RUGBY CAL-GEST ANTACID ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [RUGBY LABORATORIES, INC.]

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RUGBY CAL-GEST ANTACID ASSORTED FLAVORS (ANTACID TABLETS) TABLET, CHEWABLE [RUGBY LABORATORIES, INC.]
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NDC 0536-1007-15
Set ID a43184c4-d225-4539-b651-4d96535f208f
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART331
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  • Active ingredient (per tablet)

    Calcium Carbonate USP 500mg

  • 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 taking a prescription drug. Antacids may interact with certain prescription drugs.

    When using this product

    •
    do not take more than 15 tablets in 24 hours
    •
    if pregnant do not take more than 10 tablets in 24 hours.
    •
    do not use the maximum dosage for more than 2 weeks except under 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 200 mg
    •
    Store at room temperature. Keep the container tightly closed
  • Inactive ingredients

    adipic acid, D&C red#27 lake, 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

  • Package/Label Principal Display Panel

    COMPARE TO active ingredient in TUMS®*

    NDC# 0536-1007-15

    Rugby®

    CALCIUM

    Cal-Gest®

    Antacid Tablets

    Regular Strength

    Calcium Carbonate 500 mg

    Assorted Fruit

    Naturally & Artificially Flavored

    150 CHEWABLE TABLETS

    Safety sealed: Do not use if printed seal under cap is torn or missing

    GLUTEN-FREE

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

    Distributed by Rugby Laboratories

    17177 N Laurel Park Drive, Suite 233

    Livonia, MI 48152, USA

    www.rugbylaboratories.com

    Rugby Cal-Gest Antacid Tablets 150 Chewable Tablets
  • INGREDIENTS AND APPEARANCE
    RUGBY CAL-GEST ANTACID  ASSORTED FLAVORS
    antacid tablets tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE500 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
    ColorWHITEScoreno score
    ShapeROUNDSize16mm
    FlavorFRUITImprint Code RP101
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1007-15150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33110/30/2019
    Labeler - Rugby Laboratories, Inc. (079246066)
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