ANTACID- calcium carbonate tablet, chewable 
TYA Pharmaceuticals

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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Major Pharmaceuticals Antacid Tablets Drug Facts

Active ingredient (in each tablet)

Calcium carbonate USP 500mg

Purpose

Antacid

Uses

relieves

Warnings

Ask a doctor before use if you have

  • kidney stones
  • a calcium-restricted diet

Ask a doctor or pharmacist before use if you are

  • now taking a prescription drug. Antacids may interact with certain prescription drugs.

When using this product

  • do not take more than 15 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks

Keep out of reach of children.

Directions

Other information

Inactive ingredients

adipic acid, blue #1 aluminum lake, dextrose, flavors, maltodextrin, mineral oil, polyethylene glycol, powdered cellulose, red #40 aluminum lake, talc, yellow #5 aluminum lake (tartrazine), yellow #6 aluminum lake

Questions?

1-800-616-2471

ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE

Label Image
ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64725-1258(NDC:0904-1258)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 mg
Inactive Ingredients
Ingredient NameStrength
ADIPIC ACID (UNII: 76A0JE0FKJ)  
DEXTROSE (UNII: IY9XDZ35W2)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorRED, YELLOW, GREEN, ORANGEScoreno score
ShapeROUNDSize17mm
FlavorFRUIT (Cherry, lemon, lime, orange) Imprint Code L478
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64725-1258-1150 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33108/07/1992
Labeler - TYA Pharmaceuticals (938389038)
Registrant - TYA Pharmaceuticals (938389038)
Establishment
NameAddressID/FEIBusiness Operations
TYA Pharmaceuticals938389038RELABEL(64725-1258) , REPACK(64725-1258)

Revised: 11/2011
Document Id: b1dfde1b-4727-42f6-8fd7-80590567f59a
Set id: e7d03962-0c3d-4bdc-b84b-a3db3202f828
Version: 2
Effective Time: 20111127
 
TYA Pharmaceuticals