Label: FLEET- sodium phosphate, dibasic and sodium phosphate, monobasic enema

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 23, 2015

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  • Active Ingredient (in each 118-mL delivered dose)

    Monobasic Sodium Phosphate 19 g.................Laxative / Bowel Cleanser

    Dibasic Sodium Phosphate 7 g........................Laxative / Bowel Cleanser

  • Use

    For relief of occasional constipation or bowel cleansing before rectal examinations.

  • Warnings

    Using more than one enema in 24 hours can be harmful.

  • Ask a doctor before using this product if you

    • are on a sodium-restricted diet
    • have kidney disease
    • are pregnant or nursing a baby

    Ask a doctor before using any laxative if you:

    • have abdominal pain, nausea, or vomiting
    • have a sudden change in bowel habits lasting more than 2 weeks
    • have already used a laxative for more than 1 week
  • Stop using this product and consult a doctor if you

    • have rectal bleeding
    • have no bowel movement after the enema is given

    These symptoms may indicate a serious condition.

  • Keep out of reach of children

    In case of overdose or accidental ingestion, get medical help right away.

  • Directions

     Single Daily Dosage: Do not use more unless directed by a doctor. See Warnings.
     Adults and children 12 years and over    One Bottle
     Children 2 to 11 years Use Fleet Enema for Children
     Children under 2 years DO NOT USE

  • Other Information

    Sodium Content 4.4 g

  • Inactive Ingredients

    benzalkonium chloride, disodium EDTA, purified water

  • Questions?

    C.B. Fleet Co., Inc.

    Lynchburg, VA 24502

    U.S.A.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FLEET 
    sodium phosphate, dibasic and sodium phosphate, monobasic enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0541
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE7 g  in 133 mL
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC19 g  in 133 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0541-40133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    export only05/01/2010
    Labeler - C.B. Fleet Company, Inc. (003119054)
    Establishment
    NameAddressID/FEIBusiness Operations
    C.B. Fleet Company, Inc.003119054manufacture(0132-0541)
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