LEADER EXTRA STRENGTH ANTACID- calcium carbonate tablet, chewable 
CARDINAL HEALTH 110, LLC. DBA LEADER

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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Leader Extra Strength Antacid Tropical Fruit Chewable Tablets

ACTIVE INGREDIENT (in each tablet)

Calcium carbonate 750 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 10 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

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

PRINCIPAL DISPLAY PANEL

LEADER
NDC 70000-0431-1
Extra Strength
Antacid Tablets

Calcium Carbonate 750 mg
Tropical Fruit Flavor
COMPARE TO TUMS® EXTRA STRENGTH active ingredient*

Relief of :


96 CHEWABLE TABLETS



117
LEADER EXTRA STRENGTH ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0431
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 2S7830E561)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorORANGE, YELLOW, PINK (reddish pink) Scoreno score
ShapeROUNDSize16mm
FlavorBANANA, ORANGE, PLUM (punch) Imprint Code G127
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0431-196 in 1 BOTTLE; Type 0: Not a Combination Product07/17/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33107/17/2019
Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(70000-0431)

Revised: 1/2022
Document Id: cd0ebfdf-92db-4b86-ab32-77d00f643c96
Set id: 81911f6d-7edf-4183-9720-2f20a5db498d
Version: 3
Effective Time: 20220110
 
CARDINAL HEALTH 110, LLC. DBA LEADER