Label: EXTRA STRENGTH ANTACID ASSORTED BERRIES- calcium carbonate tablet, chewable

  • NDC Code(s): 68163-102-24, 68163-102-44
  • Packager: RARITAN PHARMACEUTICALS INC
  • 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 September 1, 2023

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  • Active ingredient (per tablet)

    Calcium Carbonate USP 750 mg

  • Purpose

    Antacid

  • Uses

    relieves

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

    Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    •
    do not take more than 10 tablets in 24 hours
    •
    If pregnant do not take more than 6 tablets in 24 hours
    •
    do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
  • Keep out of reach of children.

  • Directions

    •
    adults and children 12 years of age and over: chew 2-4 tablets completely as symptoms occur or as directed by a doctor. Do not swallow tablets whole.
    •
    do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
  • Other Information

    •
    each tablet contains: elemental calcium 300mg
    •
    store at room temperature. Keep the container tightly closed.
  • Inactive ingredients

    adipic acid, dextrose, FD&C Blue No. 1, FD&C Red No. 40, flavors, magnesium stearate, maltodextrin, starch, sucralose.

    Questions or comments?

    1-866-467-2748

    SAFETY SEALED: DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

  • Package/Label Principal Display Panel

    *Compare to the active ingredient in Extra Strength Tums®

    EXTRA STRENGTH

    Antacid Tablets

    Calcium Carbonate Tablets 750 mg

    Fast Relief of Upset Stomach, Heartburn and Acid Indigestion

    Assorted Berries

    Naturally & Artificially Flavored

    K PARVE

    GLUTEN-FREE

    Manufactured By:

    Raritan Pharmaceuticals

    8 Joanna Court

    East Brunswick, NJ 08816

    *This product is not manufactured or distributed by GlaxoSmithKline LLC, owner of the registered trademark, Extra Strength Tums®.

    Package Label 96 Chewable Tablets

    DRx Choice Extra Strength Assorted Berry 96 CT

    Package Label 44 Chewable Tablets

    DRx Choice Extra Strength Assorted Berry 44 CT
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH ANTACID  ASSORTED BERRIES
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-102
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorPINK, BLUE, PURPLE (LIGHT) Scoreno score
    ShapeROUNDSize16mm
    FlavorBERRY (ASSORTED) Imprint Code RP102
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-102-2496 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2019
    2NDC:68163-102-4444 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/01/2019
    Labeler - RARITAN PHARMACEUTICALS INC (127602287)
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