Guaifenesin Extended Release 600 mg / Guaifenesin Extended Release 1200 mg
- Dosage form
- TABLET
- Labeler
- TIME CAP LABORATORIES, INC.
- Label updated
- 2024-02-07
- Retrieved
- 2026-09-07
- Active ingredients
- GUAIFENESIN
OTC - ACTIVE INGREDIENT SECTION
For 600 mg:
Active ingredient (in each extended-release tablet)
Guaifenesin, USP 600 mg
For 1200 mg:
Active ingredient (in each extended-release tablet)
Guaifenesin, USP 1200 mg
OTC - PURPOSE SECTION
Purpose
Expectorant
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
OTC - DO NOT USE SECTION
Do not use
• 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 (1-800-222-1222) right away.
DOSAGE & ADMINISTRATION SECTION
Directions
For 600 mg
• 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 or 2 extended - release tablets every 12 hours. Do not exceed 4 extended - release tablets in 24 hours.
• children under 12 years of age: do not use
For 1200 mg
• 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 at 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients colloidal silicon dioxide, copovidone, FD&C blue No. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid
OTC - QUESTIONS SECTION
Questions or comments? Call 1-877-290-4008
PRINCIPAL DISPLAY PANEL
[Image in the official label — see DailyMed source]
[Image in the official label — see DailyMed source]
DailyMed Set ID: 10c42869-7df0-3046-e063-6394a90aa679 · Version 1
NDC: 49483-723, 49483-724