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 Pvt Ltd. 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 250 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 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
* Please review the disclaimer below.
