Premier Value Extra Strength Tablet, Chewable
FDA Label NDC 68016-678

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium, Llc for the product Premier Value Extra Strength (NDC 68016-678). 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 other, active ingredients (in each tablet), purpose, uses, ask a doctor or pharmacist before use if you are, when using this product, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients (In Each Tablet)

Calcium Carbonate USP 675 mg
Magnesium hydroxide USP 135 mg

Purpose

Antacid

Antacid

Uses

relieves:

  • ▪heartburn
  • ▪sour stomach
  • ▪acid indigestion

Ask A Doctor Or Pharmacist Before Use If You Are

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

When Using This Product

  • ▪do not take more than 10 tablets in a 24-hour period or do not use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician.

Directions

  • ▪chew 2-4 tablets, hourly if needed.

Other Information

  • ▪each tablet contains: calcium 270 mg, magnesium 55 mg
  • ▪store between 20-25°C (68-77°F)
  • ▪Avoid high humidity.
  • ▪do not use if printed inner seal is broken or missing

    • CALCIUM SUPPLEMENT

    USES

    As a daily source of extra calcium

    DIRECTIONS

    Chew 2 tablets twice daily

    Supplement Facts

    Serving Size: 2 Tablets

    Servings Per Container: 50

    Amount Per Serving

    % Daily Value

    Calories 8

    Sugars 2g

    Calcium 540 mg

    54%

    Sodium (Sodium Free)

    0%

    *Percent Daily Values (DV) are based on a 2,000 calories diet.

    †Daily Value not established.

Inactive Ingredients

corn starch, dextrose, flavor, magnesium stearate, maltodextrin, sucralose.

Questions?

1-866-467-2748

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Premier Value®

NDC# 68016-678-00

COMPARE TO ACTIVE INGREDIENTS IN ROLAIDS® EXTRA STRENGTH*

Extra Strength

Antacid Tablets

Freshmint Flavor

Relieves:

  • Heartburn
  • Acid Indigestion

    • Antacid/Calcium Supplement

    100 CHEWABLE TABLETS

    GLUTEN FREE

    TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL IS BROKEN OR MISSING

    *This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Extra Strength Rolaids®

    DISTRIBUTED BY CHAIN DRUG CONSORTIUM

    3301 NW BOCA RATON BLVD

    SUITE 101, BOCA RATON, FL 33431

    Premier Value Extra Strength Antacid Tablets (Rolaids Regular Strength Tablets Mint 01)

    Premier Value Extra Strength Antacid Tablets (Rolaids Regular Strength Tablets Mint 01)

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