WALGREENS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [WALGREENS]

WALGREENS GENTLE LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [WALGREENS]
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NDC 0363-0466-08, 0363-0466-09
Set ID d094ba43-7404-43c4-b907-41ab6d02a3c3
Category HUMAN OTC DRUG LABEL
Packager Walgreens
Generic Name
Product Class
Product Number
Application Number PART334
  • 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:0363-0466-092 in 1 PACKAGE09/18/2014
    1NDC:0363-0466-0840 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 not finalpart33409/18/2014
    Labeler - Walgreens (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack, Inc.009248480manufacture(0363-0466)

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