Label: BISACODYL tablet, delayed release

  • Category: HUMAN OTC DRUG LABEL

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 August 9, 2011

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  • ACTIVE INGREDIENT

    Bisacodyl USP 5mg.

  • PURPOSE

    Stimulant laxative.

  • INDICATIONS AND USAGE

    For temporary 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 DOCTOR BEFORE USE IF YOU HAVE

    Stomach pain, nausea or vomiting

    A sudden change in bowel habits that lasts for more than 2 weeks.

  • WHEN USING THIS PRODUCT

    Do not chew or crush tablet(s).

    It may cause stomach discomfort, faintness and cramps.

    Do not use within 1 hour after taking an antacid or milk.

  • STOP USE AND ASK A DOCTOR IF

    You have rectal bleeding or no bowel movement after using this product. These could be signs of serious condition.

    You need to use laxative for more than 1 week

  • IF PREGNANT OR BREAST FEEDING

    Ask a health professional before use.

  • DOSAGE AND ADMINISTRATION

    Dosage and Administration text

  • 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 over1 to 3 tablets in a single daily dose
    Children 6 to under 12 years1 tablet in a single daily dose
    Children under 6 yearsAsk a doctor
  • OTHER INFORMATION

    Store at 20°-25°C(68°-77°F)

  • INACTIVE INGREDIENT

    Calcium sulfate, carnuba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow # 10, edible ink, FD & C yellow #6, gelatin, hydroxypropylymethyl cellulose, kaolin, lactose, magnesium stearate, methacrylic acid copolymer, microcrystalline celloluse, mineral oil, polyethylene glycol, propylene glycol, stearic acid, sucrose, sugar, talc, titanium dioxide, triethyl citrate.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    6be65bdd-figure-01
  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl tablet, delayed release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11534-013
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM SULFATE (UNII: WAT0DDB505)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    KAOLIN (UNII: 24H4NWX5CO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code S1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11534-013-2525 in 1 BOTTLE
    2NDC:11534-013-01100 in 1 BOTTLE
    3NDC:11534-013-031000 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33407/08/2005
    Labeler - Sunrise Pharmaceutical Inc (168522378)
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