GOODSENSE EXTRA STRENGTH ANTACID - calcium carbonate tablet, chewable 
GoodSense

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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GoodSense Extra Strength Antacid Assorted Berry 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

adipic acid, corn starch, crospovidone, dextrose, FD&C blue 1 lake, FD&C red 40 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc.

PRINCIPAL DISPLAY PANEL

GOODSENSE
Extra Strength
NDC 50804-129-22

Antacid 

Tablets
Calcium Carbonate 750 mg
Antacid
Fast Relief of :

Assorted Berry Flavors
Compare to  active ingredient of Extra Strength Tums®* 
96 CHEWABLE TABLETS



127AB
GOODSENSE EXTRA STRENGTH ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-129
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
ADIPIC ACID (UNII: 76A0JE0FKJ)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorBLUE, PINK, PINK (PINKISH BLUE) Scoreno score
ShapeROUNDSize16mm
FlavorBERRY (STRAWBERRY, RASPBERRY, WIDBERRY) Imprint Code G127
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50804-129-2296 in 1 BOTTLE; Type 0: Not a Combination Product08/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33108/30/2018
Labeler - GoodSense (076059836)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(50804-129)

Revised: 11/2018
Document Id: 2fcdeb06-17de-49d8-97bb-8d31e1c0c61f
Set id: 2fcdeb06-17de-49d8-97bb-8d31e1c0c61f
Version: 1
Effective Time: 20181121
 
GoodSense