Label: AVEDANA GENTLE LAXATIVE- bisacodyl suppository

  • NDC Code(s): 43749-460-16, 43749-460-17
  • Packager: Unipack LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 4, 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 temporarily 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 - 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

  • 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.

  • 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 suppository well into the rectum

    -Do not use more than once per day

  • Other information

    Other information - Store at room temperature: 15 o - 30 oC (59 o - 86 oF). Do not exceed 30 oC (86 oF) - Individually sealed for your protection.  Do not use if foil is torn or open

  • Inactive ingredient

    Inactive ingredient  Hydrogenated vegetable oil

  • Purpose

    Stimulant Laxative

  • Label

    Avedana ® Bisacodyl Suppositories

    Product Label

  • INGREDIENTS AND APPEARANCE
    AVEDANA GENTLE LAXATIVE 
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-460
    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)  
    Product Characteristics
    ColorwhiteScore    
    ShapeBULLETSize32mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43749-460-164 in 1 CARTON09/17/2017
    1NDC:43749-460-174 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00709/17/2017
    Labeler - Unipack LLC (009248480)
    Registrant - Unipack LLC (116015769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack LLC009248480manufacture(43749-460)