Antacid
FDA Label NDC 64725-1258

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tya Pharmaceuticals for the product Antacid (NDC 64725-1258). 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 (in each tablet), purpose, uses, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Calcium carbonate USP 500mg

Purpose

Antacid

Uses

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms

Ask A Doctor Before Use If You Have

  • kidney stones
  • a calcium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are

  • now 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
  • do not use the maximum dosage for more than 2 weeks

Directions

  • chew 2 - 4 tablets as symptoms occur, or as directed by a doctor

Other Information

  • each tablet contains: calcium 215 mg and magnesium 5 mg
  • store at 20-25°C (68-77°F)

Inactive Ingredients

adipic acid, blue #1 aluminum lake, dextrose, flavors, maltodextrin, mineral oil, polyethylene glycol, powdered cellulose, red #40 aluminum lake, talc, yellow #5 aluminum lake (tartrazine), yellow #6 aluminum lake

Questions?

1-800-616-2471

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