CALCIUM CARBONATE- calcium carbonate suspension 
Atlantic Biologicals Corps

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.

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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:

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

Other information

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.

CALCIUM CARBONATE SUSPENSION

image description
CALCIUM CARBONATE 
calcium carbonate suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-3117(NDC:0121-0766)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, Carbonate Ion - UNII:7UJQ5OPE7D) CALCIUM CARBONATE1250 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Propylparaben (UNII: Z8IX2SC1OH)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sorbitol (UNII: 506T60A25R)  
Glycerin (UNII: PDC6A3C0OX)  
Xanthan Gum (UNII: TTV12P4NEE)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
D&C Red No. 33 (UNII: 9DBA0SBB0L)  
Saccharin Calcium (UNII: 5101OP7P2I)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-3117-3 5 mL in 1 CUP; Type 0: Not a Combination Product01/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33112/01/2004
Labeler - Atlantic Biologicals Corps (047437707)
Establishment
NameAddressID/FEIBusiness Operations
Atlantic Biologicals Corps047437707RELABEL(17856-3117) , REPACK(17856-3117)

Revised: 1/2021
Document Id: dc297adc-9021-4fb6-b8b7-05571ca1bab4
Set id: 38654d22-2f8a-49d2-a1cd-06d341f11323
Version: 5
Effective Time: 20210128
 
Atlantic Biologicals Corps