Premier Value Maximum Strength Tablet, Chewable
FDA Label NDC 68016-249

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 Maximum Strength (NDC 68016-249). 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 ingredients (in each tablet), purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients (In Each Tablet)

Calcium carbonate 1000 mg

Simethicone 60 mg

Purpose

Antacid

Antigas

Uses

relieves:

  • ▪acid indigestion
  • ▪heartburn
  • ▪sour stomach
  • ▪upset stomach due to these symptoms
  • ▪bloating and pressure commonly referred to as gas

Warnings

Do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Ask A Doctor Before Use If You Have

  • ▪kidney stones
  • ▪a calcium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When Using This Product

at maximum dose, constipation may occur.

Stop Use And Ask A Doctor If

symptoms persist for more than 2 weeks.

Directions

  • adults and children 12 years and older: chew 1 to 2 tablets completely as symptoms occur or as directed by a doctor. Do not swallow tablets whole.
  • ▪do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor.

Other Information

  • ▪each tablet contains: calcium 400 mg
  • ▪store at room temperature
  • ▪keep tightly closed and dry
  • ▪avoid freezing
  • do not use if printed inner seal is broken or missing

Inactive Ingredients

adipic acid, D&C Yellow No. 10, dextrose, FD&C Red No. 40, FD&C Yellow No. 6, flavors, magnesium stearate, maltodextrin, silica, starch, sucralose.

Questions Or Comments?

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Premier Value®

*COMPARE TO THE ACTIVE INGREDIENTS IN MAALOX® ADVANCED MAXIMUM STRENGTH

NDC: 68016-249-00

Antacid & Anti-Gas

MAXIMUM STRENGTH

Fast relief of:

  • ▪Heartburn
  • ▪Acid indigestion
  • ▪Pressure & bloating
  •  Assorted Fruit
  •  Naturally Artificially Flavored
  • 90 Chewable Tablets

    INDEPENDENTLY TESTED PV SATISFACTION GURANTEED

    Distributed by:

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

    If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

    *This product is not manufactured or distributed by Novartis Consumer Health, Inc., the distributor of Maalox® Advanced Maximum Strength.

    Premier Value Maximum Strength Assorted Fruit 90 Chewable Tablets (104af90pvlr.jpeg.png)

    Premier Value Maximum Strength Assorted Fruit 90 Chewable Tablets (104af90pvlr.jpeg.png)

* Please review the disclaimer below.