Label: BISACODYL STIMULANT LAXATIVE- bisacodyl tablet, delayed release

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 21, 2012

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  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)
    Bisacodyl 5 mg
  • PURPOSE

    Purpose
    Laxative
  • INDICATIONS & USAGE

    Uses
    • relieves occasional constipation
    • generally produces bowel movement in 6-12 hours
  • WARNINGS

    Warnings
  • DO NOT USE

    Do not use
    • for longer than one week
    • when abdominal pain, nausea or vomiting are present
    • in children under 6 years of age
    • in persons who cannot swallow without chewing
  • ASK DOCTOR

    Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.
  • WHEN USING

    When using this product
    • do not take dose within one hour of taking an antacid or milk
    • you may experience abdominal discomfort, faintness and cramps
  • STOP USE

    Stop use and ask a doctor if
    • you have rectal bleeding
    • you fail to have a bowel movement after use of this product
    These may indicate a serious condition.
  • PREGNANCY OR BREAST FEEDING

    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
    DO NOT CHEW TABLETS
    adults and children 12 years and over: 1-3 tablets once daily
    children 6 to 11 years: 1 tablet once daily
    children under 6 years: ask a doctor

  • STORAGE AND HANDLING

    Other information
    store at 20°-25°C (68°-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D-C yellow #10 aluminum lake, FD-C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide
  • QUESTIONS

    Questions or comments?
    call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday
  • PRINCIPAL DISPLAY PANEL


    BOTTLE LABEL


    Bisacodyl

    Delayed-Release Tablets USP, 5 mg

    Enteric Coated Stimulate Laxative

    NDC 54868-2497-0

    100 tablets



    Distributed by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma      74146


  • INGREDIENTS AND APPEARANCE
    BISACODYL  STIMULANT LAXATIVE
    bisacodyl tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2497(NDC:0536-3381)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    POVIDONE (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code TCL;003
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-2497-0100 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/22/2011
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel(54868-2497)
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