Label: BISACODYL tablet

  • NDC Code(s): 68210-4106-1, 68210-4106-2
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient (in each tablet)

    Bisacodyl (USP) 5 mg

  • Purpose

    Stimulant laxative

  • Uses

    • 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 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

  • PREGNANCY OR BREAST FEEDING

    Ifpregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

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

  • OTHER SAFETY INFORMATION

    Other information
    each tablet contains: magnesium 5 mg
    ■ store at 20-25°C (68-77°F)
    ■ protect from excessive humidity

  • 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? 1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    CABINET

    Bisacodyl Tablets,
    USP 5 mg

    image description

    image description

  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4106
    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)  
    GELATIN (UNII: 2G86QN327L)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    POVIDONE K30 (UNII: U725QWY32X)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code TCL003
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4106-21 in 1 CARTON07/06/2020
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68210-4106-175 in 1 PACKAGE; Type 0: Not a Combination Product07/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00707/06/2020
    Labeler - Spirit Pharmaceuticals LLC (179621011)