CALCIUM CARBONATE 10 GR (648 MG) (ANTACID) (CALCIUM CARBONATE 10GR (648 MG)) TABLET [RUGBY LABORATORIES]

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  • CALCIUM CARBONATE 10 GR (648 MG) (ANTACID) (CALCIUM CARBONATE 10GR (648 MG)) TABLET [RUGBY LABORATORIES]

CALCIUM CARBONATE 10 GR (648 MG) (ANTACID) (CALCIUM CARBONATE 10GR (648 MG)) TABLET [RUGBY LABORATORIES]
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NDC 0536-1206-10
Set ID f21c8cf7-45cb-492b-bf4a-462024a54569
Category HUMAN OTC DRUG LABEL
Packager RUGBY LABORATORIES
Generic Name
Product Class
Product Number
Application Number PART331
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  • Active ingredient (in each tablet)

    Calcium Carbonate 10 gr (648 mg)

  • Purpose

    Antacid

  • Uses

    relieves

    • acid indigestion
    • heartburn
    • sour stomach
    • upset stomach associated with these symptoms
  • Warnings


    Ask a doctor before use if you have

    • kidney stones
    • a calcium-restricted diet

    Ask a doctor or pharmacist before use if you are

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

    Stop use and ask a doctor if

    symptoms last more than 2 weeks.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.


  • Directions

    • take one to four tablets daily
    • do not take more than 4 tablets in 24 hours
    • do not use the maximum dosage for more than two weeks
  • Other information

    • each tablet contains: calcium 260 mg
    • store at room temperature
  • Inactive ingredients

    acacia, croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

  • Questions or comments?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING

    This is a bulk package. Dispense contents with a child-resistant closure in a tight, light-resistant container as defined in the USP.

  • PRINCIPAL DISPLAY PANEL

    NDC 0536-1206-10

    Rugby ®

    Calcium

    Carbonate

    10 gr (648 mg)

    ANTACID

    1000 TABLETS

    Rugby Calcium Carbonate 10 gr Product Label

  • INGREDIENTS AND APPEARANCE
    CALCIUM CARBONATE 10 GR (648 MG)  (ANTACID)
    calcium carbonate 10gr (648 mg) tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1206
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CARBONATE ION - UNII:7UJQ5OPE7D, CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE648 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code PH046
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1206-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33102/28/2019
    Labeler - RUGBY LABORATORIES (079246066)
    Registrant - Pharbest Pharmaceuticals Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals Inc.557054835manufacture(0536-1206) , pack(0536-1206) , label(0536-1206)
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