Ultra Strength Gas Relief Softgels Capsule, Liquid Filled
FDA Label NDC 76162-840
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Ultra Strength Gas Relief Softgels (NDC 76162-840). 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 drug facts, active ingredient (in each softgel), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Softgel)
Simethicone 180 mg
Purpose
Antigas
Uses
for the relief of pressure and bloating 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 and children 12 years or 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 Information
• store at controlled room temperature 20-25°C (68-77°F)
• protect from light, heat, and moisture
Inactive Ingredients
ammonium hydroxide, black iron oxide, FD&C Yellow No. 6, gelatin, glycerin, isopropyl alcohol, n-butyl alcohol, peppermint oil, propylene glycol, shellac glaze, sorbitol sorbitan anhydrous, titanium dioxide
Questions Or Comments?
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Packaging
Ultra Strength Gas Relief Softgels (76162840 1)
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