Ultra Strength Tablet, Chewable
FDA Label NDC 68196-103

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sam's West Inc for the product Ultra Strength (NDC 68196-103). 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, ask a doctor or pharmacist before use if you are, when using this product, directions, other information, inactive ingredients, 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

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 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: elemental calcium 400mg
  • Store at room temperature

Inactive Ingredients

adipic acid, blue 1 lake, dextrose, flavors, magnesium stearate, red 40 lake, starch, sucralose.

Questions Or Comments?

1-888-301-0332

Safety Sealed:

Do not use if printed seal under cap is torn or missing

Package/Label Principal Display Panel

Member’s Mark™

COMPARE TO TUMS® Ultra Strength active ingredient*

ULTRA STRENGTH 1000

ANTACID TABLETS

Calcium Carbonate

Assorted Berry Flavors

Naturally and Artificially Flavored

GLUTEN FREE

K PAREVE

DISTRIBUTED BY SAM’S WEST, INC.

BENTONVILLE, AR 72716

For comments or suggestions, call us toll-free at 1.888-301-0332 from 8 a.m. to 5 p.m. CST Monday-Friday

*This product is not manufactured or distributed by GlaxoSmithKline, the distributor of Tums®.

Package Label 265 Chewable Tablets

* Please review the disclaimer below.