Active Ingredient (In Each Softgel)
Simethicone 125 mg
Extra Strength Simethicone Antigas
FDA Label NDC 81362-302
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lls Health Llc for the product Extra Strength Simethicone Antigas (NDC 81362-302). 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, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, 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.
Warnings
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 20° to 25°C (68° to 77°F)
- protect from light, heat and moisture
Inactive Ingredients
FD&C blue #1, FD&C yellow #10, gelatin, glycerin, peppermint oil, povidone, purified water, sorbitol 70% solution, titanium dioxide.
Questions?
call 1-844-735-0202
Package Labeling:
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