SUNMARK SMOOTH ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [MCKESSON]

SUNMARK SMOOTH ANTACID (CALCIUM CARBONATE) TABLET, CHEWABLE [MCKESSON]
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NDC 49348-632-13
Set ID ce0e3637-b5f2-43c8-80d9-dc00aa09d5c7
Category HUMAN OTC DRUG LABEL
Packager McKesson
Generic Name
Product Class
Product Number
Application Number PART331
  • Active ingredient (in each tablet)

    Calcium carbonate 750 mg

  • Purpose

    Antacid

  • Uses

    relieves:
    • acid indigestion
    • heartburn
  • KEEP OUT OF REACH OF CHILDREN


  • 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 pull tab seal under cap is torn or missing
    • store at room temperature
  • 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


  • INGREDIENTS AND APPEARANCE
    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)