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 21, 2020

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  • 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

  • HOW SUPPLIED

    Product: 50090-5385

    NDC: 50090-5385-0 6 SUPPOSITORY in a BLISTER PACK

  • BISACODYL SUPPOSITORY

    Label Image
  • INGREDIENTS AND APPEARANCE
    BISACODYL 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-5385(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:50090-5385-06 in 1 BLISTER PACK; Type 0: Not a Combination Product11/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/01/2019
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-5385)
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