Cvs Health Ultra Strength Gas Relief
FDA Label NDC 51316-108
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 for the product Cvs Health Ultra Strength Gas Relief (NDC 51316-108). 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) simethicone 180 mg, purpose antigas, usefor the relief of ■ pressure and bloating commonly referred to as gas, warnings, 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 2 softgels in 24 hours except under the advice and supervision of a physician, other information■ store at a controlled room temperature 20-25°c (68-77°f) ■ protect from heat and moisture, 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
Usefor The Relief Of ■ Pressure And Bloating Commonly Referred To As Gas
Warnings
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 2 Softgels In 24 Hours Except Under The Advice And Supervision Of A Physician
Other Information■ Store At A Controlled Room Temperature 20-25°C (68-77°F) ■ Protect From Heat And Moisture
Inactive Ingredientsfd&C Yellow #6, Gelatin, Glycerin, Peppermint Oil, Povidone, Purified Water, Sorbitol Solution, Titanium Dioxide
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