CALCIUM ANTACID- calcium antacid tablet, chewable 
Sunmark

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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SUNMARK CALCIUM ANTACID

Active ingredient (in each tablet)

Calcium carbonate 750 mg


Purpose

Antacid


Uses

relieves

  • acid indigestion
  • heartburn

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
  • do not use if printed seal under cap is torn or missing.
  • store at room temperature.

Inactive ingredients

adipic acid, corn starch, crospovidone, DC red 27 lake, DC red 30 lake, DC yellow 10 lake, dextrose, FDC blue 1 lake, FDC yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc

Principal Display Panel

COMPARE TO TUMS® E-X ACTIVE INGREDIENT

calcium antacid

Extra Strength

Fast relief of heartburn and acid indigestion

Daily source of calcium

ASSORTED FRUITAssorted fruit anatcid front label Assorted fruit antacid back label

CALCIUM ANTACID 
calcium antacid tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-954
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)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 2S7830E561)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
DEXTROSE (UNII: IY9XDZ35W2)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
Colorpink (Reddish pink) , orange, yellow, greenScoreno score
ShapeROUNDSize16mm
FlavorFRUIT (lemon, lime, cherry, orange) Imprint Code G127
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-954-3496 in 1 BOTTLE; Type 0: Not a Combination Product04/07/201112/10/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33104/07/201112/10/2018
Labeler - Sunmark (177667227)

Revised: 12/2018
Document Id: 0ad82539-5a6b-4b3c-8f5d-24c15f3a2faa
Set id: 89b39f33-6324-4ab1-89b8-4e6e0a587c4f
Version: 4
Effective Time: 20181210
 
Sunmark