Label: ANTACID EXTRA STRENGTH ASSORTED FRUIT- calcium antacid tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated January 14, 2022

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  • Active ingredient (in each tablet)

    Calcium carbonate 750 mg


  • Purpose

    Antacid

  • KEEP OUT OF REACH OF CHILDREN


  • Uses

    relieves

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
  • 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

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

    Other information

    • each tablet contains: elemental calcium 300 mg
    • do not use if carton is open or individual roll foil wrapping is damaged.
    • store at room temperature.
  • Inactive ingredients

    adipic acid, corn starch, crospovidone, D&C red 27 lake, D&C red 30 lake, D&C yellow 10 lake, dextrose, FD&C blue 1 lake, FD&C yellow 6 lake, flavors, magnesium stearate, maltodextrin, sucrose, talc

  • PRINCIPAL DISPLAY PANEL

    *Compare to the active ingredient in TUMS® Extra Strength

    Antacid Extra Strength

    CALCIUM CARBONATE 750 mg / ANTACID

    Relieves: Acid Indigestion & Heartburn

    Assorted Fruit

    Naturally & Artificially Flavored

    24 Chewable Tablets

    image description

  • INGREDIENTS AND APPEARANCE
    ANTACID EXTRA STRENGTH ASSORTED FRUIT 
    calcium antacid tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-229
    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, UNSPECIFIED FORM (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:67091-229-083 in 1 CARTON12/12/2014
    18 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33112/12/2014
    Labeler - WinCo Foods, LLC (056098817)
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