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Drug Facts
DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY
LAKELAND, FL 33811
Guaifenesin Tablet, Extended Release
FDA Label NDC 41415-997
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets, Inc for the product Guaifenesin (NDC 41415-997). 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 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 Tablet)
Guaifenesin, USP 1200 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 (1-800-222-1222).
Directions
- do not crush, chew, or break extended-release 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 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours.
- children under 12 years of age: do not use
Other Information
- store between 68-77°F (20-25°C)
- TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN OR IF PRINTED SEAL ON BLISTER IS BROKEN OR MISSING.
Inactive Ingredients
colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.
Principal Display Panel - 1200 Mg Extended-Release Tablet Blister Pack Carton
NDC 41415-997-14
12-HOUR MAXIMUM STRENGTH
mucusrelief
GUAIFENESIN EXTENDED-RELEASE
TABLETS, 1200 mg
EXPECTORANT
12 Hour
- Relieves Chest Congestion
- Thins and Loosens Mucus
14
EXTENDED-RELEASE
TABLETS
†Compare to the active
ingredient of Mucinex®
Maximum Strength
Principal Display Panel (1200 mg Extended-Release Tablet Blister Pack Carton)
* Please review the disclaimer below.
