Extra Strength Tablet, Chewable
FDA Label NDC 21130-201

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands, Llc for the product Extra Strength (NDC 21130-201). 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?, 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 completely as symptoms occur, or as directed by a doctor. Do not swallow tablets whole.
  • 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.
  •  Safety sealed: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
  •  

Inactive Ingredients

adipic acid, dextrose, FD&C Blue No. 1 Lake, FD&C Red No. 40 Lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

Questions?

1-866-467-2748

Package/Label Principal Display Panel

NDC # 21130-201-96

*Compare to active ingredient in Extra Strength Tums®

EXTRA STRENGTH

Antacid Tablets

Calcium Carbonate 750 mg

Fast Relief of Upset

Stomach, Heartburn & Acid Indigestion

Assorted Berries

Naturally & Artificially Flavored

96 Chewable Tablets

GLUTEN- FREE

K PAREVE

Distributed by:

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

Package Label for 96 Chewable Tablets

Extra Strength Antacid 96 Chewable Tablets (103af72pvlflb)

Extra Strength Antacid 96 Chewable Tablets (103af72pvlflb)

* Please review the disclaimer below.