Calcium Carbonate 500mg
FDA Label NDC 68210-5033

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Calcium Carbonate 500mg (NDC 68210-5033). 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) calcium carbonete usp 500 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, keep out of reach of children., directions adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctordo not take for symptoms that persist for more than 2 weeks unless advised by a doctor, 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 Carbonete Usp 500 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 14 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

Keep Out Of Reach Of Children.

Directions Adults And Children 12 Years Of Age And Over: Chew 2-4 Tablets As Symptoms Occur, Or As Directed By A Doctordo Not Take For Symptoms That Persist For More Than 2 Weeks Unless Advised By A Doctor

Other Information

  • each tablet contains: elemental calcium 200 mg
  • store between 20-25° C (68-77°)
  • contains FD&C Yello No. 5 (tartrazine) as a color additive

Inactive Ingredients Adipic Acid, Fd&C Blue No. 1 Lake, Fd&C Yellow 5 (Tartrazine), Fd&C Yellow 6, Fd&C Red No. 40, Flavors, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Sugar

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