Active Ingredient (In Each Chewable Tablet)
Simethicone 125 mg
Gas Relief Tablet, Chewable
FDA Label NDC 41163-408
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by United Natural Foods, Inc. Dba Unfi for the product Gas Relief (NDC 41163-408). 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 chewable tablet), 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, bloating, and fullness commonly referred to as gas
Directions
- do not take more than directed
- chew or crush tablets completely before swallowing; do not swallow tablets whole
- adults and children 12 years and over: take 1 or 2 chewable tablets as needed after meals and at bedtime
- do not exceed 4 chewable tablets in 24 hours unless directed by a doctor
- children under 12 years: ask a doctor
Other Information
- each tablet contains: calcium 85 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from moisture
- see end flap for expiration date and lot number
Inactive Ingredients
crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, silicon dioxide, starch, sucralose, tribasic calcium phosphate
Questions Or Comments?
1-855-423-2630
Principal Display Panel
NDC 41163-408-44
Compare to Gas-X®
Extra Strength
active ingredient*
extra strength
gas relief
simethicone 125 mg
chewable tablets
(anti-gas)
cherry flavor
relieves:
•bloating
•pressure
•discomfort
| CHEW OR CRUSH TABLETS COMPLETELY BEFORE SWALLOWING. DO NOT SWALLOW TABLETS WHOLE. |
actual size
18 chewable tablets
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by GSK Consumer Healthcare S.A., owner of the registered trademark Gas-X® Extra Strength.
50844 REV1220B60844
DISTRIBUTED BY UNFI
PROVIDENCE, RI 02908 USA
Equaline 44-608 (Equaline 44 608 1)
* Please review the disclaimer below.
