Regular Strength Tablet, Chewable
FDA Label NDC 71399-9939

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akron Pharma Inc for the product Regular Strength (NDC 71399-9939). 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, uses, warnings, otc - keep out of reach of children, directions, 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

Calcium Carbonate USP 500mg

Purpose

Antacid

Uses

relieves:

• heartburn

• sour stomach

• acid indigestion

• upset stomach associated with these symptoms

Warnings

Ask a doctor or pharmacist before use if you are presentlytaking 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.

Otc - Keep Out Of Reach Of Children

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 doctor.
  • Do not swallow tablets whole,
  • Do 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 at room temperature. Keep the container tightly closed

    • Safety sealed: Do not use if printed seal under cap is torn or missing.

Inactive Ingredients

adipic acid, D&C Red No.27 lake, D&C Yellow No.10 lake, dextrose, FD&C Blue No.1 lake, FD&C Yellow No.6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

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