ANTACID - calcium carbonate tablet, chewable 
Kinray Inc.

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 Antacid Tablets

Active Ingredient

(in each chewable tablet)

Calcium Carbonate 500 mg

Purpose

Antacid

Uses

relieves

Warnings

Ask a doctor before use if you have

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Inactive Ingredients

Al-lakes (D&C red #27, D&C yellow # 10, FD&C blue #1, FD&C yellow # 6), dextrose, flavors (cherry, lemon, lime, orange), magnesium stearate, maltodextrin

Questions or Comments

Call 631-981-4600, Monday-Friday, 8.30 am – 4.30 pm ET

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Calcium Carbonate 500 mg

Antacid tablets

NDC: 61715-058-54 – 150 COUNT

ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-058
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
DEXTROSE (UNII: IY9XDZ35W2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
CHERRY (UNII: BUC5I9595W)  
LEMON (UNII: 24RS0A988O)  
ORANGE (UNII: 5EVU04N5QU)  
Product Characteristics
ColorYELLOW, PINK, GREENScorescore with uneven pieces
ShapeROUNDSize16mm
FlavorLIME (Cherry,Lemon,Orange) Imprint Code AP;043
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-058-54150 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33106/28/2013
Labeler - Kinray Inc. (012574513)
Registrant - Advance Pharmaceutical Inc. (078301063)
Establishment
NameAddressID/FEIBusiness Operations
Advance Pharmaceutical Inc.078301063MANUFACTURE(61715-058)

Revised: 7/2013
Document Id: c6eab715-b3a3-40af-bc77-8d3c0c99e007
Set id: 83692fe0-d7c2-42b7-aadf-e73b20912e5c
Version: 1
Effective Time: 20130702
 
Kinray Inc.