Label: LAXATIVE- bisacodyl suppository

  • 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 December 21, 2021

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  • Active Ingredient (in each suppository)

    Bisacodyl, 10  mg

  • Purpose

    Stimulant Laxative

  • Uses

    • For relief of occasional constipation
    • This product generally produces bowel movement in 15 minutes to 1 hour
  • Warnings

    For rectal use only. ​May cause abdominal discomfort, faintness, rectal burning, and mild cramps.

    Do not use

    • more than once per day
    • for a period longer than one week unless directed by a doctor
    • laxative products when abdominal pain, nausea, or vomitting 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 persist 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.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Table

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

    store below 30° C (86° F)

  • Inactive ingredient

    hydrogenated vegetable oil

  • PRINCIPAL DISPLAY PANEL

    Label 1

    Label 2

    Label 3

  • INGREDIENTS AND APPEARANCE
    LAXATIVE 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70795-1010
    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:70795-1010-88 in 1 BOX03/29/2017
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70795-1010-550 in 1 BOX04/22/2017
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:70795-1010-1100 in 1 PACKAGE04/22/2017
    31 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 finalpart33403/29/2017
    Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)
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