate

1.0

%w/v

Methyl Salicylate

0.6

%w/v

Equivalent to salicylic acid

(as Methyl and Ethyl Esters)

0.54

%w/v

3. Pharmaceutical Form

Liniment for topical application to human beings.

4. Clinical Particulars 4.1 Therapeutic Indications

For symptomatic relief of muscular aches and pains, including fibrositis, sciatica, lumbago, sprained ligaments, bruises, muscle stiffness, strains, tennis elbow, golf shoulder.

4.2 Posology And Method Of Administration

Posology: For external application.

For Adults and Children Over 12 Years:

Apply the lotion on the affected part once or twice, leaving 10-15 minutes between applications. Smooth in or massage if preferred. If necessary, repeat application up to three times daily, reducing to morning and evening when acute symptoms subside.

When convenient, use after a warm bath.

Children Under 12: Not recommended for children under 12.

Elderly: The adult dose is appropriate.

4.3 Contraindications

Not to be used on children under 12 years old. Do not apply to skin abrasions. Do not apply to irritated skin. Not to be used by persons who are sensitive to any of the ingredients. If irritation develops, use of the product should be discontinued. Pregnancy and lactation.

4.4 Special Warnings And Precautions For Use

Keep away from eyes and other sensitive areas. If symptoms persist, consult a doctor. Flammable: Do not use near naked flame. Should not be placed on or used near polished or painted surfaces.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

There have been reports that topical salicylates may potentiate the anticoagulant effects of warfarin.

4.6 Pregnancy And Lactation

Use of the product during pregnancy and lactation is not recommended.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

If used on tender skin do not cover immediately after application. If an adverse reaction occurs, discontinue use immediately. Known side effects of menthol - contact dermatitis or eczema, hypersensitivity reactions characterised by urticaria, flushing and headache.

4.9 Overdose

When used externally as directed, overdose is unlikely.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Radian B is manufactured using the following active ingredients; Menthol, camphor, aspirin and methyl salicylate. The finished product contains menthol, camphor, ammonium salicylate and a mixture of methyl and ethyl esters of salicylic acid. The product provides salicylate ions which have analgesic properties. Methyl and ethyl salicylate are readily absorbed through the skin and have counter-irritant properties. Menthol relieves itching, dilates the vessels causing a sensation of coldness followed by an analgesic effect. Camphor acts as a rubefacient and mild analgesic and is employed as a counter-irritant.

5.2 Pharmacokinetic Properties

The active ingredients are well-documented pharmacopoeial ingredients. The extent of percutaneous absorption in human volunteers of (14C) acetyl salicylic acid from Radian B was studied and estimated by measurement of blood and urinary concentrations of radioactivity. Significant absorption through the skin was indicated by the excretion of almost 10% of the applied radioactivity in the urine within 5 days with approximately 5.5% in the first 24 hours.

5.3 Preclinical Safety Data

None

6. Pharmaceutical Particulars 6.1 List Of Excipients

Industrial Methylated Spirit 95

Glycerol

Citronella oil

Ammonia '880'

Water (purified)

6.2 Incompatibilities

None known

6.3 Shelf Life

60 months

6.4 Special Precautions For Storage

Store below 25°C

6.5 Nature And Contents Of Container

Ribbed oval glass bottle with polypropylene insert and plastic cap. Polythene bottle and plastic cap. Pack sizes 50 and 100ml.

White HDPE bottle with red urea cap and wad. Pack sizes: 30, 125 and 250ml oval bottles and 500 and 2000ml round bottles.

Boston round silver HDPE bottle and silver polypropylene cap without wad. Pack size 500ml.

Silver HDPE bottle with silver coloured, black urea cap and wad and LDPE insert. Pack sizes: 125 and 250ml oval bottle.

Silver HDPE bottle with LDPE plug insert and warm red coloured, spigot seal polypropylene cap. Pack sizes: 125, 250ml and 500ml oval bottle.

White polypropylene bottle with an angled neck containing an applicator, consisting of polypropylene plug, ring and spring, encasing a red polyurethane foam, with a red polypropylene cap. Pack size 80ml.

6.6 Special Precautions For Disposal And Other Handling

No special precautions necessary

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0359

9. Date Of First Authorisation/Renewal Of The Authorisation

30 April 2002

10. Date Of Revision Of The Text

04/03/2008


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Loratadine Drug Facts


Dosage Form: tablet
Drug Facts Active Ingredient (in each tablet)

Loratadine, USP 10 mg

Purpose

Antihistamine

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose itchy, watery eyes sneezing itching of the nose or throat Warnings Do not use

if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have

liver or kidney disease.Your doctor should determine if you need a different dose.

When using this product

do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor

if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Other Information Safety sealed: do not use if the imprinted bottle seal is open or torn (for bottle only). Safety sealed: do not use if open or torn (for blister package only). Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Inactive Ingredients

Lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions or comments?

1-800-525-8747

05-2010M

Sandoz Inc.

Princeton, NJ 08540

mg Label

NDC 0781-5077-01 Non-Drowsy*

LORAtadine

Tablets, USP

10 mg

Antihistamine

Indoor & Outdoor Allergies

100 Tablets

SANDOZ

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery

Eyes

Itchy Throat

or Nose

* When taken as directed.

See Drug Facts Panel.


mg Blister Pack

NDC 0781-5077-64

LORAtadine Tablets, USP 10 mg

10-2009M


mg Blister Pack Carton

NDC 0781-5077-64

Non-Drowsy*

LORAtadine

Tablets, USP

10 mg Antihistamine

Indoor & Outdoor Allergies

30 Tablets

SANDOZ

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery

Eyes

Itchy Throat

or Nose


LORATADINE 
loratadine  tablet Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0781-5077 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   SODIUM STARCH GLYCOLATE TYPE A POTATO   Product Characteristics Color WHITE (white to off white) Score no score Shape ROUND Size 6mm Flavor Imprint Code GG296 Contains          Packaging # NDC Package Description Multilevel Packaging 1 0781-5077-76 12 CARTON In 1 CARTON contains a CARTON (0781-5077-64) 1 0781-5077-64 1 BLISTER PACK In 1 CARTON This package is contained within the CARTON (0781-5077-76) and contains a BLISTER PACK 1 30 TABLET In 1 BLISTER PACK This package is contained within a CARTON (0781-5077-64) and a CARTON (0781-5077-76) 2 0781-5077-01 100 TABLET In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075209 01/21/2003
Labeler - Sandoz Inc (110342024) Establishment Name Address ID/FEI Operations Sandoz Inc 110342024 MANUFACTURE Establishment Name Address ID/FEI Operations Thermo-Pak, Inc 161049044 PACK, LABEL Revised: 06/2010Sandoz Inc
More Loratadine Drug Facts resources Loratadine Drug Facts Side Effects (in more detail) Loratadine Drug Facts Dosage Loratadine Drug Facts Use in Pregnancy & Breastfeeding Drug Images Loratadine Drug Facts Drug Interactions Loratadine Drug Facts Support Group 21 Reviews for Loratadine Drug Facts - Add your own review/rating Compare Loratadine Drug Facts with other medications Hay Fever Urticaria
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Mucinex D Maximum Strength



Dosage Form: tablet, extended release
Mucinex®D

Drug Facts

Active ingredients (in each extended-release bi-layer tablet) Purpose Guaifenesin 1200 mg Expectorant Pseudoephedrine HCl 120 mg Nasal Decongestant Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure Warnings

Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus)

When using this product

do not use more than directed

Stop use and ask a doctor if

you get nervous, dizzy, or sleepless symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age: do not use Other information tamper evident: do not use if carton is open or if printed seal on blister is broken or missing store at 20-25°C (68-77°F) Inactive ingredients

carbomer 934P, NF; FD&C yellow #6 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Distributed by:
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
©RBI 2009

PRINCIPAL DISPLAY PANEL - 1200 mg Carton

MAXIMUM STRENGTH

NDC 63824-041-24

Mucinex®D

1200 mg guaifenesin & 120 mg pseudoephedrine HCl
extended-release bi-layer tablets

EXPECTORANT & NASAL DECONGESTANT

12 HOUR

NEW LOOK-
SAME RELIEF

Thins And Loosens Mucus

Clears Nasal/Sinus Congestion

24 EXTENDED-RELEASE BI-LAYER TABLETS


MUCINEX D   MAXIMUM STRENGTH
guaifenesin and pseudoephedrine hydrochloride  tablet, extended release Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 63824-041 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (Guaifenesin) Guaifenesin 1200 mg Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 120 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color ORANGE, WHITE Score no score Shape OVAL Size 22mm Flavor Imprint Code Mucinex;1200 Contains          Packaging # NDC Package Description Multilevel Packaging 1 63824-041-24 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 8 TABLET In 1 BLISTER PACK This package is contained within the CARTON  (63824-041-24)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021585 04/17/2009
Labeler - Reckitt Benckiser, Inc. (094405024) Revised: 12/2009Reckitt Benckiser, Inc.
More Mucinex D Maximum Strength resources Mucinex D Maximum Strength Side Effects (in more detail) Mucinex D Maximum Strength Use in Pregnancy & Breastfeeding Drug Images Mucinex D Maximum Strength Drug Interactions Mucinex D Maximum Strength Support Group 58 Reviews for Mucinex D Maximum Strength - Add your own review/rating Compare Mucinex D Maximum Strength with other medications Cough and Nasal Congestion
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Adrenogenital Syndrome Medications


Definition of Adrenogenital Syndrome: Congenital adrenal hyperplasia refers to a group of inherited disorders relating to the adrenal glands, characterized by a deficiency in the hormones cortisol and aldosterone and an overproduction of androgen. More...

Drugs associated with Adrenogenital Syndrome

The following drugs and medications are in some way related to, or used in the treatment of Adrenogenital Syndrome. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Adrenogenital Syndrome

Medical Encyclopedia:

Congenital adrenal hyperplasia
Drug List: A-Methapred-Solution Baycadron De-Sone-La-Injection Decadron Deltasone Depo-Medrol-Suspension Dexacen-4-Injection Dexacort-Phosphate-In-Turbinaire Dexamethasone-Intensol Dexasone-Injection Dexasone-La-Injection Dexpak-Tablets-Dose-Pack Florinef Florinef-Acetate Medrol Medrol-Dosepak Methylprednisolone-Dose-Pack Meticorten Solu-Medrol-Solution Solurex-Injection Solurex-La-Injection Sterapred Sterapred-Ds Zema-Pak-10-Day
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Gavilax


polyethylene glycol-3350
Dosage Form: powder, for solution
Gavilax (Polyethylene Glycol 3350, Powder for Oral Solution) DESCRIPTION

Drug Facts

Active Ingredient (in each dose)…………………     Purpose

Polyethylene Glycol 3350, 17 g (cap filled to line).......Laxative

Use

relieves occasional constipation (irregularity)

generally produces a bowel movement in 1 to 3 days

WARNINGS

Allergy alert: Do not use if you are allergic to polyethylene glycol

Do not use if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have

nausea, vomiting or abdominal pain

a sudden change in bowel habits that lasts over 2 weeks

irritable bowel syndrome

Ask a doctor or pharmacist before use if you are taking a prescription drug

When using this product you may have loose, watery, more frequent stools

Stop use and ask a doctor if

you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition.

you get diarrhea

you need to use a laxative for longer than 1 week

side effects occur.

Drug Facts (continued)

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a POISON CONTROL CENTER right away.

Directions

do not take more than directed unless advised by your doctor

the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line.

adults and children 17 years of age and older:

fill to top of line in cap which is marked to indicate the correct dose (17 g)

stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink

use once a day

use no more than 7 days

children 16 years of age or under: ask a doctor

Other Information

store at 20° - 25°C (68°– 77°F)

tamper-evident: do not use if printed foil seal under cap is missing, open or broken

Inactive Ingredients           none

Questions or comments?

1-866-403-7592

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Gavilax 
polyethylene glycol-3350  powder, for solution Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 43386-312 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYETHYLENE GLYCOL 3350 (POLYETHYLENE GLYCOL 3350) POLYETHYLENE GLYCOL 3350 17 g Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 43386-312-08 14 DOSE PACK In 1 BOTTLE None 2 43386-312-14 30 DOSE PACK In 1 BOTTLE None
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091077 10/09/2009
Labeler - GAVIS Pharmaceuticals, LLC (829838551) Contact Address Telephone Number Email Address Anu Radha Subramanian Address: 400 Campus Drive City, State, Zip: Somerset, NJ, 08873 Country: USA ++1908-603-6080 [email protected] Registrant - Novel Laboratories, Inc. (793518643) Establishment Name Address ID/FEI Operations Novel Laboratories, Inc. 793518643 manufacture, repack, MANUFACTURE, ANALYSIS, ANALYSIS Establishment Name Address ID/FEI Operations Dow Chemical Company 801038019 api manufacture, MANUFACTURE Revised: 10/2009GAVIS Pharmaceuticals, LLC
More Gavilax resources Gavilax Side Effects (in more detail) Gavilax Use in Pregnancy & Breastfeeding Gavilax Drug Interactions Gavilax Support Group 0 Reviews for Gavilax - Add your own review/rating GlycoLax Concise Consumer Information (Cerner Multum) GlycoLax Powder for Oral Solution MedFacts Consumer Leaflet (Wolters Kluwer) Compare Gavilax with other medications Bowel Preparation Constipation Constipation, Acute
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Monistat 1 Combo Pack Cream


Pronunciation: mi-KON-a-zole
Generic Name: Miconazole
Brand Name: Monistat 1 Combo Pack
Monistat 1 Combo Pack Cream is used for:

Treating vaginal yeast infections and relieving external vulvar itching and irritation associated with yeast infection.

Monistat 1 Combo Pack Cream is an antifungal agent. It works by weakening the cell membrane of the fungus, resulting in the death of the fungus.

Do NOT use Monistat 1 Combo Pack Cream if: you are allergic to any ingredient in Monistat 1 Combo Pack Cream you have never had a vaginal yeast infection diagnosed by a doctor

Contact your doctor or health care provider right away if any of these apply to you.

Before using Monistat 1 Combo Pack Cream:

Some medical conditions may interact with Monistat 1 Combo Pack Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have the blood disease porphyria or a history of liver disease, or you have been exposed to HIV if you have stomach, shoulder, or lower back pain; fever; chills; nausea; foul-smelling vaginal discharge; or vomiting if this is the first time you have had vaginal itching and discomfort if you have vaginal yeast infections often (eg, once a month or 3 in 6 months) if you are taking antibiotics

Some MEDICINES MAY INTERACT with Monistat 1 Combo Pack Cream. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) because the risk of side effects such as bruising or bleeding may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Monistat 1 Combo Pack Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Monistat 1 Combo Pack Cream:

Use Monistat 1 Combo Pack Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Monistat 1 Combo Pack Cream comes with an additional patient leaflet. Read it carefully and reread it each time you get Monistat 1 Combo Pack Cream refilled. Monistat 1 Combo Pack Cream is for vaginal use only. Do not use in the eyes or take by mouth. Suppositories - Using the applicator provided, insert the suppository high into the vagina at bedtime. External cream - Squeeze a small amount of cream onto your finger and gently spread the cream onto the itchy, irritated skin outside the vagina as directed by your doctor or on the packaging. Wash your hands immediately after using Monistat 1 Combo Pack Cream. To clear up your infection completely, continue using Monistat 1 Combo Pack Cream for the full course of treatment. If you miss a dose of Monistat 1 Combo Pack Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Monistat 1 Combo Pack Cream.

Important safety information: Monistat 1 Combo Pack Cream is for vaginal use only. Avoid contact with the eyes, nose, or mouth. If you get Monistat 1 Combo Pack Cream in your eyes, flush with a generous amount of cool water. It is important to use Monistat 1 Combo Pack Cream for the full course of treatment. Failure to do so may decrease the effectiveness of Monistat 1 Combo Pack Cream and increase the risk that the fungus will no longer be sensitive to Monistat 1 Combo Pack Cream and will not be able to be treated by this or certain other antibiotics in the future. If your symptoms do not improve within 3 days, if they last more than 7 days, or if they become worse, stop using Monistat 1 Combo Pack Cream and contact your health care provider at once. You may have a more serious illness. Do not use Monistat 1 Combo Pack Cream for itching caused by other conditions. Dry the outside vaginal area completely after showering, bathing, or swimming. Do not go swimming for at least 9 to 12 hours after applying Monistat 1 Combo Pack Cream. Change out of wet bathing suits or damp workout clothes as soon as possible. Continue using Monistat 1 Combo Pack Cream even during your menstrual period. Do not use tampons while you are using Monistat 1 Combo Pack Cream or until all of your symptoms go away. Use unscented pads or pantiliners. Do not have vaginal sexual intercourse while you are using Monistat 1 Combo Pack Cream. Monistat 1 Combo Pack Cream may decrease the effectiveness of condoms and diaphragms, increasing the chance of pregnancy or risk of sexually transmitted disease. Do not use these products for at least 1 day after treatment with Monistat 1 Combo Pack Cream. Do not use tampons, douches, spermicides, or other vaginal products while using Monistat 1 Combo Pack Cream. Overuse of topical products may worsen your condition. Do not use Monistat 1 Combo Pack Cream in CHILDREN younger than 12 years of age unless advised to do so by your health care provider. PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Monistat 1 Combo Pack Cream, discuss with your doctor the benefits and risks of using Monistat 1 Combo Pack Cream during pregnancy. It is unknown if Monistat 1 Combo Pack Cream is excreted in breast milk. If you are or will be breast-feeding while you are using Monistat 1 Combo Pack Cream, check with your doctor or pharmacist. Possible side effects of Monistat 1 Combo Pack Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; mild vaginal burning, irritation, or itching; stomach cramps.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever or chills; foul-smelling vaginal discharge; nausea; severe or prolonged vaginal burning, irritation, or itching; stomach pain; swelling; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Monistat Combo Pack side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Monistat 1 Combo Pack Cream:

Store Monistat 1 Combo Pack Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not use if the wrapper on the applicator or suppository is torn or damaged. Keep Monistat 1 Combo Pack Cream out of the reach of children and away from pets.

General information: If you have any questions about Monistat 1 Combo Pack Cream, please talk with your doctor, pharmacist, or other health care provider. Monistat 1 Combo Pack Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Monistat 1 Combo Pack Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Monistat 1 Combo Pack resources Monistat 1 Combo Pack Side Effects (in more detail) Monistat 1 Combo Pack Use in Pregnancy & Breastfeeding Monistat 1 Combo Pack Drug Interactions 0 Reviews for Monistat Combo Pack - Add your own review/rating Compare Monistat 1 Combo Pack with other medications Vaginal Yeast Infection
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Boots Soothing Eye Drops


Boots Soothing Eye Drops

(Cetrimide, Hamamelis Water)

Soothing & antiseptic

10 ml e

Read all of this carton for full instructions.

Uses: A soothing and antiseptic sterile solution for the relief of minor eye irritation. It can be used to soothe eyes irritated by smoke and dust. Before you use this medicine Do not use: If you are allergic to any of the ingredients If you wear soft contact lenses

You can use this medicine if you are pregnant or breastfeeding.

How to use this medicine

Check the cap seal is not broken before first use. If it is, do not use the drops.

Tilt head back and hold down lower eye lid. Squeeze the bottle to put drops into the corner (lower sac) of the eye.

For use in the eyes only.

Age: Adults and children How much: One or two drops How often: Morning and night, or when you need to

If anyone accidentally swallows some: Talk to a doctor

Possible side effects

Most people will not have problems, but some may get some of these:

Red, swollen or itchy eyes (signs of allergic reaction) – if this happens stop using the drops

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Keep all medicines out of the sight and reach of children.

Use by the date on the end flap of the carton. Throw away any unused drops 28 days after first opening.

Active ingredients

These eye drops contain Cetrimide 0.01% w/v, Hamamelis Water 5% v/v.

Also contains: purified water, boric acid, borax.

PL 00014/5237

[P]

Text prepared 11/07

Manufactured for the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA

by

Hamol Limited Nottingham NG90 2DB

If you need more advice ask your pharmacist.

BTC16394 vE 28/02/08


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Mycelex-7 Combo Pack Cream


Pronunciation: kloe-TRIM-a-zole
Generic Name: Clotrimazole
Brand Name: Mycelex-7 Combo Pack
Mycelex-7 Combo Pack Cream is used for:

Treating vaginal yeast infections and relieving external vulvar itching and irritation associated with yeast infection.

Mycelex-7 Combo Pack Cream is an antifungal agent. It works by weakening the cell membrane of the fungus, resulting in the death of the fungus.

Do NOT use Mycelex-7 Combo Pack Cream if: you are allergic to any ingredient in Mycelex-7 Combo Pack Cream you have never had a vaginal yeast infection diagnosed by a doctor you have itching caused by a condition other than a yeast infection you have stomach, shoulder, or lower back pain; fever; chills; nausea; foul-smelling vaginal discharge; or vomiting

Contact your doctor or health care provider right away if any of these apply to you.

Before using Mycelex-7 Combo Pack Cream:

Some medical conditions may interact with Mycelex-7 Combo Pack Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have the blood disease porphyria or a history of liver disease or diabetes, or you have been exposed to HIV if this is the first time you have had vaginal itching and discomfort if you have vaginal yeast infections often (eg, your symptoms return within 2 months) or your symptoms do not clear up with treatment if you are taking antibiotics

Some MEDICINES MAY INTERACT with Mycelex-7 Combo Pack Cream. However, no specific interactions with Mycelex-7 Combo Pack Cream are known at this time.

Ask your health care provider if Mycelex-7 Combo Pack Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Mycelex-7 Combo Pack Cream:

Use Mycelex-7 Combo Pack Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Mycelex-7 Combo Pack Cream. Talk to your pharmacist if you have questions about this information. Mycelex-7 Combo Pack Cream is for vaginal use only. Do not use it rectally or take by mouth. Suppositories - Using the applicator provided, insert 1 suppository high into the vagina at bedtime for 7 days. Mycelex-7 Combo Pack Cream comes with one applicator to be used for all 7 days of treatment. Do not throw away applicator after use. Separate the pieces of the applicator and wash with warm, soapy water immediately after use. Rinse thoroughly. Make sure the applicator is completely dry before the next use. External cream - Squeeze a small amount of cream onto your finger and gently spread the cream onto the itchy, irritated skin outside the vagina as directed by your doctor or on the packaging. Wash your hands immediately after using Mycelex-7 Combo Pack Cream. To clear up your infection completely, use Mycelex-7 Combo Pack Cream for the full course of treatment. Keep using it even if you feel better in a few days. If you miss a dose of Mycelex-7 Combo Pack Cream, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Mycelex-7 Combo Pack Cream.

Important safety information: Mycelex-7 Combo Pack Cream is for vaginal use only. Avoid contact with the eyes, nose, or mouth. If you get Mycelex-7 Combo Pack Cream in your eyes, flush with a generous amount of cool water. Be sure to use Mycelex-7 Combo Pack Cream for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future. If your symptoms do not improve within 3 days, if they last more than 7 days, or if they get worse, check with your doctor. Do not use Mycelex-7 Combo Pack Cream for itching caused by other conditions. Dry the outside vaginal area completely after showering, bathing, or swimming. Do not go swimming for at least 9 to 12 hours after applying Mycelex-7 Combo Pack Cream. Change out of wet bathing suits or damp workout clothes as soon as possible. Continue using Mycelex-7 Combo Pack Cream even during your menstrual period. Do not use tampons while you are using Mycelex-7 Combo Pack Cream or until all of your symptoms go away. Use unscented pads or pantiliners. Do not have vaginal sexual intercourse while you are using Mycelex-7 Combo Pack Cream. Mycelex-7 Combo Pack Cream may decrease the effectiveness of condoms and diaphragms, increasing the chance of pregnancy or risk of sexually transmitted disease. Do not use tampons, douches, spermicides, or other vaginal products while using Mycelex-7 Combo Pack Cream. If you use topical products too often, your condition may become worse. Mycelex-7 Combo Pack Cream should not be used in CHILDREN younger than 12 years old; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mycelex-7 Combo Pack Cream while you are pregnant. It is not known if Mycelex-7 Combo Pack Cream is found in breast milk. If you are or will be breast-feeding while you use Mycelex-7 Combo Pack Cream, check with your doctor. Discuss any possible risks to your baby. Possible side effects of Mycelex-7 Combo Pack Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Headache; mild vaginal burning, irritation, or itching; stomach cramps.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever or chills; foul-smelling vaginal discharge; nausea; severe or prolonged vaginal burning, irritation, or itching; stomach pain; swelling; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Mycelex-7 Combo Pack side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Mycelex-7 Combo Pack Cream:

Store Mycelex-7 Combo Pack Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Avoid temperatures above 86 degrees F (30 degrees C). Avoid freezing. Store away from heat, moisture, and light. Do not store in the bathroom. Do not use if the wrapper on the applicator or suppository is torn or damaged. Keep Mycelex-7 Combo Pack Cream out of the reach of children and away from pets.

General information: If you have any questions about Mycelex-7 Combo Pack Cream, please talk with your doctor, pharmacist, or other health care provider. Mycelex-7 Combo Pack Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Mycelex-7 Combo Pack Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Mycelex-7 Combo Pack resources Mycelex-7 Combo Pack Side Effects (in more detail) Mycelex-7 Combo Pack Use in Pregnancy & Breastfeeding Mycelex-7 Combo Pack Support Group 0 Reviews for Mycelex-7 Combo Pack - Add your own review/rating Compare Mycelex-7 Combo Pack with other medications Cutaneous Candidiasis Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Vaginal Yeast Infection
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Alavert


loratadine
Dosage Form: tablet, orally disintegrating
Alavert Allergy (Fresh Mint)
Alavert Allergy (Bubble Gum)
Alavert Allergy (Citrus Burst)
(loratadine) DRUG FACTS ACTIVE INGREDIENT (IN EACH TABLET)

Loratadine 10 mg

PURPOSE

Antihistamine

USES

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose sneezing itchy, watery eyes itching of the nose or throat Warnings Do not use

if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product

do not use more than directed. Taking more than recommended may cause drowsiness.

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS tablet melts in mouth. Can be taken with or without water. Age Dose adults and children 6 years and over 1 tablet daily; do not use more than 1 tablet daily children under 6 ask a doctor consumers who have liver or kidney disease ask a doctor OTHER INFORMATION Phenylketonurics: Contains Phenylalanine 8.4 mg per tablet store at 20-25?C (68-77?F) keep in a dry place

INACTIVE INGREDIENTS Alavert Allergy Fresh Mint

artificial & natural flavors, anhydrous citric acid, aspartame, colloidal silicone dioxide, corn syrup solids, crospovidone, magnesium stearate, mannitol, microcrystalline cellulose, modified food starch, sodium bicarbonate

Alavert Allergy Bubble Gum

anhydrous citric acid, artificial and natural flavor, ascorbic acid, aspartame, colloidal silicon dioxide, crospovidone, ferric oxide, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified starch, sodium bicarbonate

Alavert Allergy Citrus Burst

anhydrous citric acid, aspartame, butylated hydroxyanisole, colloidal silicon dioxide, corn syrup solids, crospovidone, dextrin, ferric oxides, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified food starch, natural & artificial flavors, sodium bicarbonate

QUESTIONS OR COMMENTS?

call weekdays from 9 AM to 5 PM EST at 1-800-Alavert (1-800-252-8378)

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

Alavert allergy Fresh Mint

Loratadine Orally Disintegrating Tablet, 10 mg, Antihistamine

30 Orally Disintegrating Tablets

Melts in your mouth!

Non-Drowsy* Allergy Relief

*When taken as directed. See Drug Facts Panel.

24 HOUR Relief of

Sneezing Runny Nose Itchy, Watery Eyes Itching of Nose & Throat

Compare to Claritin† & SAVE!

†Claritin is a registered trademark of Schering Corporation

Alavert Allergy provides 24 hours of allergy symptom relief without causing drowsiness when taken as directed (See Drug Facts Panel). It contains prescription strength loratadine.

Just one tablet a day relieves runny nose, sneezing and itchy, watery eyes. It is safe and effective for adults and children 6 years and over.

The Fresh Mint flavored tablet melts in your mouth. So convenient, it can be taken without water.

For most recent product information, visit www.Alavert.com

Wyeth

Distributed by:

Wyeth Consumer Healthcare

Madison, NJ 07940 U.S.A.

©2009 Wyeth

EACH TABLET IS BLISTER SEALED. DO NOT USE IF SEAL IS BROKEN.

For Ages 6+

Alavert allergy Bubble Gum Flavor

Loratadine Orally Disintegrating Tablet, 10 mg, Antihistamine

12 Orally Disintegrating Tablets

No Water Needed!

24 HOUR Non-Drowsy* Allergy Relief

*When taken as directed. See Drug Facts Panel.

Itching of Nose & Throat Itchy, Watery Eyes Sneezing Runny Nose

Alavert Allergy provides 24 hours of allergy symptom relief without causing drowsiness when taken as directed (See Drug Facts Panel). It contains prescription strength loratadine. Just one tablet a day relieves runny nose, sneezing and itchy, watery eyes. It is safe and effective for adults and children 6 years and over. The Bubble Gum flavored tablet melts in your mouth. So convenient, it can be taken without water. Visit our website at www.Alavert.com

Distributed by: Wyeth Consumer Healthcare, Madison, NJ 07940 U.S.A. ©2008 Wyeth

EACH TABLET IS BLISTER SEALED. DO NOT USE IF SEAL IS BROKEN.

For Ages 6+

Alavert allergy Citrus Burst

Loratadine Orally Disintegrating Tablet, 10 mg, Antihistamine

12 Orally Disintegrating Tablets

No Water Needed!

24 HOUR Non-Drowsy* Allergy Relief

*When taken as directed. See Drug Facts Panel.

Itching of Nose & Throat Itchy, Watery Eyes Sneezing Runny Nose

Alavert Allergy provides 24 hours of allergy symptom relief without causing drowsiness when taken as directed (See Drug Facts Panel). It contains prescription strength loratadine. Just one tablet a day relieves runny nose, sneezing and itchy, watery eyes. It is safe and effective for adults and children 6 years and over. The Citrus Burst flavored tablet melts in your mouth. So convenient, it can be taken without water. Visit our website at www.Alavert.com

Distributed by: Wyeth Consumer Healthcare, Madison, NJ 07940 U.S.A. ©2008 Wyeth

EACH TABLET IS BLISTER SEALED. DO NOT USE IF SEAL IS BROKEN.


Alavert ALLERGY 
loratadine  tablet, orally disintegrating Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-2620 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength loratadine (loratadine) loratadine 10 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color WHITE (off white) Score no score Shape ROUND ( beveled tablet) Size 14mm Flavor MINT Imprint Code A;24 Contains          Packaging # NDC Package Description Multilevel Packaging 1 0573-2620-06 1 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2620-06) 2 0573-2620-12 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2620-12) 3 0573-2620-19 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 3 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2620-19) 4 0573-2620-30 5 BLISTER PACK In 1 CARTON contains a BLISTER PACK 4 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2620-30) 5 0573-2620-48 8 BLISTER PACK In 1 CARTON contains a BLISTER PACK 5 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2620-48) 6 0573-2620-02 1500 POUCH In 1 BOX contains a POUCH 6 1 TABLET In 1 POUCH This package is contained within the BOX (0573-2620-02) 7 0573-2620-65 10 BLISTER PACK In 1 CARTON contains a BLISTER PACK 7 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2620-65)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021375 12/19/2002
Alavert ALLERGY 
loratadine  tablet, orally disintegrating Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-2621 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength loratadine (loratadine) loratadine 10 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color ORANGE (an orange flat faced tablet) Score no score Shape ROUND (beveled tablet) Size 14mm Flavor CITRUS (orange mint) Imprint Code A;24 Contains          Packaging # NDC Package Description Multilevel Packaging 1 0573-2621-12 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2621-12) 2 0573-2621-18 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2621-18) 3 0573-2621-48 8 BLISTER PACK In 1 CARTON contains a BLISTER PACK 3 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2621-48) 4 0573-2621-65 10 BLISTER PACK In 1 CARTON contains a BLISTER PACK 4 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2621-65) 5 0573-2621-72 12 BLISTER PACK In 1 CARTON contains a BLISTER PACK 5 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2621-72) 6 0573-2621-19 3 BLISTER PACK In 1 CARTON contains a BLISTER PACK 6 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2621-19)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021375 12/19/2002
Alavert ALLERGY 
loratadine  tablet, orally disintegrating Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-2623 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength loratadine (loratadine) loratadine 10 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color PINK (pink) Score no score Shape ROUND (beveled tablet) Size 14mm Flavor BUBBLE GUM (bubblegum flavor) Imprint Code A;24 Contains          Packaging # NDC Package Description Multilevel Packaging 1 0573-2623-12 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2623-12)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021375 12/19/2002
Alavert ALLERGY 
loratadine  tablet, orally disintegrating Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0573-2624 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength loratadine (loratadine) loratadine 10 mg Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found Product Characteristics Color ORANGE (an orange flat faced tablet) Score no score Shape ROUND (beveled tablet) Size 14mm Flavor CITRUS (orange mint) Imprint Code A;24 Contains          Packaging # NDC Package Description Multilevel Packaging 1 0573-2624-12 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 6 TABLET In 1 BLISTER PACK This package is contained within the CARTON (0573-2624-12)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021375 12/19/2002
Labeler - Pfizer Consumer Healthcare (828831730) Revised: 06/2010Pfizer Consumer Healthcare
More Alavert resources Alavert Side Effects (in more detail) Alavert Use in Pregnancy & Breastfeeding Alavert Drug Interactions Alavert Support Group 0 Reviews for Alavert - Add your own review/rating Alavert Syrup MedFacts Consumer Leaflet (Wolters Kluwer) Loratadine Monograph (AHFS DI) Loratadine Professional Patient Advice (Wolters Kluwer) Claritin Consumer Overview Claritin 24 Hour Allergy MedFacts Consumer Leaflet (Wolters Kluwer) Claritin Liqui-Gels MedFacts Consumer Leaflet (Wolters Kluwer) Compare Alavert with other medications Hay Fever Urticaria
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