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

  • NDC Code(s): 0132-0555-20
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated November 12, 2021

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredient (in each 59-mL delivered dose)

    Monobasic Sodium Phosphate 9.5 g.................

    Dibasic Sodium Phosphate 3.5 g......................

  • Purpose

    Laxative / Bowel Cleanser

    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 the child

    • is on a sodium-restricted diet
    • has kidney disease

    Ask a doctor before using any laxative if the child has:

    • abdominal pain, nausea, or vomiting
    • a sudden change in bowel habits lasting more than 2 weeks
    • already used a laxative for more than 1 week

    Stop use and consult a doctor if the child has

    • rectal bleeding
    • no bowel movement ater 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.

    Other Information

  • Inactive Ingredients

    benzalkonium chloride, disodium EDTA, purified water

  • Questions?

    C.B. Fleet Co., Inc.

    Lynchburg, VA 24502

    U.S.A.

  • Directions

    Do not use more unless directed by a doctor. See Warnings  
     children 5 to 11 years One bottle or as directed by a doctor
     children 2 to under 5 years One-half bottle
     children under 2 years DO NOT USE
  • PRINCIPAL DISPLAY PANEL

    Fleet
    SODIUM PHOSPHATES
    ENEMA USP
    ACTS WITHIN MINUTES
    FOR CHILDREN
    65 ML

    Fleet SODIUM PHOSPHATES ENEMA USP ACTS WITHIN MINUTES FOR CHILDREN 65 ML

  • INGREDIENTS AND APPEARANCE
    FLEET FOR CHILDREN 
    sodium phosphate, dibasic and sodium phosphate, monobasic enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0555
    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, HEPTAHYDRATE3.5 g  in 66 mL
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC9.5 g  in 66 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0555-2066 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/1980
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only01/01/1980
    Labeler - C.B. Fleet Company, Inc. (003119054)
    Establishment
    NameAddressID/FEIBusiness Operations
    C.B. Fleet Company, Inc.003119054manufacture(0132-0555)
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