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 Softgel Healthcare Private Limited. 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.
Otc - Active Ingredient
Active ingredient (in each softgel)
Simethicone USP 180 mg
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: 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 20-25°C (68-77°F)
- protect from moisture
- read all product information before using.
- Keep this box for important information
Inactive Ingredient
Inactive ingredients
FD&C yellow no.6, gelatin, glycerin, peppermint oil, purified water, sorbitol, titanium dioxide
Principal Display Panel
NDC 35916-1939-2
Compare to Gas-X ® Ultra Strength Active Ingredient*
Simethicone Capsules USP, 180 mg
Simethicone 180 mg / Antigas
RELIEVES GAS FAST:
- Pressure
- Bloating
- Discomfort
50 Softgels
Bulk Package Label
* Please review the disclaimer below.
