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Pedia-Lax (C.B. Fleet Company, Inc.)

Available Formats

Dosage Form Package Information Links
ENEMA 66 mL in 1 BOTTLE, WITH APPLICATOR (0132-0202-20) Label Information

Complete Pedia-Lax Information

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

    Monobasic Sodium Phosphate 9.5 g, Saline Laxative

    Dibasic Sodium Phosphate 3.5 g, Saline Laxative


  • Use

    For relief of occasional constipation.


  • Warnings

    For rectal use only

    Dosage Warning:

    Using more than one enema in 24 hours can be harmful. Do not use ├»┬╗┬┐without asking a doctor:

    • for more than 3 days
    • if your child has kidney disease
    • if your child has heart problems
    • if your child is dehydrated

  • Ask a doctor before using this product if the child

    • is on a sodium-restricted diet


    Ask a doctor before using any laxative if your 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 ask a doctor if the child has

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

    These symptoms may indicate a serious condition.


  • Keep out of reach of children to prevent accidental ingestion.

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


  • Directions

    Single Daily Dosage (per 24 hours)


    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 per day or as directed by a doctor
    children 2 to under 5 years one-half bottle per day (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 "How to use this enema" directions.


  • Other Information

    • each 59-mL delivered dose contains: sodium 2.2 g
    • additional liquids by mouth are recommended while taking this product
    • this product generally produces a bowel movement in 1-5 minutes
    • BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET EMBLEM IS TORN, DAMAGED OR MISSING, DO NOT USE
    • for complete professional use warnings and precautions, consult the Reference Safety Information on our website

  • Inactive Ingredients

    benzalkonium chloride, disodium EDTA, purified water


  • Questions?

    1-866-255-6960

    www.pedia-lax.com


  • INGREDIENTS AND APPEARANCE
    PEDIA-LAX 
    sodium phosphate, dibasic and sodium phosphate, monobasic enema
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0202
    Route of Administration RECTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 3.5 g  in 66 mL
    sodium phosphate, monobasic (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) sodium phosphate, monobasic 9.5 g  in 66 mL
    Inactive Ingredients
    Ingredient Name Strength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0132-0202-20 66 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 05/10/2002
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 05/10/2002
    Labeler - C.B. Fleet Company, Inc. (003119054)
    Establishment
    Name Address ID/FEI Business Operations
    C.B. Fleet Company, Inc. 003119054 manufacture(0132-0202)