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

  • NDC Code(s): 0132-0201-40, 0132-0201-42, 0132-0201-45
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 19, 2024

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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

    Saline laxative

    Saline laxative

  • Use

    for relief of occasional constipation. This product usually produces a bowel movement in 1 to 5 minutes.

  • Warnings

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

    For rectal use only.

    Do not use

    • for more than 3 days
    • if you have kidney disease
    • if you have heart problems
    • if you are dehydrated
    • when abdominal pain, nausea, or vomiting are present unless directed by a doctor

    Ask a doctor before using this product if you

    • are 55 years of age or older
    • are on a sodium-restricted diet
    • have a sudden change in bowel habits lasting more than 2 weeks
    • already used a laxative for more than 1 week  

    Stop use and ask a doctor if you have

    • rectal bleeding
    • no bowel movement or no liquid comes out of the rectum after 30 minutes
    • symptoms of dehydration [feeling thirsty, dizziness, vomiting, urinating less often than normal]

    These symptoms may indicate a serious condition.

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Single Daily Dosage (per 24 hours)  
    Do not use if taking another sodium phosphates product.  
    Do not use more unless directed by a doctor. See Warnings.
    adults and children 12 years and over     1 bottle per day
    children 2 to 11 yearsuse Fleet® Pedia-Lax® Enema
    children under 2 yearsDO NOT USE
    If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.
  • Other Information

    • each 118 mL delivered dose contains: sodium 4.4 g
    • additional liquids by mouth are recommended while taking this product
  • Inactive Ingredients

    benzalkonium chloride, disodium EDTA, purified water

  • Questions?

    1-866-255-6960 or www.fleetlabs.com

    Tamper Evident: Do not use if imprinted seal on bottom flap or top flap is broken or missing.

  • PRINCIPAL DISPLAY PANEL

    Fleet ®
    Laxative
    Saline Enema
    1 Bottle 4.5 Fl Oz (133 mL)

    Fleet ® Laxative Saline Enema 1 Bottle 4.5 Fl Oz (133 mL)

  • INGREDIENTS AND APPEARANCE
    FLEET 
    sodium phosphate, dibasic and sodium phosphate, monobasic enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0201
    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 118 mL
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, MONOBASIC19 g  in 118 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:0132-0201-40133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/15/2017
    2NDC:0132-0201-42133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/15/2017
    3NDC:0132-0201-45133 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00703/10/1953
    Labeler - C.B. Fleet Company, Inc. (003119054)
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