Active Ingredient (In Each Softgel)
Simethicone 180 mg
Ultra Strength Gas Relief
FDA Label NDC 51013-428
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 Ultra Strength Gas Relief (NDC 51013-428). 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
Antigas
Uses
for the relief of
- pressure and bloating commonly referred to as gas
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 controlled room temperature 15° - 30°C (59° - 86°F)
- protect from heat and moisture
Inactive Ingredients
FD&C yellow#6, gelatin, glycerin, purified water and white ink
Questions Or Comments?
Call: 1-855-215-8180
Principal Display Panel
Ultra Strength Gas Relief
Simethicone 180 mg Antigas 50 Softgels
NDC 51013-428-09
*Compare to the active ingredient in Gas-X® Ultra Strength
Ultra Strength Gas Relief 50ct (2)
* Please review the disclaimer below.
