FDA Label for Mucinex
View Indications, Usage & Precautions
Mucinex Product Label
The following document was submitted to the FDA by the labeler of this product Dispensing Solutions, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by:
Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
©RBI 2009
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
Otc - Do Not Use
Do not use
- for children under 12 years of age
Otc - Ask Doctor
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)
Otc - Stop Use
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF
Questions?
1-866-MUCINEX (1-866-682-4639)
You may also report side effects to this phone number.
Principal Display Panel - 600Mg Tablet
NDC 55045-3143-2
Mucinex ®
600 mg guaifenesin extended-release bi-layer tablets
EXPECTORANT
Chest
Congestion
12
Hour
- Thins And Loosens Mucus
- Relieves Chest Congestion 20 EXTENDED-RELEASE BI-LAYER TABLETS
55045-3143-02 MUCINEX LABEL
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