Label: WOMENS LAXATIVE- bisacodyl tablet, delayed release

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 17, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredient

    Bisacodyl USP 5mg

  • Purpose

    Stimulant Laxative

  • Uses

    • for relief of occasional constipation and irregularity
    • this product usually causes bowel movements in 6 to 12 hours
  • Warnings

    Do not use

    • if you cannot swallow without chewing
    • within 1 hour after taking antacid or milk

    Ask a doctor before use if you have

    • abdominal pain
    • nausea
    • vomiting
    • notice a sudden change in bowel habits that persists over a period of 2 weeks

    When using this product

    • do not chew or crush tablets
    • abdominal discomfort, faintness, and cramps may occur

    Stop use and ask a doctor if

    • you need to use more than 1 week
    • rectal bleeding or failure to have a bowel movement after use of a laxative.

    These may be signs of a serious condition.

    Pregnancy/Breastfeeding

    ask a health professional before use.

    Keep out of reach of children

    In case of accidental overdose, get medical help or contact a doctor or Poison Control Center (1-800-222-1222) right away.

  • Directions

    • take with water  

    Adults and children 12 years of age and older: take 1 to 3 tablets in a single dose, once daily  

    Children 6 to 12 years of age: take 1 tablet once daily  

    Children under 6 years of age: consult a doctor

  • Other information

    • store between 68º to 77ºF (20º to 25ºC)
    • do not use if blister unit is broken or torn  
  • Inactive ingredients

    acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow # 6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polyvinyl acetate pthalate, polydextrose, polyethylene glycol, propylparaben, propylene glycol, povidone, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

  • Principal Display Panel

     Women's Laxative

    Women's Laxative

  • INGREDIENTS AND APPEARANCE
    WOMENS LAXATIVE 
    bisacodyl tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-398
    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)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SUCROSE (UNII: C151H8M554)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code 5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-398-851 in 1 CARTON07/01/2014
    125 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00707/01/2014
    Labeler - Marc Glassman, Inc. (094487477)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!