Label: GENTLE LAXATIVE BISACODYL suppository

  • NDC Code(s): 13709-321-01
  • Packager: NeilMed Pharmaceuticals Inc
  • 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 August 24, 2023

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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 not finalpart33408/24/2023
    Labeler - NeilMed Pharmaceuticals Inc (799295915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeilMed Pharmaceuticals Inc.799295915manufacture(13709-321)
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