Otc - Active Ingredient
Active ingredient (in each softgel)
Simethicone USP 125 mg
Simethicone Capsule, Liquid Filled
FDA Label NDC 35916-1938
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 Pvt Ltd for the product Simethicone (NDC 35916-1938). 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
Warning
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 4 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 yellow no.10, FD&C blue no. 1, FD&C red no.40, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan solution, titanium dioxide
Principal Display Panel
Compare to Gas-X ® Extra Strength Active Ingredient*
NDC 35916-1938-2
Simethicone Capsules USP, 125 mg
Simethicone 125 mg / Antigas (Relieves Gas Fast)
Pressure, Bloating, Discomfort
30 Softgels
* Please review the disclaimer below.
