Active Ingredient (In Each Softgel)
Simethicone 125 mg
Assured Gas Relief Extra Strength
FDA Label NDC 33992-0113
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International, Inc. for the product Assured Gas Relief Extra Strength (NDC 33992-0113). 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 active ingredient (in each softgel), purpose, uses, directions, other information, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigas
Uses
for the relief of
- pressure, bloating, and fullness commonly referred to as gas
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
- do not use if any individual blister unit is broken or missing
Other Information
- store at controlled room temperature 20°-25°C (68-77°F)
- protect from light, heat and moisture
Inactive Ingredients
D&C yellow 10, FD&C blue 1, gelatin, glycerin, purified water, titanium dioxide
Principal Display Panel
Compare to active ingredient in Extra Strength Gas-X®
Extra Strength
Gas Relief
Simethicone 125 mg
Anti-Gas
Relieves:
Bloating, Pressure, Fullness, Gas
15 Softgels
Assured Extra Strength Gas Relief Simethicone 125mg (D5b412b4 9121 42e0 8c3f 413810ade6dd 01)
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