Label: GENTLE LAXATIVE- bisacodyl tablet, delayed release

  • NDC Code(s): 49348-032-05, 49348-032-10
  • Packager: Strategic Sourcing Services, LLC (Sunmark)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 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 years
    		take 1 tablet in a single daily dose
    children under 6 yearsask a doctor
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • avoid excessive humidity
    • see end flap for expiration date and lot number
  • 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?

    1-800-426-9391

  • Principal display panel

    sunmark®

    COMPARE TO
    DULCOLAX® LAXATIVE TABLETS
    ACTIVE INGREDIENT*

    NDC 49348-032-05

    gentle
    laxative

    BISACODYL USP, 5 mg
    stimulant laxative

    gentle, dependable
    constipation relief

    COMFORT COATED

    ACTUAL
    SIZE

    25 TABLETS

    TAMPER EVIDENT: DO NOT USE IF
    PACKAGE IS OPENED OR IF BLISTER
    UNIT IS TORN, BROKEN OR SHOWS
    ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by
    Sanofi-Aventis Deutschland GMBH, owner of the registered
    trademark Dulcolax® Laxative Tablets. 50844    REV0119B32756

    Distributed by McKesson Corp., via
    Strategic Sourcing Services LLC,
    Memphis, TN 38141
    © 2003 McKesson Corporation
    www.sunmarkbrand.com
    Money Back Guarantee

    Sunmark 44-327

    Sunmark 44-327

  • INGREDIENTS AND APPEARANCE
    GENTLE LAXATIVE 
    bisacodyl tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-032
    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)  
    AMMONIA (UNII: 5138Q19F1X)  
    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)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-032-051 in 1 CARTON03/25/200205/04/2025
    125 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49348-032-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/25/200211/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)03/25/200205/04/2025
    Labeler - Strategic Sourcing Services, LLC (Sunmark) (116956644)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464manufacture(49348-032) , pack(49348-032)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(49348-032) , pack(49348-032)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(49348-032)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(49348-032)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(49348-032)
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