Calcium Carbonate
FDA Label NDC 68151-0012

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Carilion Materials Management for the product Calcium Carbonate (NDC 68151-0012). 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, purpose, use, 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.

Active Ingredient

(in each tablet)

Calcium carbonate 10 gr (648 mg)

Purpose

Antacid

Use

relieves

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

Warnings

taking a prescription drug. Antacids may interact with certain prescription drugs. Ask a doctor or pharmacist before use if you are

symptoms last more than 2 weeks. Stop use and ask a doctor if

, ask a health professional before use. If pregnant or breast-feeding

Keep out of reach of children.

Directions

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

Other Information

  • Each tablet contains: calcium 260 mg
    • store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

croscarmellose sodium, magnesium sterate, maltodextrin, microcrystalline cellulose, stearic acid

Questions Or Comments

Call Monday – Friday, 9 am – 5 pm ET 1-800-645-2158,

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

This is a bulk pakage, dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

Mfd for: Rugby Laboratories,Inc

* Please review the disclaimer below.