FDA Label for Simethicone
View Indications, Usage & Precautions
Simethicone Product Label
The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Softgel)
Simethicone 125mg
Purpose
Antigas
Use
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
Other Information
- store at controlled room temperature 20-25°C (68-77°F)
- protect from light, heat, and moisture
Inactive Ingredients
FD&C blue 1, FD&C yello#10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide
Questions Or Comments?
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Compare to the active ingredient
in Extra Strength Gas-X®†
Extra Strength Gas Relief
SIMETHICONE 125 MG / ANTIGAS
†This product is not manufactured or distributed by GlaxoSmithKline,
owner of the registered trademark Extra Strength Gas-X®
* Please review the disclaimer below.