Quality Choice Tablet, Chewable
FDA Label NDC 83324-314

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Assoiciation) for the product Quality Choice (NDC 83324-314). 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.

Active Ingredient (Per Tablet)

Calcium Carbonate USP 1000mg

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 7 tablets in 24 hours
  • if pregnant do not take more than 5 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 2-3 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: calcium 400 mg
  • 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 Lake, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, flavors, FD&C Yellow No. 6 Lake, magnesium stearate, maltodextrin, starch, sucralose,

Questions Or Comments?

1-866-467-2748

Package/Label Principal Display Panel

*Compare to the active ingredient in Ultra Strength Tums®

NDC 83324-314-72

QUALITY CHOICE

Ultra Strength

Antacid Tablets

Calcium Carbonate 1000 mg

Relieves:

Upset Stomach

Heartburn

Acid Indigestion

Assorted Fruit

72 Chewable Tablets

K PAREVE

GLUTEN- FREE

QC SATISFACTION GURANTEED

Distributed by C.D.M.A., Inc.

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

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

Quality Choice Ultra Strength Antacid 72 Chewable Tablets (103af72pvlflb)

Quality Choice Ultra Strength Antacid 72 Chewable Tablets (103af72pvlflb)

* Please review the disclaimer below.