CAREONE REGULAR STRENGTH CALCIUM ANTACID - calcium carbonate tablet, chewable 
Retail Business Services, LLC.

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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Regular Strength Calcium Antacid Assorted Fruit

ACTIVE INGREDIENT (in each tablet)

Calcium carbonate 500 mg

PURPOSE

Antacid

USE(S)

relieves:

WARNINGS

.

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

WHEN USING THIS PRODUCT

do not take more than 15 tablets in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

IF PREGNANT OR/BREASTFEEDING,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

PRINCIPAL DISPLAY PANEL

NDC 72476-026-17

CAREone

Compare to the active ingredient in Tums® Regular Strength 500 Assorted Fruit*

REGULAR STRENGTH

CALCIUM ANTACID 
Calcium Carbonate 500 mg

Assorted Fruit Flavors


Fast relief of Heartburn and Acid Indigestion


Gluten Free


150 CHEWABLE TABLETS

101

CAREONE REGULAR STRENGTH CALCIUM ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-026
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)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 2S7830E561)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorORANGE, YELLOW, GREEN, PINK (reddish pink) Scoreno score
ShapeROUNDSize16mm
FlavorCHERRY, LEMON, LIME, ORANGEImprint Code G126
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-026-17150 in 1 BOTTLE; Type 0: Not a Combination Product10/13/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33110/13/2021
Labeler - Retail Business Services, LLC. (967989935)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(72476-026)

Revised: 8/2021
Document Id: cb6e12cc-4b88-4046-a9fc-2dbe4bca965e
Set id: cb6e12cc-4b88-4046-a9fc-2dbe4bca965e
Version: 1
Effective Time: 20210831
 
Retail Business Services, LLC.