GOODSENSE EXTRA STRENGTH ANTACID ASSORTED FRUIT - 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 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

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

GOODSENSE
NDC 50804-127-22
Extra Strength
Antacid Tablets

Calcium Carbonate, 750 mg

Fast Relief of :


Assorted Fruit Flavors
*Compare to active ingredient of Extra Strength Tums®

96 Chewable Tablets



120
GOODSENSE EXTRA STRENGTH ANTACID ASSORTED FRUIT 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-127
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 (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 G127
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50804-127-2296 in 1 BOTTLE; Type 0: Not a Combination Product08/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33108/08/2018
Labeler - GoodSense (076059836)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(50804-127)

Revised: 1/2022
Document Id: 27889481-d636-4c3d-b740-03c3cf066a0e
Set id: ae6270fc-0f8d-4bba-8f12-adba3f07f7c5
Version: 2
Effective Time: 20220111
 
GoodSense