Premier Value Tablet, Chewable
FDA Label NDC 68016-811

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance, Llc for the product Premier Value (NDC 68016-811). 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 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

    • 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

Premier Value®

NDC 68016-811-18

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

Extra Strength

Gas Relief

Antigas/Simethicone 125 mg

Relieves:

  • Pressure
  • Bloating
  • Discomfort

    • Cherry Creme Flavor

    Naturally and Artificially Flavored

    18 CHEWABLE TABLETS

    K PAREVE

    *This product is not manufactured or distributed by GSK Consumer Healthcare, Inc. the distributor of Gas-X® Extra strength.

    Distributed by:

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

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

    Premier Value Extra Strength Simethicone (Sm134chr)

    Premier Value Extra Strength Simethicone (Sm134chr)

* Please review the disclaimer below.