EXTRA STRENGTH SMOOTH ANTACID - calcium carbonate tablet, chewable 
Thirty Madison Inc

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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Extra Strength Smooth Antacid Chill Berries

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 BREAST FEEDING,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

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

PRINCIPAL DISPLAY PANEL

Extra Strength
Smooth
Antacid Tablets
evens
Chill Berries 
Calcium Carbonate 750 mg

60 Chewable Tablets

Compare to the active ingredient  in TUMS®SmoothiesTM EX



44

EXTRA STRENGTH SMOOTH ANTACID 
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71713-204
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)  
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)  
SORBITOL (UNII: 506T60A25R)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorRED (light red) , BLUE (light blue) , PINK (light pink) Scoreno score
ShapeROUNDSize16mm
FlavorBERRY (STRAWBERRY, RASPBERRY, WIDBERRY) , CHERRYImprint Code G173
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71713-204-0360 in 1 BOTTLE; Type 0: Not a Combination Product05/17/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33105/17/2019
Labeler - Thirty Madison Inc (080774087)

Revised: 1/2022
Document Id: 966f739d-4d4c-40aa-add8-430fa7f3654f
Set id: 95fcaed0-b761-4e6e-a1a6-184dc3ba0548
Version: 3
Effective Time: 20220106
 
Thirty Madison Inc