Calcium Carbonate Powder
FDA Label NDC 0395-0431

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Humco Holding Group, Inc. for the product Calcium Carbonate (NDC 0395-0431). 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, ask a doctor before use, keep out of reach of children., directions, 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

Purpose

Antacid

Use

For relief of heartburn, acid ingestion, and upset stomach associated with these symptoms.

Warnings

Except under the supervision of a doctor:

  • do not administer to children under 6 years of age.
  • do not take more than 3 teaspoonfuls in a 24 hour period.

Ask A Doctor Before Use

if you are preganant or nursing a baby.

Keep Out Of Reach Of Children.

In case of accidental overdose, seek professional assistance or contact a Poison Control immediately.

Directions

Adults and children 6 yrs. of age and older: Take 1/2 level tsp. in 1/2 glass (4 fl oz) of water every 2 hrs. up to maximum dosage or as directed by a doctor.

Inactive Ingredients

None

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