Otc - Active Ingredient
Active ingredient (in each softgel)
Simethicone USP, 250 mg
Gas Relief Capsule, Liquid Filled
FDA Label NDC 72657-482
10 label sections · Submitted to the FDA by Glenmark Therapeutics Inc., Usa · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Glenmark Therapeutics Inc., Usa for the product Gas Relief (NDC 72657-482). 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, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antigas
Indications & Usage
Use
For the relief of
- pressure, bloating, and fullness commonly referred to as gas
Warnings
Warnings
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
- adults and children 12 years and older: swallow with water 1 or 2 softgels as needed after meals and at bedtime
- do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician
Other Safety Information
Other information
- store at controlled room temperature 20°C to 25°C (68°F to 77°F)
- protect from light, heat, and moisture
Inactive Ingredient
Inactive ingredients
D&C red no.33, FD&C blue no.1, gelatin, glycerin, purified water
Questions Or Comments?
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Distributed by:
Glenmark Therapeutics Inc., USA
Elmwood Park, NJ 07407
Principal Display Panel
NDC 72657-482-15
GAS RELIEF
Simethicone Capsules USP, 250 mg
150 Softgels
Carton250mg (Carton250mg)
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