Active Ingredient (In Each Tablet)
Simethicone 125 mg
Extra Strength Gas Relief Tablet, Chewable
FDA Label NDC 21130-441
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Extra Strength Gas Relief (NDC 21130-441). 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), keep out of reach of children, directions, other information, inactive ingredients, principal display panel, 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 and fullness commonly referred to as gas
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a poison control center immediately.
Directions
▪ adults and Childrens 12 years and older: 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
▪ each tablet contains: calcium 45 mg▪ store at room temperature▪ protect from moisture
Inactive Ingredients
D&C red # 30 aluminum lake, D&C yellow # 10 aluminum lake, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, sorbitol, sucrose
Principal Display Panel
*Compare to the active ingredient in Gas-X Extra Strength
NDC 21130-441-48
Extra strength
Gas Relief
Simethicone 125 mg/Anti-Gas
Fast Relief of Pressure, Bloating & Discomfort
Peppermint Flavor
Naturally and Artificially Flavored
18 Chewable Tablets
*This product is not manufactured or distributed by GSK Consumer Healthcare, the distributor of Gas-X Extra Strength.
IMPORTANT: Keep this carton for future reference on full labeling. |
Extra Strength Gas Relief 18 Chewable Tablets (134ppt)
* Please review the disclaimer below.
