Guaifenesin 600 mg
Drug Facts
525fda90-134c-f038-c403-eb5ffc1fb1f1
HUMAN OTC DRUG LABEL
Sep 22, 2025
Dr. Reddy's Laboratories Inc.
DUNS: 802315887
Products 2
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)
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
Principal Display Panel - 1200 mg Carton
Guaifenesin Extended-Release Tablets****1200 mg Carton Label
INDICATIONS & USAGE SECTION
Use(s)
- helps loosen phlegum (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
OTC - ACTIVE INGREDIENT SECTION
Active ingredient(s)
Guaifenesin 600 mg (for 600mg)
Guaifenesin 1200 mg (for 1200 mg)
OTC - PURPOSE SECTION
Purpose
Expectorant
WARNINGS SECTION
Warnings
Applicable warning(s) in 201.66(c)(5)(i) and (ii)
Do not use
- For children under 12 years age
Ask a doctor before use if
-
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 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 Pregnancy/Breastfeeding,
ask a health professional before use.
Keep out of reach of children
In case of overdose, get medical help or contact aPoison Control Center right away (1-800-222-1222).
DOSAGE & ADMINISTRATION SECTION
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: 1or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (for 600 mg)
- 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 (for 1200 mg)
- children under 12 years of age: do not use
SPL UNCLASSIFIED SECTION
Distributed by:
Dr. Reddy’s Laboratories, Inc.
Princeton, NJ 08540
Made in India
I 0721
INACTIVE INGREDIENT SECTION
Inactive ingredients
carbomer homopolymer type B, colloidal silicon dioxide, ferric oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate type A
OTC - QUESTIONS SECTION
Questions?
call** 1-888-375-3784** Weekdays (8am - 8pm EST)
You may also report side effects to this phone number.