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

  • NDC Code(s): 0132-0554-40
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated November 10, 2021

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  • SPL UNCLASSIFIED SECTION

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

    Monobasic Sodium Phosphate 19 g................

    Dibasic Sodium Phosphate 7 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 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

    Fleet
    SODIUM PHOSPHATES
    ENEMA USP
    FOR RELIEF OF CONSTIPATION
    ACTS WITHIN MINUTES
    REGULAR
    130 ml

    Fleet SODIUM PHOSPHATES ENEMA USP FOR RELIEF OF CONSTIPATION ACTS WITHIN MINUTES REGULAR 130 ml

  • INGREDIENTS AND APPEARANCE
    FLEET 
    sodium phosphate, dibasic and sodium phosphate, monobasic enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0554
    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
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0554-40133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/1954
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only01/01/1954
    Labeler - C.B. Fleet Company, Inc. (003119054)
    Establishment
    NameAddressID/FEIBusiness Operations
    C.B. Fleet Company, Inc.003119054manufacture(0132-0554)
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