Label: BISACODYL tablet, delayed release

  • NDC Code(s): 71335-2010-0, 71335-2010-1, 71335-2010-2, 71335-2010-3, view more
    71335-2010-4, 71335-2010-5, 71335-2010-6, 71335-2010-7, 71335-2010-8, 71335-2010-9
  • Packager: Bryant Ranch Prepack
  • This is a repackaged label.
  • Source NDC Code(s): 0904-6748
  • 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 March 24, 2023

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  • Active ingredient (in each tablet)

    Bisacodyl USP, 5 mg

  • Purpose

    Stimulant laxative

  • Uses

    • for 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)
    • do not use within 1 hour after taking an antacid or milk
    • you may have stomach discomfort, faintness and cramps

    Stop use and ask a doctor if

    • you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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 and overtake 1 to 3 tablets in a single daily dose
    children 6 to under 12 yearstake 1 tablet in a single daily dose
    children under 6 yearsask a doctor

  • Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • avoid excessive humidity
    • use by expiration date on package
  • Inactive ingredients

    acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

  • Questions or comments?

    (800)-616-2471

  • HOW SUPPLIED

    NDC: 71335-2010-0: 25 Tablets in a BOTTLE

    NDC: 71335-2010-1: 30 Tablets in a BOTTLE

    NDC: 71335-2010-2: 2 Tablets in a BOTTLE

    NDC: 71335-2010-3: 3 Tablets in a BOTTLE

    NDC: 71335-2010-4: 4 Tablets in a BOTTLE

    NDC: 71335-2010-5: 10 Tablets in a BOTTLE

    NDC: 71335-2010-6: 90 Tablets in a BOTTLE

    NDC: 71335-2010-7: 8 Tablets in a BOTTLE

    NDC: 71335-2010-8: 100 Tablets in a BOTTLE

    NDC: 71335-2010-9: 20 Tablets in a BOTTLE

  • PRINCIPAL DISPLAY PANEL

    Bisacodyl 5mg Tablet

    Label
  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-2010(NDC:0904-6748)
    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 CARBONATE (UNII: H0G9379FGK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    AMMONIA (UNII: 5138Q19F1X)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-2010-025 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    2NDC:71335-2010-130 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    3NDC:71335-2010-22 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    4NDC:71335-2010-33 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    5NDC:71335-2010-44 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    6NDC:71335-2010-510 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    7NDC:71335-2010-690 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    8NDC:71335-2010-78 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    9NDC:71335-2010-8100 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    10NDC:71335-2010-920 in 1 BOTTLE; Type 0: Not a Combination Product02/24/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/01/2018
    Labeler - Bryant Ranch Prepack (171714327)
    Registrant - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-2010) , RELABEL(71335-2010)
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