EXTRA STRENGTH SUGAR FREE ORANGE CREAM FLAVOR (CALCIUM CARBONATE) TABLET, CHEWABLE [RARITAN PHARMACEUTICALS INC]

EXTRA STRENGTH SUGAR FREE ORANGE CREAM FLAVOR (CALCIUM CARBONATE) TABLET, CHEWABLE [RARITAN PHARMACEUTICALS INC]
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NDC 68163-202-90
Set ID 50d9e7a4-79b8-4315-8717-0f416541fc01
Category HUMAN OTC DRUG LABEL
Packager Raritan Pharmaceuticals Inc
Generic Name
Product Class
Product Number
Application Number PART331
  • 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 9 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 as symptoms occur ,or as directed by a doctor
    do not take for symptoms that persist for more than 2 weeks unless advised by a doctor
  • Other Information

    each tablet contains: elemental calcium 300 mg
    store below 30°C (86°F).
  • Inactive ingredients

    adipic acid, flavors, magnesium stearate, maltodextrin, sorbitol, starch, sucralose, FD&C Yellow No. 6 lake.

    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

    NDC 68163-202-90

    DRxCHOICE®

    Compare to Tums® active ingredient*

    EXTRA STRENGTH

    Antacid

    Tablets

    Calcium Carbonate USP 750 mg

    Sugar-Free

     
    Relieves:
    Acid Indigestion
    Sour Stomach
    Heartburn
     
    Orange Cream Flavor
     
    Naturally and Artificially Flavored
     
    GLUTEN FREE

    90 CHEWABLE TABLETS

    K PARVE

    Distributed 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, TUMS®.

    DRx Choice Extra Strength Antacid 90 CT Orange Cream Flavor
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH SUGAR FREE  ORANGE CREAM FLAVOR
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-202
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SORBITOL (UNII: 506T60A25R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize16mm
    FlavorORANGE (Cream) Imprint Code RP102SF
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68163-202-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/18/2019
    Labeler - Raritan Pharmaceuticals Inc (127602287)

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