FDA Label for Gas Relief
View Indications, Usage & Precautions
Gas Relief Product Label
The following document was submitted to the FDA by the labeler of this product United Natural Foods, Inc. Dba Unfi. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Chewable Tablet)
Simethicone 125 mg
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
* Please review the disclaimer below.