Label: PEDIA-LAX- sodium phosphate, dibasic and sodium phosphate, monobasic enema

  • NDC Code(s): 0132-0202-20
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • SPL UNCLASSIFIED SECTION

    PEDIA-LAX sodium phosphates Saline Enema
    C.B. Fleet Company, Inc.

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    Drug Facts

  • Active Ingredients

    (in each 59-mL delivered dose)

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

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

  • Purpose

    Saline laxative

    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 a 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 your 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, 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 per day unless directed by a doctor. See Warnings.
    Do not use if child is taking another sodium phosphates product.  

     Age Dose
     children 5 to 11 years 1 bottle per day or as directed by doctor
    children 2 to under 5 years one-half bottle per day (see below)
     children under 2 years DO NOT USE

    One-half bottle preparation:
    Unscrew cap and remove 2 tablesppons 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 2.2g
    • additional liquids by mouth are recommended while taking this product
    • this product usually 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

    Fleet®  Enemas are LATEX-FREE

  • PRINCIPAL DISPLAY PANEL

    Pedia-Lax
    Sodium Phosphates  
    Saline Enema
    2.25 fl oz (66 mL)

    PRINCIPAL DISPLAY PANEL Pedia-Lax Sodium Phosphates Saline Enema 2.25 fl oz (66 mL)

  • INGREDIENTS AND APPEARANCE
    PEDIA-LAX 
    sodium phosphate, dibasic and sodium phosphate, monobasic enema
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0202
    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) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) sodium phosphate, monobasic9.5 g  in 66 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:0132-0202-2066 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product05/10/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00705/10/2002
    Labeler - C.B. Fleet Company, Inc. (003119054)
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