Label: LAXATIVE ENTERIC COATED- bisacodyl tablet, coated

  • NDC Code(s): 59726-190-03
  • Packager: P & L Development, LLC
  • 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 March 20, 2023

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  • Active ingredient (in each tablet)

     Bisacodyl, USP 5 mg

  • Purpose

     Stimulant laxative

  • Use

    • 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

    Ask a doctor before use if you have

    • stomach pain, nausea or vomiting
    • a sudden change in bowel habits that lasts for more than 2 weeks

    When using this product

    • 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

    Stop use and ask a 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

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

  • Directions

    • take with a glass of water
    adults and children 12 years of age and overtake 1 to 3 tablets in a single daily dose 
    children 6 to under 12 years of agetake 1 tablet in a single dose 
    children under 6 years of ageask a doctor 

  • Other information

    • store between 20-25ºC (68-77oF)
  • 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, and titanium dioxide

  • Questions or Comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • Principal Display Panel

    *Compare to the active ingredient in DULCOLAX®*

    LAXATIVE

    Bisacodyl, 5 mg stimulant laxative

    Gentle, Predictable, Overnight relief

    *This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of Dulcolax®Lasative.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    Distributed by:

    PL Developments

    200 Hicks St Westbury, NY 11590 USA

  • Package Label

    Bisacodyl USP 5mg

    Readyincase Laxative Bisacodyl

  • INGREDIENTS AND APPEARANCE
    LAXATIVE  ENTERIC COATED
    bisacodyl tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59726-190
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) 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)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    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 CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    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:59726-190-031 in 1 CARTON09/01/201012/27/2024
    125 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/01/201012/27/2024
    Labeler - P & L Development, LLC (800014821)
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