Label: BISACODYL tablet, delayed release

  • NDC Code(s): 68016-688-10, 68016-688-25
  • Packager: Chain Drug Consortium
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 16, 2024

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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

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

    When using this product

    • do not use within 1 hour after taking an antacid or milk
    • do not chew or crush tablet(s)
    • you may have stomach discomfort, faintness and cramps

    Stop use and ask a doctor if

    • you need to use a laxative for more than 1 week
    • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

    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 (1-800-222-1222) right away.

  • Directions

    • take with a glass of water
    adults and children
    12 years and over    		take 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

    • 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

    Premier
    Value®

    *COMPARE TO THE ACTIVE INGREDIENT IN DULCOLAX® LAXATIVE TABLETS

    Bisacodyl, 5 mg
    Bisacodyl USP, 5 mg

    STIMULANT LAXATIVE

    Gentle, dependable
    constipation relief

    Comfort coated

    100 Tablets

    actual size

    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED

    *This product is not manufactured or distributed by Sanofi-Aventis Deutschland GMBH, owner of the registered trademark Dulcolax® Laxative Tablets.
    50844       REV0119A32712

    Distributed By:
    Pharmacy Value Alliance, LLC
    407 East Lancaster Avenue,
    Wayne, PA 19087

    If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

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

    Premier Value 44-327

    Premier Value 44-327

  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-688
    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 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)  
    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:68016-688-101 in 1 CARTON03/25/2002
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:68016-688-251 in 1 CARTON03/25/2002
    225 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)03/25/2002
    Labeler - Chain Drug Consortium (101668460)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464manufacture(68016-688) , pack(68016-688)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837manufacture(68016-688) , pack(68016-688)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(68016-688)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(68016-688)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.117025878manufacture(68016-688)
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