Active Ingredient (In Each Chewable Tablet)
Simethicone 125 mg
Gas Relief Tablet, Chewable
FDA Label NDC 83324-325
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Gas Relief (NDC 83324-325). 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?
1-800-426-9391
Principal Display Panel
NDC 83324-325-18
Extra Strength
Gas
Relief
Simethicone 125 mg
Chewable Tablets
Antigas
Relieves:
Pressure
Bloating
Discomfort
Cherry Flavored
Do not swallow
tablets whole.
Chew or crush tablets
completely
before swallowing.
Actual Size
*This product is not manufactured or distributed by Haleon CH SARL, owner of
the registered trademark Gas-X® Extra Strength. 50844 ORG122060844
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING
Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
• SATISFACTION
100%
QC®
GUARANTEED •
Quality Choice 44-608 (Quality Choice 44 608 1)
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