Label: BISACODYL tablet, delayed release

  • Category: HUMAN OTC DRUG LABEL

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 July 29, 2013

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  • OTC - ACTIVE INGREDIENT

    Bisacodyl USP 5mg.

  • OTC - PURPOSE

    Stimulant laxative.

  • INDICATIONS AND USAGE

    For temporary relief of occasional constipation and irregularity

    This product generally produces bowel movement in 6 to 12 hours.

  • WARNINGS

    Do not use if you cannot swallow without chewing.

  • OTC - ASK DOCTOR

    If you have

    Stomach pain, nausea or vomiting

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

  • OTC - WHEN USING

    Do not chew or crush tablet(s).

    It may cause stomach discomfort, faintness and cramps.

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

  • OTC - STOP USE

    And ask a doctor if:

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

    You need to use laxative for more than 1 week

  • OTC - PREGNANCY OR BREAST FEEDING

    Ask a health professional before use.

  • OTC - KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE AND ADMINISTRATION

    Take with a glass of water

    Adults and children 12 years and over1 to 3 tablets in a single daily dose
    Children 6 to under 12 years1 tablet in a single daily dose
    Children under 6 yearsAsk a doctor

    OTHER INFORMATION

    Store at 20(-25(C(68(-77(F). Protect from excessive humidity.

  • INACTIVE INGREDIENT

    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, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    8f6065f1-figure-01
  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11534-156
    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)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    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)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code TCL;003
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11534-156-01100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/08/2005
    Labeler - Sunrise Pharmaceutical Inc (168522378)
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