TOPCARE ULTRA STRENGTH ANTACID ASSORTED FRUIT - calcium carbonate tablet, chewable 
Topco Associates, 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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TopCare Ultra Strength Antacid Assorted Fruit

ACTIVE INGREDIENT (in each tablet)

Calcium carbonate 1000 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 7 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

TopCare® health

NDC 76162-129-68
COMPARE TO TUMS® ULTRA STRENGTH ACTIVE INGREDIENT*

ULTRA STRENGTH
Antacid Tablets
CALCIUM CARBONATE

1000 mg


RELIEVES:

ASSORTED FRUIT FLAVORS


72 CHEWABLE TABLETS



171-72



TOPCARE ULTRA STRENGTH ANTACID ASSORTED FRUIT 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-129
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE1000 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--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
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
ShapeROUNDSize17mm
FlavorCHERRY, LEMON, LIME, ORANGEImprint Code G171
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-129-6872 in 1 BOTTLE; Type 0: Not a Combination Product04/26/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33104/26/2022
Labeler - Topco Associates, LLC (006935977)

Revised: 4/2022
Document Id: dd038b15-2ecb-4ee2-b356-db6d87c2f01b
Set id: dd038b15-2ecb-4ee2-b356-db6d87c2f01b
Version: 1
Effective Time: 20220426
 
Topco Associates, LLC