Label: LAXATIVE- 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 May 19, 2021

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

  • Active ingredient

    Active ingredient (in each Suppository)

    Bisacodyl, 10 mg

  • Purpose

    Stimulant Laxative

  • 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.

  • Uses

    • For relief of occasional constipation
    • This product generally produces bowel movement in 15 minutes to 1 hour
  • Do not use

    • more than once per day
    • for a period of longer than one week unless directed by a doctor
    • laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
    • if sealed film around the suppository is torn, damaged, or open
  • Ask a doctor

    • before use if you have noticed a sudden change in bowel habits that persists over a period of two weeks
    • if you are pregnant or nursing a baby
  • Stop use and ask a doctor

    if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

  • Directions

    01b UC_Bisacodyl Suppository_12pk_DF box_Directions

    • Detach one suppository from the strip and remove from foil
    • Carefully insert one suppository well into the rectum
    • Do not use more than once per day
  • Other information

    • Store at room temperature: 15° - 30° C (59° - 86° F) Do not exceed 30° C (86° F)
    • Individually sealed for your protection. Do not use if foil is torn or open.
  • Inactive ingredients

    hydrogenated vegetable oil

  • Warnings

    For rectal use only.


    May cause abdominal discomfort, faintness, rectal burning, and mild cramps.


  • PRINCIPAL DISPLAY PANEL

    01b UC_Bisacodyl Suppository_12pk_PDP

    01b UC_Bisacodyl Suppository_12pk_DF box

  • INGREDIENTS AND APPEARANCE
    LAXATIVE 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-328
    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:63868-328-088 in 1 BOX05/18/2021
    11 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 finalpart33412/21/2007
    Labeler - Chain Drug Marketing Association, Inc. (011920774)
    Registrant - Acino Products, LLC (019385518)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acino Products, LLC019385518manufacture(63868-328)