CALCIUM CARBONATE 500 MG- calcium carbonate tablet, chewable 
NuCare Pharmaceuticals,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 Carbonate 500 mg

Drug Facts

Active ingredient (in each chewable tablet)

Calcium carbonate 500 mg

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.

Stop use and ask a doctor if symptoms last more than 2 weeks

Keep out of reach of children.

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

Stop use and ask doctor if symptoms last more than 2 weeks

Keep out of reach of children.

Directions

Adults and children 12 years and over:

children under 12 years:

ask a doctor

Other information

Inactive ingredients

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

Questions or comments?

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday-Friday

PDP

CALCIUM CARBONATE 500 MG 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-2345(NDC:69618-020)
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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
DEXTROSE (UNII: IY9XDZ35W2)  
Product Characteristics
Colorblue (Light Blue) , orange (Light Orange) , yellow (Light Yellow) , purple (Light Purple) Scoreno score
ShapeROUNDSize16mm
FlavorORANGE (assorted fruit) Imprint Code AP;043
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-2345-5150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/08/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33111/01/2015
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300relabel(68071-2345)

Revised: 2/2021
Document Id: bad70158-3891-7e98-e053-2995a90a9c1c
Set id: bad70158-3890-7e98-e053-2995a90a9c1c
Version: 1
Effective Time: 20210208
 
NuCare Pharmaceuticals,Inc.