Label: GENTLE LAXATIVE BISACODYL suppository

  • NDC Code(s): 13709-321-01
  • Packager: NeilMed Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2025

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  • Drug Facts : Active ingredient

    (in each suppository)
    Bisacodyl 10 mg

  • Drug facts

    Purpose
    Bisacodyl 10 mg ................................. Stimulant Laxative

  • Uses

    ■ for relief of occasional constipation
    ■ this product generally produces bowel movement in 15 to 60 minutes

  • Warnings


    ■ For rectal use only

  • Do not use


    ■ when abdominal pain, nausea or vomiting are present
    ■ for a period longer than 1 week

  • Ask a doctor before use

    if you have noticed a sudden change in bowel habits that lasts over a period of 2 weeks

  • When using this product

    it may cause abdominal discomfort, faintness, rectal bleeding and mild cramps

  • Stop use and ask a doctor if

    ■ you have rectal bleeding
    ■ you fail to have a bowel movement after using this product. This may indicate a serious condition

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    ■ detach one suppository from the strip
    ■ remove wrapper before inserting into the rectum


    adults and children 12 and over : 1 suppository once daily
    children 6 to under 12 years : ½ suppository once daily
    children under 6 years : do not use

  • Other information

    ■ Store at room temperature. Do not exceed 30° C (86° F)
    ■ Lot No. & Exp. Date: see wrapper or box

  • Inactive ingredient

    hydrogenated vegetable oil

  • Questions?

    Adverse Drug Event Call: 1(877) 477-8633

  • Tamper evident seal:

    Do not use if wrapper on an individual suppository is broken or missing.

  • INTENDED USE OF THE DEVICE

    Prompt, predictable relief from constipation

  • Package Label

    Gentle Laxative Bisacodyl

  • INGREDIENTS AND APPEARANCE
    GENTLE LAXATIVE BISACODYL 
    gentle laxative bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-321
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    PALM KERNEL OIL (UNII: B0S90M0233)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13709-321-015 in 1 CARTON08/24/2023
    16 in 1 BLISTER PACK
    11 in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01508/24/2023
    Labeler - NeilMed Pharmaceuticals Inc (799295915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeilMed Pharmaceuticals Inc.799295915manufacture(13709-321)
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