Winco Foods Extra Strength Tablet, Chewable
FDA Label NDC 67091-361

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Winco Foods Extra Strength (NDC 67091-361). 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

Active Ingredient (In Each Tablet)

Simethicone 125 mg

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

WinCo® FOODS

NDC 67091-361-18

*Compare to the active ingredient in GAS-X® Extra Strength Chewables

EXTRA STRENGTH

Gas Relief

SIMETHICONE 125 mg/ANTI-GAS

Soothing Relieves for:

Pressure, Bloating & Gas Distress

Cherry Creme Flavor

Naturally And Artificially Flavored

18 Chewable Tablets

DISTRIBUTED BY:

WINCO FOODS, LLC, BOISE, ID 83704

*This product is not manufactured or distributed by GSK CONSUMER HEALTHCARE, INC. distributor of Gas-X® Extra strength Chewables

The Supermarket Low Price Leader®

100% SATISFACTION GUARANTEED

Comments & Questions?

800-824-1706 www.wincofoods.com

IMPORTANT: Keep this carton for future reference on full labeling.

Winco Foods Extra Strength Gas Relief 18 Counts (Sm134chr)

Winco Foods Extra Strength Gas Relief 18 Counts (Sm134chr)

* Please review the disclaimer below.