Regular Strength Antacid Tablet, Chewable
FDA Label NDC 70000-0034

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Regular Strength Antacid (NDC 70000-0034). 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, purpose, uses, warnings, directions, other information, inactive ingredients, package/label principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Calcium Carbonate USP 500mg

Purpose

Antacid

Uses

relieves:

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

Warnings

Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

  • do not take more than 15 tablets in 24 hours
  • if pregnant do not take more than 10 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 tablets contains: elemental calcium 200mg
  • 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, D&C Red No. 27, D&C Yellow No. 10, dextrose, FD&C Blue No. 1, flavors, magnesium stearate, maltodextrin, starch, sucralose.

Package/Label Principal Display Panel

NDC 70000-0034-1

COMPARE TO TUMS® REGULAR STRENGTH active ingredient*

Regular Strength

Antacid Tablets

Calcium Carbonate 500mg

Assorted Fruit Flavor

Naturally and Artificially Flavored

Relieves:

Upset Stomach

Heartburn

Acid Indigestion

100% Money Back Guarantee

150 Chewable Tablets

©2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinals Health.

All other marks are the property of their respective owners.

www.myleader.com

DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017

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

Cardinal Regular Strength Assorted Fruit Antacid Tablets (C1171d19 5694 4e6c 9865 40c5f62c4f05 01)

Cardinal Regular Strength Assorted Fruit Antacid Tablets (C1171d19 5694 4e6c 9865 40c5f62c4f05 01)

Cardinal Regular Strength Antacid Tablets

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