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

  • NDC Code(s): 0132-0201-10
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

If you are a consumer or patient please visit this version.

  • Active Ingredient (in each 197-mL delivered dose)

    Monobasic Sodium Phosphate 19 g.................Saline Laxative

    Dibasic Sodium Phosphate 7 g........................Saline Laxative Close
  • Use

    For relief of occasional constipation.

    Close
  • Warnings

    For rectal use only.


    Using more than one enema in 24 hours can be harmful.
    Close
  • 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 
    Close
  • Stop use and consult a doctor if the child has

    • rectal bleeding
    • no bowel movement within 30 minutes of enema use
    • symptoms of dehydration (feeling thirsty, dizziness, vomiting or urinating less often than normal)
    These symptoms may indicate a serious condition.
    Close
  • Keep out of reach of children

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

    Close
  • Directions

    Single Daily Dosage


    Do not use more unless directed by a doctor. See Warnings. Do not use if child is taking another sodium phosphates product.

    children 5 to 11 years
    1 bottle or as directed by a doctor
    children 2 to under 5 years
    one-half bottle (see below)
    children under 2 years
    DO NOT USE
    One-half bottle prepararation:
    Unscrew cap and remove 2 tablespoons of liquid with a measuring spoon. Replace cap and follow directions.
    Close
  • Other Information

    • each 197-mL delivered dose contains: sodium 4.4 g
    • additional liquids by mouth are recommended while taking this product
    • this product generally produces a bowel movement in 1-5 minutes
    • carton sealed for safety. If seal with Fleet emblem on top or bottom flap is broken or missing, do not use
    • for complete professional use warnings and precautions, consult Physicians' Desk Reference
    Close
  • Inactive Ingredients

    benzalkonium chloride, disodium EDTA, purified water

    Close
  • Questions?

    1-866-255-6960 or www.pedia-lax.com

    Close
  • INGREDIENTS AND APPEARANCE
    FLEET 
    sodium phosphate, dibasic and sodium phosphate, monobasic enema
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0132-0201
    Route of Administration RECTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (PHOSPHATE ION and SODIUM CATION) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 7 g  in 230 mL
    sodium phosphate, monobasic (SODIUM CATION and PHOSPHATE ION) sodium phosphate, monobasic 19 g  in 230 mL
    Inactive Ingredients
    Ingredient Name Strength
    EDETATE DISODIUM  
    WATER  
    BENZALKONIUM CHLORIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0132-0201-10 230 mL in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 06/25/2004
    Labeler - C.B. Fleet Company, Inc. (003119054)
    Establishment
    Name Address ID/FEI Business Operations
    C.B. Fleet Company, Inc. 003119054 manufacture(0132-0201)
    Close