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Calcium Carbonate by Pharmaceutical Associates, Inc.

Medically reviewed on September 15, 2017

Dosage form: suspension
Ingredients: Calcium Carbonate 1250mg in 5mL
Labeler: Pharmaceutical Associates, Inc.
NDC Code: 0121-0766

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Calcium Carbonate

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

Warnings

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

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.

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

CALCIUM CARBONATE 
calcium carbonate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0766
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium Carbonate (Calcium Cation and Carbonate Ion) Calcium Carbonate1250 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Propylparaben 
Methylparaben 
Propylene Glycol 
Sorbitol 
Glycerin 
Xanthan Gum 
Citric Acid Monohydrate 
FD&C Red No. 40 
D&C Red No. 33 
Saccharin Calcium 
Water 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-0766-1612 BOTTLE in 1 CASE
1473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33112/01/2004
CALCIUM CARBONATE 
calcium carbonate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-4766
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium Carbonate (Calcium Cation and Carbonate Ion) Calcium Carbonate1250 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Propylparaben 
Methylparaben 
Propylene Glycol 
Sorbitol 
Glycerin 
Xanthan Gum 
Citric Acid Monohydrate 
FD&C Red No. 40 
D&C Red No. 33 
Saccharin Calcium 
Water 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-4766-054 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
15 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33112/01/2004
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Associates, Inc.097630693MANUFACTURE(0121-0766, 0121-4766)

 
Pharmaceutical Associates, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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