Otc - Active Ingredient
Active ingredient (in each softgel)
Simethicone USP 180 mg
Simethicone Capsule, Liquid Filled
FDA Label NDC 35916-1939
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Softgel Healthcare Private Limited for the product Simethicone (NDC 35916-1939). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Bulk Label (Simethicone 180mg)
* Please review the disclaimer below.
