Active Ingredient (In Each Softgel)
Simethicone 180 mg
Gas Relief
FDA Label NDC 36800-963
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Top Care (topco Associates Llc) for the product Gas Relief (NDC 36800-963). 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, use, 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
Use
For the relief of
- pressure and bloating commonly referred to as gas
If Pregnant Or Breast-Feeding,
ask a health care professional before use.
Directions
- adult: swallow with water 1 or 2 softgels as needed after meals and at bedtime
- do not exceed 2 softgels in 24 hours except under the advice and supervision of a physician
Other Information
- store between 15-30°C (59-86°F)
- protect from heat and moisture
Inactive Ingredients
FD&C red #40*,FD&C yellow # 6, gelatin, glycerin
Questions Or Comments?
Calltoll free 1-888-423-0139
Principal Display Panel
COMPARE TO GAS-X® ULTRA STRENGTH ACTIVE NGREDIENT*
ULTRA STRENGTH
Gas Relief
ANTI-GAS/SIMETHICONE, 180 mg
FAST RELIEF OF
- Bloating
- Pressure
- Fullness & Gas
SOFTGELS
**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Gas-X® Ultra 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 TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
Package Label
TOPCARE HEALTH Ultra Strength Gas Relief
* Please review the disclaimer below.
