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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 2.7 ML AVERAGE DELIVERED DOSE)
    2. USES
    3. WARNINGS
    4. ASK A DOCTOR BEFORE USING ANY LAXATIVE IF THE CHILD HAS
    5. STOP USING THIS PRODUCT AND CONSULT A DOCTOR IF THE CHILD HAS
    6. KEEP OUT OF REACH OF CHILDREN
    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 2.7 Ml Average Delivered Dose)



Glycerin 2.8 g, Hyperosmotic Laxative


Uses



  • For relief of occasional constipation
  • This product generally produces bowel movement in 1/4 to 1 hour

Warnings



For rectal use only

May cause rectal discomfort or a burning sensation.


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
  • if constipation continues after one week of use, contact your child's doctor

Stop Using This Product And Consult A Doctor If The Child Has



  • rectal bleeding
  • no bowel movement within 1 hour of using this product

    • These symptoms may indicate a serious condition.


Keep Out Of Reach Of Children



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


Directions



Single daily dosage (per 24 hours)

 children 2 to under 6 years1 suppository, or as directed by a doctor
 children under 2 yearsconsult a doctor


Other Information



  • carton sealed for safety. If seal with Fleet emblem on bottom flap or top flap is broken or missing, do not use.

Inactive Ingredients



edetate disodium, purified water


Questions?



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


Package Label.Principal Display Panel



Pedia-Lax Liquid Glycerin Suppositories Carton - PediaLaxLiquidGlycerinSuppositoriesCarton

Pedia-Lax Liquid Glycerin Suppositories Carton - PediaLaxLiquidGlycerinSuppositoriesCarton


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