Active Ingredient (In Each Softgel)
Simethicone 250 mg
Cvs Health Gas Relief Softgel Capsule, Liquid Filled
FDA Label NDC 51316-311
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc for the product Cvs Health Gas Relief Softgel (NDC 51316-311). 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, uses, 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
Anti-gas
Uses
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 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 per 24 hours except under the advice and supervision of a physician
Other Information
• store at room temperature between 20-25°C (68-77°F)
• protect from light, heat and moisture
Inactive Ingredients
D&C Red No. 33, edible ink, FD&C Blue No. 1, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, purified water, soy lecithin
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