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Drug Facts
Gas Relief Extra Strength Capsule, Liquid Filled
FDA Label NDC 36800-785
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Gas Relief Extra Strength (NDC 36800-785). 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 other, active ingredient (in each softgel), purpose, use, otc - keep out of reach of children, directions, other information, inactive ingredients, 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
Use
for the relief of
- Pressure, bloating, and fullness commonly referred to as gas
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 between 20-25°C (68-77°F)
- protect from heat and moisture
Inactive Ingredients
D&C yellow #10, FD&C blue #1, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol sorbitan solution, titanium dioxide
Questions?
Call 1-888-423-0139
Principal Display Panel - 50 Softgel Blister Pack Carton
NDC 36800-801-67
*Compare to the active ingredient
in Gas-X® Extra Strength
Extra Strength
Gas Relief
Softgels
ANTIGAS / SIMETHICONE 125mg
FAST RELIF OF
- Bloating
- Pressure
- Fullness & Gas
actual size
50 Softgels
Principal Display Panel (50 Softgel Blister Pack Carton)
* Please review the disclaimer below.
