EXTRA STRENGTH ANTACID ASSORTED BERRIES (CALCIUM CARBONATE) TABLET, CHEWABLE [RARITAN PHARMACEUTICALS INC]

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EXTRA STRENGTH ANTACID ASSORTED BERRIES (CALCIUM CARBONATE) TABLET, CHEWABLE [RARITAN PHARMACEUTICALS INC]
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NDC 68163-102-24
Set ID 07a50168-6b05-4c99-9969-7d7f0aa54f30
Category HUMAN OTC DRUG LABEL
Packager RARITAN PHARMACEUTICALS INC
Generic Name
Product Class
Product Number
Application Number PART331
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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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