EXTRA STRENGTH ANTACID- calcium carbonate tablet, chewable 
PuraCap Pharmaceutical LLC

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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Extra Strength Antacid Tablets

Active ingredient (per tablet)

Calcium Carbonate USP 750 mg

Purpose

Antacid

Uses

relieves

Warnings

Ask a doctor or pharmacist before use if you are

presently taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

Keep out of reach of children.

Directions

Other information

Inactive ingredients

dextrose, flavor (peppermint), maltodextrin, magnesium stearate

Questions or comments?

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PRINCIPAL DISPLAY PANEL

Extra Strength Antacid Tablets

30 Tablets   15 Pouches (2 Tablets per Pouch)

NDC 51013-323-54

CVSF38-00

CVSB38-00

EXTRA STRENGTH ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-323
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION750 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE (UNII: IY9XDZ35W2)  
PEPPERMINT (UNII: V95R5KMY2B)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize16mm
FlavorPEPPERMINTImprint Code AP;052
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51013-323-5415 in 1 CARTON12/13/2017
12 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33112/13/2017
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063manufacture(51013-323)

Revised: 12/2017
Document Id: 5f8ca325-03d7-4046-ad97-44e43e970a91
Set id: 80509620-a3d1-49d5-b2e3-bff61ef4583d
Version: 1
Effective Time: 20171213
 
PuraCap Pharmaceutical LLC