Guaifenesin Extended-Release
Guaifenesin Extended-Release
608b00c5-a2c7-4514-9b46-02954d6675d6
HUMAN OTC DRUG LABEL
May 27, 2025
Precision Dose Inc.
DUNS: 035886746
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 - 600 mg Tablet Blister Pack Carton
PrecisionDose™
NDC 68094-048-61
Unit Dose
guaiFENesin
Extended-Release
Tablets,
600 mg
100 Tablets
(10 x 10)
(in each extended-release tablet)
Guaifenesin 600 mg....Expectorant.
Directions: do not crush, chew, or
break tablet take with a full glass of water
Unique Bi-Layer Tablet
GLUTEN FREE
USUAL DOSE: See Enclosed Drug Facts
Store at 20-25°C (68-77°F)
Keep out of reach of children.
Hospital Use Only.
LC1384
R0
Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080
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
Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080
For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com
LI1730 Rev. 10/24
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each extended-release tablet)
Guaifenesin 600 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
- Use as directed per healthcare professional.
- 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
STORAGE AND HANDLING SECTION
Other information
- store at 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
Carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate
OTC - QUESTIONS SECTION
Questions or comments?
1-800-397-9228