Active Ingredient (In Each Softgel)
Simethicone 250 mg
Maximum Strength Gas Relief
FDA Label NDC 51013-127
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Maximum Strength Gas Relief (NDC 51013-127). 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, use, stop use and ask a doctor if, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-gas
Use
- relieves bloating, pressure or fullness commonly referred to as gas
Stop Use And Ask A Doctor If
condition persists
Directions
- swallow one or two softgels after a meal
- do not exceed two softgels per 24 hours except under the advice and supervision of a physician
Other Information
- store at room temperature 59°-86°F (15°-30°C)
Inactive Ingredients
D&C red #33, FD&C blue #1, gelatin, glycerin, purified water, and white edible ink
Questions Or Comments?
Call: 1-855-215-8180
Principal Display Panel - 24Ct
CVS MAXIMUM STRENGTH GAS RELIEF Anti-gas
SIMETHICONE 250 mg
NDC 51013-127-04
Compare to the active ingredient in PHAZYME® Maximum Strength
24 Liquid-Filled SoftGels
Carton 24ct (Simethicone 24ct)
Principal Display Panel - 60Ct
CVS MAXIMUM STRENGTH GAS RELIEF Anti-gas
SIMETHICONE 250 mg
NDC 51013-127-22
Compare to the active ingredient in PHAZYME® Maximum Strength
60 Liquid-Filled SoftGels
Carton 60ct (Simethicone 60ct)
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