Guaifenesin
GUAIFENESIN EXTENDED-RELEASE TABLETS
038e1801-b978-4a2e-ae8c-8803596ec09c
HUMAN OTC DRUG LABEL
May 20, 2025
PUBLIX SUPER MARKETS, INC
DUNS: 006922009
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Guaifenesin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
INDICATIONS & USAGE SECTION
Uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
SPL UNCLASSIFIED SECTION
DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,
** 3300 PUBLIX CORPORATE PARKWAY**
** LAKELAND, FL 33811**
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each extended-release tablet)
Guaifenesin, USP 1200 mg
OTC - PURPOSE SECTION
Purpose
Expectorant
WARNINGS SECTION
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 (1-800-222-1222).
DOSAGE & ADMINISTRATION SECTION
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
STORAGE AND HANDLING SECTION
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 INGREDIENT SECTION
Inactive ingredients
colloidal silicon dioxide, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, povidone.