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
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 June 26, 2023

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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 not finalpart33405/10/2002
    Labeler - C.B. Fleet Company, Inc. (003119054)
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