Fast Acting Heartburn Relief Tablet, Chewable
FDA Label NDC 68163-011

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 Fast Acting Heartburn Relief (NDC 68163-011). 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 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 older: 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

Gum acacia, magnesium stearate, microcrystalline cellulose, natural peppermint oil, polyplasdone, sucrose.

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 68163-011-00

*COMPARE TO THE ACTIVE INGREDIENT IN REGULAR STRENGTH TUM®

FAST ACTING

HEARTBURN RELIEF

FOR FAST RELIEF OF:

ACID INDIGESTION, SOUR STOMACH & HEATBURN

PEPPERMINT FLAVOR

GLUTEN FREE

100 CHEWABLE TABLETS

KOSHER FOR PASSOVER

This product does not contain any Chometz or Kitnius

This product contains no animal soybean, or grain derivatives.

Manufactured for: Adwe Laboratories

1274 49 Street, Brooklyn, NY 11219

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

Fast Acting Heartburn Relief Antacid 100 Chewable Tablets (101ppt150pvlflb)

Fast Acting Heartburn Relief Antacid 100 Chewable Tablets (101ppt150pvlflb)

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