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  5. Label Information: Pedia-lax

FDA Label for Pedia-lax

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 59-ML DELIVERED DOSE)
    2. USE
    3. WARNINGS
    4. ASK A DOCTOR BEFORE USING THIS PRODUCT IF THE CHILD
    5. STOP USE AND ASK A DOCTOR IF THE CHILD HAS
    6. KEEP OUT OF REACH OF CHILDREN TO PREVENT ACCIDENTAL INGESTION.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS?
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pedia-lax Product Label

The following document was submitted to the FDA by the labeler of this product C.b. Fleet Company, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 years1 bottle per day or as directed by a doctor
children 2 to under 5 yearsone-half bottle per day (see below)
children under 2 yearsDO 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


* Please review the disclaimer below.