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Drug Facts
Dist. by: Reckitt Benckiser
Parsippany, NJ 07054-0224
Made in England
Mucinex Tablet, Extended Release
FDA Label NDC 63187-954
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Mucinex (NDC 63187-954). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each extended-release bi-layer tablet), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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.
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 - 40 Tablet Carton
NDC 63187-954-40
Mucinex®
600 mg guaifenesin
extended-release bi-layer tablets
EXPECTORANT
12
HOUR
- Relieves Chest Congestion
- Thins and Loosens Mucus
- Immediate and Extended Release
40
EXTENDED-RELEASE
BI-LAYER TABLETS
63187-954-40 (Mucinex 01)
* Please review the disclaimer below.
