SUNMARK SMOOTH ANTACID  - calcium carbonate tablet, chewable 
McKesson

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.

----------

Sunmark Smooth Antacid Extra Strength

Active ingredient (in each tablet)

Calcium carbonate 750 mg

Purpose

Antacid

Uses

relieves:


Warnings


Ask a doctor or pharmacist before use if you are

taking a prescription drug. Antacids may interact with certain prescription drugs.

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.

Keep out of reach of children

Directions

chew 2-4 tablets as symptoms occur, or as directed by a doctor

Other information

Inactive ingredients

adipic acid, blue 1, corn starch, dextrose, flavors, magnesium stearate, maltodextrin, microcrystalline cellulose, red 40, red 30, sorbitol, sucrose, talc, yellow 6, yellow 10

PDP

sunmark

COMPARE TO TUMS® SMOOTH DISSOLVE E-X ACTIVE INGREDIENT

smooth antacid

Extra Strength

Fast  relief  of heartburn and acid  indigestion

Daily source of  calcium

ASSORTED FRUIT FLAVORS
90 CHEWABLE TABLETS
SMOOTH ANTACID FRONT LABEL
SMOOTH ANTACID BACK LABEL


SUNMARK SMOOTH ANTACID  
calcium carbonate tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-632
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB, CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
Inactive Ingredients
Ingredient NameStrength
ADIPIC ACID (UNII: 76A0JE0FKJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STARCH, CORN (UNII: O8232NY3SJ)  
SORBITOL (UNII: 506T60A25R)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
Colorpink (bluish pink) , yellow, orange, pinkScoreno score
ShapeROUNDSize19mm
FlavorFRUIT (Cherry, Lemon, Orange, Strawberry) Imprint Code G173
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-632-1390 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33104/26/2004
Labeler - McKesson (177667227)

Revised: 10/2012
Document Id: 98d0f85c-b530-46b9-bd32-4becd65eebbe
Set id: ce0e3637-b5f2-43c8-80d9-dc00aa09d5c7
Version: 1
Effective Time: 20121016
 
McKesson