Otc - Active Ingredient
Active ingredient (in each softgel)
Simethicone 180 mg
Ultrastrength Gas Relief Capsule
FDA Label NDC 51316-621
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 Ultrastrength Gas Relief (NDC 51316-621). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Anti-gas
Indications & Usage
Use for the relief of
- pressure and bloating commonly referred to as gas.
Warnings
​Warning
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
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 Safety Information
Other information
- store at room temperature
- protect from light, heat and moisture
Inactive Ingredient
Inactive ingredients
FD&C yellow no. 6, gelatin, glycerol, medium chain triglyceride, peppermint oil, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide
Otc - Questions
Questions or comments? Call 1-877-290-4008
Package Label.Principal Display Panel
Cvs_721t_50ct (Cvs 721t 50ct)
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