Ultra Strength Tablet, Chewable
FDA Label NDC 21130-310

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 Ultra Strength (NDC 21130-310). 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.

Label Section Quick Index

Active Ingredient (Per Tablet)

Calcium Carbonate USP 1,000mg

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 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. Keep the container tightly closed

Inactive Ingredients

adipic acid, D&C Red No. 27 Lake, D&C Yellow No.10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Yellow No. 6, flavor, magnesium stearate, maltodextrin, starch, sucralose.

Questions Or Comments?

1-866-467-2748

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

Package/Label Principal Display Panel

*Compare to the active ingredients in Ultra Strength Tums®

ULTRA STRENGTH

Antacid Tablets

Calcium Carbonate 1000mg

Relieves of:

  • Acid indigestion
  • Sour Stomach
  • Heartburn

    • Assorted Fruit Flavors

    GLUTEN-FREE

    Distributed by:

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

    Package Label 160 Chewable Tablets

    Ultra Strength Antacid Assorted Fruit 160 Ct (102ab96pvlflb)

    Ultra Strength Antacid Assorted Fruit 160 Ct (102ab96pvlflb)

* Please review the disclaimer below.