Label: LAXATIVE- bisacodyl tablet, sugar coated

  • NDC Code(s): 11822-0327-5, 11822-0327-6, 11822-0327-7
  • Packager: Rite Aid Corporation
  • 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 May 7, 2021

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

  • 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 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

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25ºC (77ºF); 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

    NDC 11822-0327-5

    Compare to the active ingredient in
    Dulcolax® Laxative Tablets*

    LAXATIVE
    BISACODYL USP 5 mg

    STIMULANT LAXATIVE

    Gentle, dependable constipation relief
    Enteric coated

    ACTUAL SIZE

    50
    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        REV0119F32715

    DISTRIBUTED BY:
    RITE AID, 30 HUNTER LANE,
    CAMP HILL, PA 17011
    www.riteaid.com

    SATISFACTION
    GUARANTEE
    If you’re not satisfied, we’ll
    happily refund your money.

    Rite Aid 44-327

    Rite Aid 44-327

  • INGREDIENTS AND APPEARANCE
    LAXATIVE 
    bisacodyl tablet, sugar coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0327
    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)  
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SHELLAC (UNII: 46N107B71O)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    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)  
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColororangeScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0327-61 in 1 CARTON03/25/2002
    125 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:11822-0327-52 in 1 CARTON03/25/2002
    225 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:11822-0327-71 in 1 CARTON03/25/2002
    3200 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/25/2002
    Labeler - Rite Aid Corporation (014578892)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894manufacture(11822-0327)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464pack(11822-0327)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837pack(11822-0327)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305pack(11822-0327)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088pack(11822-0327)