Extra Strength Tablet, Chewable
FDA Label NDC 68391-102

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bjwc for the product Extra Strength (NDC 68391-102). 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 (per tablet), purpose, uses, ask a doctor or pharmacist before use if you are, when using this product, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (Per Tablet)

Calcium Carbonate USP 750mg

Purpose

Antacid

Uses

relieves

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

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

  • do not take more than 10 tablets in 24 hours
  • if pregnant do not take more than 6 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Directions

  • adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.
  • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Other Information

  • each tablet contains: elemental calcium 300mg
  • store at room temperature. Keep the container tightly closed.

Inactive Ingredients

adipic acid, dextrose, FD&C blue #1 lake, FD&C red # 40 lake, flavor, magnesium stearate, maltodextrin, starch, sucralose.

Questions Or Comments?

1-866-467-2748

Safety Sealed

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Package/Label Principal Display Panel

berkley jensen®

NDC# 68391-102-00

**Compare to the active ingredient in Tums® Extra Strength

Extra Strength

Antacid Tablets

Assorted Berry Flavors

FAST RELIEF OF:

  • Acid Indigestion
  • Upset Stomach
  • Heartburn

    • 200 CHEWABLE TABLETS

    K PAREVE

    Every Berkley Jensen product comes with our

    100% Money-Back Guarantee.

    Distributed by:

    BJ’S Wholesale Club,

    25 Research Drive,

    Westborough, MA 01581.

    Questions? 1-800-934-1204

    Made in USA

    *This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Extra Strength Tums®.

* Please review the disclaimer below.