Label: GENTLE LAXATIVE ENTERIC COATED- bisacodyl tablet, coated 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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

  • Active ingredient (in each tablet)

    Bisacodyl, USP 5 mg

    Close
  • Purpose

    Stimulant laxative

    Close
  • Use

    • for temporary relief of occasional constipation and irregularity
    • this product generally produces a bowel movement in 6 to 12 hours
    Close
  • 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
    • it may cause stomach discomfort, faintness and cramps

    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

    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.

    Close
  • Directions

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

    • store between 20º-25ºC (68º-77ºF)
    Close
  • 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, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

    Close
  • Questions or comments?

     Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

    Close
  • Principal Display Panel

    COMPARE TO DULCOLAX® ACTIVE INGREDIENT*

    Gentle Laxative

    For relief of occasional constipation

    BISACODYL

    ENTERIC COATED

    TABLETS 5 mg EACH

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

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    *This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of Dulcolax® Laxative.

    Distributed By McKesson

    One Post Street, San Francisco, CA  94104

    Please visit us at www.sunmarkbrand.com

    Close
  • Package Label

    Bisacodyl 5 mg

    Sunmark Gentle Laxative Tablet

    Close
  • INGREDIENTS AND APPEARANCE
    GENTLE LAXATIVE  ENTERIC COATED
    bisacodyl tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:49348-599
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BISACODYL (BISACODYL) BISACODYL 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    ACACIA  
    CALCIUM SULFATE ANHYDROUS  
    ANHYDROUS LACTOSE  
    CARNAUBA WAX  
    SILICON DIOXIDE  
    STARCH, CORN  
    D&C YELLOW NO. 10  
    FD&C YELLOW NO. 6  
    GELATIN  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    SHELLAC  
    SODIUM STARCH GLYCOLATE TYPE A POTATO  
    STEARIC ACID  
    TALC  
    TITANIUM DIOXIDE  
    Polyvinyl Acetate Phthalate  
    SUCROSE  
    POVIDONES  
    FERRIC OXIDE RED  
    FERRIC OXIDE YELLOW  
    FERROSOFERRIC OXIDE  
    POLYETHYLENE GLYCOLS  
    ALUMINUM OXIDE  
    Product Characteristics
    Color ORANGE Score no score
    Shape ROUND Size 6mm
    Flavor Imprint Code TCL003
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-599-05 1 in 1 CARTON
    1 25 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 01/10/2013
    Labeler - McKesson (Sunmark) (177667227)
    Close