Calcium Carbonate
FDA Label NDC 81646-112

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pinnacle Pharma Llc for the product Calcium Carbonate (NDC 81646-112). 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 5 ml teaspoonful), purpose, uses, directions, other information, inactive ingredients, questions or comments?, principal display panel - 5 ml cup tray label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each 5 Ml Teaspoonful)

→ Purpose

→ Uses

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 5 Ml Cup Tray Label

Active Ingredient (In Each 5 Ml Teaspoonful)

Calcium Carbonate 1250 mg
(Equivalent to 500 mg elemental Calcium)

Purpose

Antacid

Uses

Relieves:

heartburn
acid indigestion
sour stomach
upset stomach associated with these symptoms

Directions

Shake well before using.
Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.

Other Information

store at 20° - 25°C (68° - 77°F)
do not freeze
Calcium Carbonate Oral Suspension is a pink-colored, bubble gum flavored suspension supplied in the following oral dosage forms:

NDC 0121-0766-16:	16 fl oz (473 mL) bottle
NDC 0121-4766-05:	5 mL unit dose cup, in a tray of ten cups.

Inactive Ingredients

calcium saccharin, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol and xanthan gum.