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
Guaifenesin Extended Release 600 Mg Tablet
FDA Label NDC 49483-723
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Laboratories, Inc. for the product Guaifenesin Extended Release 600 Mg (NDC 49483-723). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient section, otc - purpose section, indications & usage section, otc - do not use section, otc - ask doctor section, otc - stop use section, otc - pregnancy or breast feeding section, otc - keep out of reach of children section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 ingredientscolloidal 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
Guaifenesin-1200mg-70ct-label (Guaifenesin 1200mg 70ct Label)
Guaifenesin-600mg-500ct-label (Guaifenesin 600mg 500ct Label)
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