Active Ingredient (In Each Softgel)
Simethicone 250 mg
Maximum Strength Gas Relief
FDA Label NDC 51013-424
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 51013-424). 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, 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
Use
relieves bloating, pressure or fullness commonly referred to as gas
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 toll free: 1-800-719-9260
Principal Display Panel
MB MAXIMUM STRENGTH Gas Relief
SIMETHICONE 250 mg 24 SOFTGELS
NDC 51013-424-04
Compare to PHAZYME® Maximum Strength active ingredient*
Ht05-00-front (Ht05 00 Front)
Ht05-00-back (Ht05 00 Back)
* Please review the disclaimer below.
