Label: BISACODYL suppository

  • 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 December 15, 2020

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  • Active Ingredients (in each suppository)

    Bisacodyl USP, 10 mg

  • Purpose

    Stimulant Laxative

  • Uses

    • relieves occasional constipation
    • this product generally produces a bowel movement in 15 minutes to 1 hour
  • Warnings

    For rectal use only.

  • Do not use

    • when abdominal pain, nausea or vomiting are present
  • Ask a doctor before use if you have

    a sudden change in bowel habits that lasts over a period of 2 weeks

  • When using this product

    you may experience

    • rectal burning
    • mild cramps
    • abdominal discomfort
    • faintness
  • Stop use and ask a doctor if

    • rectal bleeding occurs
    • you fail to have a bowel movement after using a laxative. These may be signs of a serious condition.
    • you need to use a laxative for more than one week
  • If pregnant or breast-feeding

    ask a health professional before use.

  • Keep out of reach of children

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • tear off one suppository from the strip
    • tear and peel the wrapper in a downward motion
    • continue tearing downward to almost the full length of the suppository (see illustration at the right)
    • gently remove the suppository from the wrapper
    • lie on your side and push suppository, with pointed end first, high into the rectum so it will not slip out
    • retain it for 15 to 20 minutes
    • do not exceed recommended dose
    • if suppository seems soft, place in refrigerator for a short time before use

    adults and children 12 years of age and over

    		1 suppository once daily
    children under 12 yearsAsk a doctor
  • Other information

    store at temperatures below 30° C (86° F)

  • Inactive ingredient

    hydrogenated vegetable oil

  • BISACODYL Laxative Suppository Label

    bis

  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-444(NDC:68784-102)
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    FAT, HARD (UNII: 8334LX7S21)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-444-122 in 1 CARTON06/01/2005
    16 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:57896-444-014 in 1 CARTON06/01/2005
    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 not finalpart33401/01/200501/01/2023
    Labeler - Geri-Care Pharmaceutical Corp (611196254)
    Registrant - Geri-Care Pharmaceutical Corp (611196254)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geri-Care Pharmaceutical Corp611196254repack(57896-444)
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