Otc - Active Ingredient
Active ingredient (in each softgel)
Simethicone USP 250 mg
Simethicone Capsule, Liquid Filled
FDA Label NDC 35916-1940
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 35916-1940). 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 and children 12 years and older: 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 light, heat, and moisture
Inactive Ingredient
Inactive ingredients
D&C red no.33, FD&C blue no.1, gelatin, glycerin, purified water
Principal Display Panel
NDC 35916-1940-2
Compare to Gas-X ® Maximum Strength Active Ingredient*
Simethicone Capsules USP, 250 mg
Simethicone 250 mg / Antigas (Relieves Gas Fast)
RELIEVES GAS FAST:
- Pressure
- Bloating
- Discomfort
50 Softgels
Bulk Package Label
Simethicone-bulk-label (Simethicone 250mg)
* Please review the disclaimer below.
