EZ2GO (BISACODYL) PILL [VALLEY MEDICAL PRODUCTS,LLC]

EZ2GO (BISACODYL) PILL [VALLEY MEDICAL PRODUCTS,LLC]
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NDC 76470-011-11
Set ID fc310583-bfeb-42c6-a048-80b79b44f015
Category HUMAN OTC DRUG LABEL
Packager Valley Medical Products,LLC
Generic Name
Product Class
Product Number
Application Number PART334
  • ACTIVE INGREDIENT

    Active Ingredients

    (In each tablet)

    Bisacodyl USP 5 mg


  • PURPOSE

    Purpose

    Stimulant Laxative


  • WARNINGS

    Warnings

    Do not use if you cannot swallow without chewing

  • ASK DOCTOR

    Ask a doctor before use if you have

    Stomach pain, nausea or bleeding

    A sudden change in bowel habits that lasts more than 2 weeks

  • INDICATIONS & USAGE

    Uses

    -For temporary relief of occasional

    constipation and irregularity

    Generally produces a bowel movement

    in 6 to 12 hours

    When using this product

    Do not chew or cush tablet(s)

    Do not use within 1 hour after taking an antacid  or milk

    It may cause stomach discomfort, faintness and cramps

  • STOP USE

    Stop use and ask doctor if

    You have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition

    You need to use a laxative for more than 1 week

    If pregnant or breast-feeding, ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.


  • DOSAGE & ADMINISTRATION

    Directions

    Take with a glass of water

    Adults and children 12 years of age and over: 1 to 3 tablets in a single daily dose.

    Children 6 to 12 years of age: 1 tablet in a single daily use.




  • OTHER SAFETY INFORMATION

    Other information:

    Store at 20-25 C (68-77 F)

    Protect from excessive humidity

    Packaged for your protection.

    Do not use if individual seals are broken.


  • INACTIVE INGREDIENT

    Inactive Ingredients

    Calcium Carbonate, Dicalcium Phospate,

    Cellulose, Stearic Acid, Maltodextrin,

    Croscarmellose Sodium, Pharmaceutical

    Glaze, Magnesium Stearate, Silicon

    Dioxide, Carnauba Wax

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    EZ2GO  
    bisacodyl pill
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76470-011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg  in 5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SHELLAC (UNII: 46N107B71O)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code TCLover003
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76470-011-1120 mg in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2015
    Labeler - Valley Medical Products,LLC (969389407)

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