Calcium Carbonate
FDA Label NDC 16103-377

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharbest Pharmaceuticals Inc. for the product Calcium Carbonate (NDC 16103-377). 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 or pharmacist before use if, if pregnant or nursing a baby,, direction, other information, inactive ingredients, 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 10 gr (648 mg, USP)

Purpose

Antacid

Uses

for relief of

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

Ask A Doctor Or Pharmacist Before Use If

you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

If Pregnant Or Nursing A Baby,

ask a health professional before use.

Direction

  • take one to four tablets daily
  • do not take more than 4 tablets in a 24 hour period
  • do not use the maximum dosage for more than 2 weeks 

Other Information

  • each tablet contains: calcium 260 mg
  • store at controlled room temperature 150 to 300c (590 to 860F)
  • use by expiration date on package

Inactive Ingredients

microcrystalline cellulose, croscarmellose sodium, stearic acid, magnesium stearate

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