Active Ingredient (In Each Softgel)
Simethicone 125 mg
Gas Relief Capsule, Liquid Filled
FDA Label NDC 0904-6994
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Gas Relief (NDC 0904-6994). 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, if pregnant or breast-feeding,, 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
Antigas
Uses
- for the relief of pressure, bloating, and fullness commonly referred to as gas
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Directions
- adults: swallow with water 1 or 2 softgels as needed after meals and at bedtime
- do not exceed 4 softgels in 24 hours except under the advice and supervision of a physican
Other Information
- store between 20-25°C (68-77°F)
- do not refrigerate
- protect from light, heat, and moisture
Inactive Ingredients
D&C yellow #10, edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, mannitol, peppermint oil, purified water, sorbitan, sorbitol, titanium dioxide
Questions Or Comments?
Call 1-800-616-2471
Principal Display Panel
†Compare to the active ingredient in Gas-X® Extra Strength
Gas Relief
Simethicone 125 mg / Antigas
FAST RELIEF OF
PRESSURE • BLOATING • DISCOMFORT
EXTRA STRENGTH
SOFTGELS
†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X Extra Strength.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by:
MAJOR PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Product Label
MAJOR Gas Relief
* Please review the disclaimer below.
