Label: CALCIUM ANTACIDEXTRA STRENGTH EXTRA STRENGTH- calcium carbonate 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 December 10, 2020

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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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