Guaifenesin Extended-release Tablets 600 Mg And 1200 Mg
10c42869-7df0-3046-e063-6394a90aa679
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
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
Purpose
Purpose Expectorant
Storage and Handling
Other information • store at 20-25°C (68-77°F)
Medication Information
Purpose
Purpose Expectorant
Storage and Handling
Other information • store at 20-25°C (68-77°F)
Description
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
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 Questions Section
Questions or comments? Call 1-877-290-4008
Principal Display Panel
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 Do Not Use Section
Do not use
• for children under 12 years of age
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
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
Storage and Handling Section
Other information
• store at 20-25°C (68-77°F)
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
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 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.
Structured Label Content
Otc Purpose Section (OTC - PURPOSE SECTION)
Purpose
Expectorant
Otc Stop Use Section (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 Questions Section (OTC - QUESTIONS SECTION)
Questions or comments? Call 1-877-290-4008
Principal Display Panel (PRINCIPAL DISPLAY PANEL)
Otc Ask Doctor Section (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 Do Not Use Section (OTC - DO NOT USE SECTION)
Do not use
• for children under 12 years of age
Inactive Ingredient Section (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
Indications & Usage Section (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
Storage and Handling Section (STORAGE AND HANDLING SECTION)
Other information
• store at 20-25°C (68-77°F)
Dosage & Administration Section (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
Otc Active Ingredient Section (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 Pregnancy Or Breast Feeding Section (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 (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.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:46.122465 · Updated: 2026-03-14T23:02:29.359860