GUAIFENESIN
Drug Facts
3867a132-1a87-5e08-e063-6294a90a6dc8
HUMAN OTC DRUG LABEL
Aug 1, 2025
Sam's West Inc
DUNS: 051957769
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 (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton (56 (4 x 14)
Tablets)
Member's
Mark™****
COMPARE TO** MAXIMUM STRENGTH**
MUCINEX®***ACTIVE INGREDIENT
NDC 68196-960-56
MAXIMUM STRENGTH
Mucus Relief
****GUAIFENESIN EXTENDED-RELEASE TABLETS, 1200 mg
********GUAIFENESIN 1200 mg-EXPECTORANT
Relieves chest congestion
Actual Size
56
Extended-Release
Tablets
*Relieves chest congestion *Thins and loosens mucus
12
HR
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
WARNINGS SECTION
Warnings
Do not use
OTC - DO NOT USE SECTION
- for children under 12 years of age
OTC - ASK DOCTOR SECTION
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 SECTION
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 SECTION
**If pregnant or breast-feeding,**ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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).
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
(in each extended-release tablet)
Guaifenesin USP 1200 mg
OTC - PURPOSE SECTION
Purpose
Expectorant
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 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 20° to 25°C (68° to 77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)
Questions?
1-855-274-4122(Monday – Friday 8:30 AM to 5:00 PM EST)
DISTRIBUTED BY:
SAM'S WEST, INC.
BENTONVILLE AR 72716
Made in India