Topcare Antacid Calcium Tablet, Chewable
FDA Label NDC 36800-478

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc. for the product Topcare Antacid Calcium (NDC 36800-478). 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 500mg

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 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 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 200mg
    • store at room temperature. Keep the container tightly closed.

Inactive Ingredients

adipic acid, D & C red # 27 lake, D&C yellow # 10 lake, dextrose, FD&C blue #1 lake, FD&C yellow #6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

Questions?

1-888-423-0139

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

Package/Label Principal Display Panel

NDC # 36800-478-48

+ TopCare ® health TM

COMPARE TO REGULAR STRENGTH TUMS® ACTIVE INGREDIENT*

Regular Strength

Antacid

Calcium Carbonate

FAST RELIEF OF:

  • Upset Stomach
  • Heartburn
  • Acid indigestion

    • ASSORTED FRUIT FLAVORS

    500 mg

    150 CHEWABLE TABLETS

    GLUTEN- FREE

    QUALITY GUARANTEED

    For questions or comments, please call

    1-888-423-0139.

    Distributed by: TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 6007

    © TOPCO RARA0918

    QUESTIONS? 1-888-423-0139

    [email protected]www.topcarebrand.com

    Visit here for more information: http://topbrnds.com/48ZS0K

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

    Topcare Regular Strength Antacid Calcium Carbonate Assorted Fruit Flavors (103af72pvlflb)

    Topcare Regular Strength Antacid Calcium Carbonate Assorted Fruit Flavors (103af72pvlflb)

* Please review the disclaimer below.