Mucinex

Generic Name: guaifenesin

Dosage Form: tablet, extended release
Mucinex®

Drug Facts

Active ingredient (in each extended-release bi-layer tablet)

Guaifenesin 600 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Do not use

• for children under 12 years of age

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)

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 the timing of meals


• adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 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 between 20-25°C (68-77°F)

Inactive ingredients

carbomer 934P, NF; FD&C blue #1 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 Tablet Carton

NDC 63824-008-32

Mucinex®

600 mg guaifenesin extended-release bi-layer tablets

EXPECTORANT

12

HOUR

NEW LOOK –

SAME RELIEF

✔

Thins And Loosens Mucus

✔

Relieves Chest Congestion

20 EXTENDED-RELEASE BI-LAYER TABLETS

Mucinex  guaifenesin  tablet, extended release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 63824-008 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Guaifenesin (Guaifenesin) Guaifenesin 600 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE (blue and white) Score no score Shape OVAL Size 16mm Flavor Imprint Code Mucinex;600 Contains

Packaging # NDC Package Description Multilevel Packaging 1 63824-008-32 2 BLISTER PACK In 1 CARTON contains a BLISTER PACK 1 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (63824-008-32) 2 63824-008-34 4 BLISTER PACK In 1 CARTON contains a BLISTER PACK 2 10 TABLET In 1 BLISTER PACK This package is contained within the CARTON (63824-008-34) 3 63824-008-10 1 BOTTLE In 1 CARTON contains a BOTTLE 3 100 TABLET In 1 BOTTLE This package is contained within the CARTON (63824-008-10) 4 63824-008-50 1 BOTTLE In 1 CARTON contains a BOTTLE 4 500 TABLET In 1 BOTTLE This package is contained within the CARTON (63824-008-50) 5 63824-008-61 1 BOTTLE In 1 BLISTER PACK contains a BOTTLE 5 60 TABLET In 1 BOTTLE This package is contained within the BLISTER PACK (63824-008-61) 6 63824-008-72 25 POUCH In 1 CARTON contains a POUCH 6 2 TABLET In 1 POUCH This package is contained within the CARTON (63824-008-72)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021282	03/27/2009

Labeler - Reckitt Benckiser, Inc. (094405024)

Revised: 12/2009Reckitt Benckiser, Inc.

More Mucinex resources

• Mucinex Side Effects (in more detail)
• Mucinex Dosage
• Mucinex Use in Pregnancy & Breastfeeding
• Mucinex Support Group
• 38 Reviews for Mucinex - Add your own review/rating

• Mucinex Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Mucinex Consumer Overview


• Mucinex Advanced Consumer (Micromedex) - Includes Dosage Information


• Allfen MedFacts Consumer Leaflet (Wolters Kluwer)


• Guaifenesin Monograph (AHFS DI)


• Guaifenesin Granules MedFacts Consumer Leaflet (Wolters Kluwer)


• Hytuss Immediate-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Tussin Consumer Overview

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