Maximum Strength Gas Relief Softgel Capsule, Liquid Filled
FDA Label NDC 51316-813
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 Maximum Strength Gas Relief Softgel (NDC 51316-813). 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 250 mg
Purpose
Anti-gas
Uses
• relieves bloating, pressure or fullness commonly referred to as gas
Warnings
Stop use and ask a doctor if condition persists.
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
• Swallow one or two softgels as symptoms occur
• do not exceed 2 softgels per 24 hours except under the advice and supervision of a physician
Other Information
• store at room temperature 20-25°C (68-77°F)
• protect from heat, humidity and light
Inactive Ingredients
D&C red #33, edible ink, FD&C blue #1, gelatin, glycerin, purified water
Questions Or Comments?
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Packaging
Cvs-813 (51316788 36)
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