Active Ingredient (In Each Softgel)
Simethicone 180 mg
Gas Relief
FDA Label NDC 51013-115
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 Gas Relief (NDC 51013-115). 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, directions, other information, inactive ingredients, questions or comments?, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-gas
Uses
Relieves bloating, pressure or fullness commonly referred to as gas
Directions
- swallow one or two softgels as needed after a meal
- do not exceed two softgels per day except under the advice and supervision of a physician.
Other Information
- store at room temperature 59° - 86°F (15° - 30°C)
Inactive Ingredients
FD&C yellow#6, gelatin, glycerin, purified water and white edible ink
Questions Or Comments?
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Principal Display Panel
ULTRA STRENGTH Gas Relief
Simethicone 180 mg Antigas
NDC 51013-115-01
*Compare to the active ingredient in PHAZYME® Ultra Strength
* Please review the disclaimer below.
