Active Ingredient(In Each Tablet)
Simethicone 125 mg
Gas Relief Tablet, Chewable
FDA Label NDC 36800-122
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Gas Relief (NDC 36800-122). 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 tablet), purpose, use(s), warnings, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anti-gas
Use(S)
relieves:
- pressure
- bloating
- symptoms referred to as gas
Warnings
.
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a poison control center immediately.
Directions
- chew 1 to 2 tablets thoroughly as needed after meals and at bedtime
- do not exceed 4 tablets in a 24 hour period except under the advice and supervision of a physician
Other Information
- do not use if any individual blister unit is broken or open
- store at room temperature
- avoid high humidity and excessive heat, above 40°C (104°F)
Inactive Ingredients
D&C red # 30 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose
Principal Display Panel
Topcare
NDC 36800-122-73
COMPARE TO GAS-X® EXTRA STRENGTH ACTIVE INGREDIENT*
EXTRA STRENGTH
Gas
Relief
ANTI-GAS/SIMETHICONE, 125 mg
FAST RELIEF OF:
- Bloating
- Pressure
- Discomfort of Gas
CHERRY FLAVOR
18 CHEWABLE TABLETS
75 (134chr)
* Please review the disclaimer below.
