Active Ingredient (In Each Tablet)
Simethicone 125 mg
Kroger Extra Strength Tablet, Chewable
FDA Label NDC 30142-481
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Kroger Extra Strength (NDC 30142-481). 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, uses, 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
Uses
for the relief of
▪ pressure, bloating and fullness commonly referred to as gas
Directions
▪ adults: chew 1 to 2 tablets as needed after meals and at bedtime. Do not swallow tablets whole.▪ do not exceed 4 tablets in a 24 hours except under the advice and supervision of a physician.
Other Information
▪ each tablets contains: calcium 45 mg▪ store at room temperature▪ protect from excessive heat and moisture
TAMPER EVIDENT: DO NOT USE IF ANY INDVIDUAL BLISTER IS BROKEN OR OPEN
Inactive Ingredients
D&C Red No. 30, dextrose, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sucralose, tribasic calcium phosphate.
Principal Display Panel
NDC 30142-481-48
*Compare to the active ingredient in GAS-X® Extra Strength
Extra Strength
Gas Relief
Simethicone//Anti-gas
For Fast Relief of Pressure,
Bloating & Gas Distress
Cherry Creme Flavor
Naturally and Artificially Flavored
48 Chewable Tablets
Distributed by:
*This product is not manufactured or distributed by GSK Consumer Healthcare, Inc., the distributor of Gas-X® Extra strength.
IMPORTANT: Keep this carton for future reference on full labeling. |
Kroger Extra Strength Gas Relief Simethicone (Sm134chr)
* Please review the disclaimer below.
