Active Ingredient (In Each Softgel)
Simethicone 125mg
Simethicone
FDA Label NDC 55629-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by One2zee Limited Liability Company for the product Simethicone (NDC 55629-010). 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 active ingredient (in each softgel), purpose, use, keep out of reach of children., directions, other information, inactive ingredients, principal display panel - shipping label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antigas
Use
for the relief of
- pressure, bloating, and fullness commonly referred to as gas
Keep Out Of Reach Of Children.
Directions
- adults: 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 Information
- store at controlled room temperature 20-25°C (68-77°F)
- protect from light, heat, and moisture
Inactive Ingredients
FD&C blue 1, FD&C yello#10, gelatin, glycerin, peppermint oil, purified water, sorbitol sorbitan, titanium dioxide
Principal Display Panel - Shipping Label
IMETHICONE CAPSULES, 325 mg
Quantity : 48 Bags of 1500 Capsules each
NDC. No : 55629-010-01
Important:
1. Inspect immediately upon receipt
2. This is bulk shipment intended for further processing only
3. store at controlled room temperature 20-25°C (68-77°F), protect from light, heat, and moisture
* Please review the disclaimer below.
