Active Ingredient (In Each Softgel)
Simethicone 125 mg
Gas Relief Capsule, Liquid Filled
FDA Label NDC 72476-897
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Care One (retail Business Services, Llc.) for the product Gas Relief (NDC 72476-897). 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 of 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 Of 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 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to the active ingredient in Gas-X® Extra Strength†
EXTRA STRENGTH
GAS RELIEF
Simethicone 125 mg Antigas
FAST RELIEF OF:
PRESSURE,
BLOATING
DISCOMFORT
SOFTGELS
**This product is not manufactured or distributed GSK Comsumer 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 FOODHOLD U.S.A., LLC
LANDOVER, MD 20785 • 1-877-846-9949
Product Label
CAREONE Extra Strength Gas Relief
* Please review the disclaimer below.
