Premier Value Extra Strength Tablet, Chewable
FDA Label NDC 68016-105

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 Extra Strength (NDC 68016-105). 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, ask a doctor or pharmacist before use if you are, when using this product, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Tablet)

Aluminum hydroxide 160 mg

Magnesium carbonate 105 mg

Purpose

Antacid

Antacid

Uses

relieves

  • ▪acid indigestion
  • ▪heartburn
  • ▪sour stomach
  • ▪upset stomach associated with these symptoms

Ask A Doctor Or Pharmacist Before Use If You Are

  • ▪taking a prescription drug. Antacids may interact with certain prescription drugs
  • ▪If you are on a sodium-restricted diet

When Using This Product

  • ▪do not take more than 16 tablets in 24 hours
  • ▪do not use the maximum dosage for more than 2 weeks

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Directions

  • ▪chew 2 to 4 tablets completely four times a day or as directed by a doctor
  • ▪take after meals and at bedtime or as needed
  • ▪for best results follow by a half glass of water or other liquid
  • ▪DO NOT SWALLOW TABLETS WHOLE

Other Information

  • ▪each tablet contains: magnesium 31 mg, sodium 19 mg
  • ▪Store at room temperature.

Inactive Ingredients

alginic acid, calcium stearate, compressible sugar, flavor, sodium bicarbonate, starch (corn), sucrose.

Questions Or Comments?

1-866-467-2748

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Premier Value®

NDC 68016-105-10

Heartburn Antacid

COMPARE TO THE ACTIVE INGREDIENTS IN EXTRA STRENGTH GAVISCON®

EXTRA STRENGTH

Aluminum Hydroxide, 160 mg

Magnesium Carbonate, 105 mg

  •  Fast-Acting Heartburn Relief
  •  Helps Keep Acid Down for Hours

    • Original Flavor

    100 CHEWABLE TABLETS

    Distributed By:

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue,

    Wayne, PA 19087

    DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS BROKEN OR MISSING

    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 GlaxoSmithKline, the distributor of Gaviscon® Extra Strength Antacid.

    Heartburn Antacid Original Flavor 100 Chewable Tablets (35d01fe6 542e 41fe A81b 49e1077a7e8e 01)

    Heartburn Antacid Original Flavor 100 Chewable Tablets (35d01fe6 542e 41fe A81b 49e1077a7e8e 01)

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