Extra Strength Gas Relief
FDA Label NDC 21130-317
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands Llc for the product Extra Strength Gas Relief (NDC 21130-317). 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 drug facts, active ingredient (in each softgel), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Simethicone 125 mg
Purpose
Antigas
Uses
for the relief of • pressure, bloating, and fullness commonly referred to as gas
Warnings
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Directions
• adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician
Other Information
• store at controlled room temperature 20-25°C (68-77°F)
• protect from light, heat, and moisture
Inactive Ingredients
FD&C Blue No. 1, FD&C Yellow No. 10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide
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