CALCIUM CARBONATE ASSORTED FLAVORS- antacid tablets 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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Major Regular Strength Antacid 150 Chewable Tablets

Active ingredient

Calcium Carbonate USP 500mg

Purpose

Antacid

Uses

relieves:

• heartburn

• sour stomach

• acid indigestion

• upset stomach associated with these symptoms

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

Safety sealed: Do not use if printed seal under cap is torn or missing.

Inactive ingredients

adipic acid, D&C Red No. 27 Lake, D&C Yellow No. 10 Lake, dextrose, FD&C Blue No. 1 Lake, FD&C Yellow No. 6 Lake, flavors, magnesium stearate, maltodextrin, starch, sucralose.

Package/Label Principal Display Panel

pdp

CALCIUM CARBONATE  ASSORTED FLAVORS
antacid tablets tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-2258(NDC:0904-6412)
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)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
STARCH, CORN (UNII: O8232NY3SJ)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize16mm
FlavorFRUITImprint Code RP101
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-2258-5150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33108/12/2014
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300relabel(68071-2258)

Revised: 1/2022
Document Id: d606e5ed-42da-2a74-e053-2a95a90a4a6f
Set id: af10dfb6-fef3-3410-e053-2995a90a9130
Version: 2
Effective Time: 20220120
 
NuCare Pharmaceuticals,Inc.