Label: AVEDANA GENTLE LAXATIVE- bisacodyl suppository

  • NDC Code(s): 43749-460-16, 43749-460-17
  • Packager: Unipack, Inc.
  • 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 November 20, 2021

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  • 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 not finalpart33409/17/2017
    Labeler - Unipack, Inc. (009248480)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(43749-460) , label(43749-460)