Extra Strength Tablet, Chewable
FDA Label NDC 21130-203

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Extra Strength (NDC 21130-203). 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, warnings, directions, other information, inactive ingredients, questions or comments?, 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

Warnings

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: calcium 300mg
  • store at room temperature. Keep the container tightly closed.

Inactive Ingredients

adipic acid, D&C Red No. 27 Lake, D&C Yellow 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Yellow No. 6 Lake, flavors, 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

NDC 21130-203-96

*Compare to active ingredient in Extra Strength Tums®

Extra strength

Antacid Tablets

Calcium Carbonate 750 mg

Fast Relief of Upset Stomach, Heartburn and Acid Indigestion

Assorted Fruit

Naturally and Artificially Flavored

96 Chewable Tablets

K PAREVE

GLUTEN FREE

Distributed by:

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

Extra Strength Antacid Assorted Fruit 96 Chewable Tablets (102af96pvlflb)

Extra Strength Antacid Assorted Fruit 96 Chewable Tablets (102af96pvlflb)

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