Ultra Strength Tablet, Chewable
FDA Label NDC 49035-167

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores,inc., for the product Ultra Strength (NDC 49035-167). 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 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 400mg
  • store at room temperature. Keep the container tightly closed.

Inactive Ingredients

adipic acid, D&C Yellow No. 10 Lake, dextrose, FD&C Red No. 40 Lake, FD&C Yellow No. 6 Lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

Questions?

1-866-467-2748

SAFETY SEALED: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING.

Package/Label Principal Display Panel

NDC 49035-167-16

*Compare to the active ingredient in Ultra Strength Tums®

ULTRA STRENGTH

Antacid Tablets

Calcium Carbonate 1000 mg

Fast Relief of Upset Stomach, Heartburn and Acid Indigestion.

Tropical Fruit

Naturally and Artificially Flavored

160 CHEWABLE TABLETS

GLUTEN- FREE

Encapsulated or Tableted in the US from Imported or Domestic Ingredients.

Distributed by: Wal-Mart Stores, Inc.,

Bentonville, AR 72716

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

Ultra Strength Twin Pack 160 Chewable Tablets (103af72pvlflb)

Ultra Strength Twin Pack 160 Chewable Tablets (103af72pvlflb)

* Please review the disclaimer below.