CALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [RUGBY LABORATORIES]

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CALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH (CALCIUM CARBONATE) TABLET, CHEWABLE [RUGBY LABORATORIES]
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NDC 0536-1049-22
Set ID d761954f-940e-4833-87b7-173a921aade1
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories
Generic Name
Product Class
Product Number
Application Number PART331
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  • Active ingredient (per tablet)

    Calcium Carbonate USP 750mg

  • Purpose

    Antacid

  • Uses

    relieves

    •
    heartburn
    •
    sour stomach
    •
    acid indigestion
    •
    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 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 at room temperature. Keep the container tightly closed.
  • Inactive ingredients

    adipic acid, D&C red #27lake, D&C yellow#10 lake, dextrose, FD&C blue #1 lake, FD&C yellow#6 lake, flavors, magnesium stearate, maltodextrin, starch, sucralose

  • Questions or comments ?

    1-800-645-2158

  • Principal Display Panel

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

    COMPARE TO the active ingredient of TUMS® EXTRA STRENGTH

    NDC 0536-1049-22

    Rugby®

    CALCIUM

    Antacid

    Tablets

    Extra Strength

    Calcium Carbonate 750 mg

    ASSORTED FRUIT

    Naturally &Artificially Flavored

    96 Chewable TABLETS

    GLUTEN-FREE

    *This product is not manufactured or distributed by GlaxoSmithKline LLC,

    Owner of the registered trademark,

    Extra Strength Tums®

    Distributed by Rugby laboratories

    17177 n Laurel Park Drive, Suite 233

    Livonia, MI, 48152, USA

    www.rugbylaboratories.com

    Calcium Antacid Tablets Extra Strength
  • INGREDIENTS AND APPEARANCE
    CALCIUM ANTACIDEXTRA STRENGTH  EXTRA STRENGTH
    calcium carbonate tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1049
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D) CALCIUM CARBONATE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorYELLOW, GREEN, RED, ORANGEScoreno score
    ShapeROUNDSize17mm
    FlavorFRUIT (lemon, orange, cherry, lime) Imprint Code RP102
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1049-2296 in 1 BOTTLE; Type 0: Not a Combination Product03/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33103/15/2015
    Labeler - Rugby Laboratories (079246066)
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