Label: WALGREENS GENTLE LAXATIVE- bisacodyl suppository suppository

  • NDC Code(s): 0363-0466-30, 0363-0466-31
  • Packager: Walgreens
  • 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 3, 2020

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  • Active Ingredient (in each Suppository)

    Active Ingredient                                              Purpose

    (in each Suppository)

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

  • Uses

    -for relief of occasional constipation

    -this product generally produces bowel movement in 1/4 to 1 hour

  • Warnings

    For rectal use only.

  • Do not use

    Do not use

    -when abdominal pain, nausea, or vomiting are present

    -for a period of longer than 1 week

  • Ask a doctor

    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

    When using this product it may cause abdominal discomfort, faintness, rectal burning and mild cramps

  • Stop use and ask a doctor if

    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

    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

    -detach one suppository from the strip

    -remove wrapper before inserting into the rectum

    adults and children 12 years of age and older         1 suppository once daily            

    children 6 to under 12 years                                     1/2 suppository once daily

    children under 6 years                                              do not use

  • Other information

    Other information

    -Store at room temperature.  Do not exceed 30oC (86oF)

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

  • Inactive ingredient

    Inactive ingredient  hydrogenated vegetable oil

  • Directions

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

    adults and children 12 years of age and older            1 suppository once daily
    children 6 to under 12 years                                       1/2 suppository once daily
    children under 6 years                                                do not use

  • Label

    Product Label

  • INGREDIENTS AND APPEARANCE
    WALGREENS GENTLE LAXATIVE 
    bisacodyl suppository suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0466
    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) 1990 mg  in 2000 mg
    Product Characteristics
    ColorwhiteScore    
    ShapeBULLETSize32mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0466-315 in 1 PACKAGE09/18/2014
    1NDC:0363-0466-3060 mg in 1 CARTRIDGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/18/2014
    Labeler - Walgreens (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(0363-0466)