Label: LEADER GENTLE LAXATIVE- bisacodyl suppository suppository

  • NDC Code(s): 0904-6981-12, 0904-6981-13
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 14, 2024

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

  • Active Ingredient (in each Suppository)

                                                                       Purpose

    Bisacodyl USP, 10 mg.................................Stimulant Laxative

  • Uses

    Uses - For temporary relief of occasional constipation and irregularity

    -This product generally produces bowel movement in 15 minutes to 1 hour

  • Warnings

    For rectal use only.

  • Do not use

    Do not use - more than once per day  - laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor- for a period of longer than one week unless directed by a doctor 

  • Ask a doctor

    Ask a doctor before use if you have - noticed a sudden change in bowel habits that persists over a period of two weeks

  • When using this product

    When using this product - May cause abdominal discomfort, faintness, rectal burning, and mild cramps

  • Stop use and ask a doctor

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

  • If pregnant 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. (1-800-222-1222) right away.

  • Directions

    Adults and children 12 years of age and older              Children 6 to under 12 years                 Children under 6

    One suppository once daily                                         1/2 suppository once daily                    Ask doctor.

    -Detach one suppository from the strip and remove from foil - Carefully insert one suppositry well into the rectum, pointed end first

    - Retain about 15 to 20 minutes

  • Other information

    Other information - Storage temperature: not to exceed 30 oC (86 oF)

    - Lot No. & Exp. Date: see wrapper or box

  • Inactive ingredient

    Inactive ingredient  Hydrogenated vegetable oil

  • Purpose

    Stimulant Laxative

  • Qutestions?

    Questions? 1-724-733-7381

  • Product Label

    Product Label

  • INGREDIENTS AND APPEARANCE
    LEADER GENTLE LAXATIVE 
    bisacodyl suppository suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6981
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg  in 2000 mg
    Inactive Ingredients
    Ingredient NameStrength
    PALM KERNEL OIL (UNII: B0S90M0233)  
    Product Characteristics
    ColorwhiteScore    
    ShapeBULLETSize32mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6981-121 in 1 CARTON10/01/2019
    1NDC:0904-6981-13120 mg in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00710/01/201901/01/2025
    Labeler - Major Pharmaceuticals (191427277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack LLC009248480manufacture(0904-6981)