Calcium Carbonate Suspension
FDA Label NDC 0121-0766

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pai Holdings, Llc Dba Pai Pharma for the product Calcium Carbonate (NDC 0121-0766). 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 other, active ingredient (in each 5 ml teaspoonful), purpose, uses, otc - ask doctor/pharmacist, otc - when using, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

When using this product, do not take more than 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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° to 25°C (68° to 77°F)
  • do not freeze
  • packaged with tamper evident seal

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.

Questions?

Call 1-800-845-8210.

Principal Display Panel - 473 Ml Bottle Label

NDC 0121-0766-16

Quality®
Value

Calcium Carbonate
Oral Suspension

1250 mg/5 mL

Maximum Strength
ANTACID

Daily source of calcium

SUGAR FREE / ALCOHOL FREE
SODIUM FREE

16 fl oz (473 mL)

pai
Pharmaceutical
Associates, Inc.
Greenville, SC 29605

Principal Display Panel - 5 Ml Cup Label

Delivers 5 mL
NDC 0121-4766-05

CALCIUM CARBONATE
ORAL SUSPENSION
1250 mg/5 mL
(equivalent to 500 mg
of elemental Calcium)

ANTACID - SHAKE WELL

FOR INSTITUTIONAL USE ONLY
 PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT

A47660500

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