GUARDIAN EXTRA STRENGTH ANTACID - calcium carbonate tablet, chewable 
Guardian Drug Company

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.

----------

Guardian Extra Strength Alkums Antacid Wintergreen 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 yellow 10 lake, dextrose, FD&C blue 1 lake, flavor, magnesium stearate, maltodextrin, sucrose, talc.

PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Tums® EX

Guardian®

NDC53041-130-22
Extra Strength


Alkums Antacid Tablets

Wintergreen Flavor
Calcium Carbonate 750 mg

Relieves:


96 CHEWABLE TABLETS

127WG-96

GUARDIAN EXTRA STRENGTH ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-130
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)  
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 YELLOW NO. 10 (UNII: 35SW5USQ3G)  
CROSPOVIDONE (UNII: 68401960MK)  
Product Characteristics
ColorGREENScoreno score
ShapeROUNDSize16mm
FlavorWINTERGREEN (wintergreen) Imprint Code G127
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53041-130-2296 in 1 BOTTLE; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33105/02/2022
Labeler - Guardian Drug Company (119210276)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(53041-130)

Revised: 4/2022
Document Id: df7c4a87-1090-4327-b7de-b40f9a4f891f
Set id: aef3d830-c5c3-4f72-86ba-d31945a756db
Version: 2
Effective Time: 20220408
 
Guardian Drug Company