Label: BISACODYL suppository

  • NDC Code(s): 57896-443-01, 57896-443-05, 57896-443-12, 57896-443-55, view more
    57896-443-66
  • Packager: GERI-CARE PHARMACEUTICAL CORP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 30, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each suppository)

    Bisacodyl USP, 10 mg

  • PURPOSE

    Purpose

    Stimulant Laxative

  • INDICATIONS & USAGE

    Uses

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

    Warnings

    For rectal use only

    Do not use

    when abdominal pain, nausea, or vomiting are present.

  • ASK DOCTOR

    Ask a doctor before use if you have a sudden change in bowel habits that lasts over a period 2 weeks.

  • WHEN USING

    When using this product you may experience

    • rectal burning
    • mild cramps
    • abdominal discomfort
    • faintness
  • STOP USE

    Stop use and ask a doctor if

    • you have rectal bleeding or you fail to have bowel movement after using a laxative. These may be signs of a serious condition.
    • you need to use a laxative product for more than one week
  • PREGNANCY OR BREAST FEEDING

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • tear off one suppository from the strip
    • peel apart the wrapper
    • continue peeling apart 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 about 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 and over

    1 suppository once daily

    children under 12 yearsAsk a doctor

  • STORAGE AND HANDLING

    Other information

    • store at temperatures below 25 C (77F)
    • Made in India
  • INACTIVE INGREDIENT

    Inactive ingredient hard fat

  • QUESTIONS

    Questions or Comments? 1-800-540-3765

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-443
    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)  
    Product Characteristics
    ColorwhiteScore    
    ShapeBULLETSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-443-122 in 1 CARTON11/01/2019
    1NDC:57896-443-666 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:57896-443-0510 in 1 CARTON11/01/2019
    2NDC:57896-443-555 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:57896-443-0120 in 1 CARTON11/01/2019
    3NDC:57896-443-555 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00711/01/2019
    Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254)
    Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)