Extra Strength Sugar Free
FDA Label NDC 68163-202

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Raritan Pharmaceuticals Inc for the product Extra Strength Sugar Free (NDC 68163-202). 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 750 mg

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 9 tablets in 24 hours
  • If pregnant do not take more than 6 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 300 mg
  • store below 30°C (86°F).

Inactive Ingredients

adipic acid, flavors, magnesium stearate, maltodextrin, sorbitol, starch, sucralose, FD&C Yellow No. 6 lake.

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

NDC 68163-202-90

DRxCHOICE®

COMPARE TO TUMS® active ingredient*

EXTRA STRENGTH

Antacid

Tablets

Calcium Carbonate USP 750 mg

Sugar-Free

  •  Relieves:
    • Acid Indigestion
    • Sour Stomach
    • Heartburn
    •  Orange Cream Flavor
    •  Naturally and Artificially Flavored
    •  GLUTEN FREE

      • 90 CHEWABLE TABLETS

      K PARVE

      Distributed by:

      Raritan Pharmaceuticals

      8 Joanna Court, East Brunswick, NJ 08816

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

      Drxchoice Extra Strength Calcium Carbonate 90 Chewable Tablets (102ab96pvlflb)

      Drxchoice Extra Strength Calcium Carbonate 90 Chewable Tablets (102ab96pvlflb)

* Please review the disclaimer below.