CALCIUM CARBONATE CHEWABLE ANTACID- 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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Active ingredient (in each tablet)

Calcium Carbonate 500 mg

Purpose

Antacid

Uses

Warnings

Ask a doctor before use if you
• have kidney disease
• are taking prescription drugs; antacids may interact with certain prescription drugs

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

When using this product • do not use the maximum dosage for more than 2 weeks

If pregnant or breast feeding, ask a health professional before use.

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

Directions

• do not exceed recommended dose
• adults and children 12 years of age and older: chew 2-4 tablets as symptoms occur
• repeat hourly if symptoms return, or as directed by a physician
• do not take more than 15 tablets in a 24 hour period
• children under 12 years: consult a doctor

Other information

each tablet contains: calcium 200 mg
• store at room temperature
• for institutional use only
Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Inactive ingredients

assorted flavors, dextrose, D and C Yellow no. 10 lake, FD and C Blue no. 1 lake, FD and C Red no. 40 lake, FD and C Yellow no. 6 lake, magnesium stearate, maltodextrin. May also contain cellulose, FD and C Yellow no. 5 lake (tartrazine), stearic acid, sugar.

Package label

pdp

CALCIUM CARBONATE CHEWABLE ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4588(NDC:57896-763)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE500 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE (UNII: IY9XDZ35W2)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
Product Characteristics
Colorred, green, orange, yellowScoreno score
ShapeROUNDSize14mm
FlavorCHERRY, LIME, ORANGE, LEMONImprint Code AZ;024
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-4588-5150 in 1 BOTTLE; Type 0: Not a Combination Product10/05/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33101/01/2004
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300relabel(68071-4588)

Revised: 10/2019
Document Id: 94184196-9cab-8d15-e053-2a95a90abe61
Set id: 7782cdf0-361c-421d-e053-2a91aa0af366
Version: 3
Effective Time: 20191004
 
NuCare Pharmaceuticals,Inc.