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  5. Label Information: Pedia-lax

FDA Label for Pedia-lax

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USING ANY LAXATIVE IF CHILD HAS
    6. STOP USE AND CONSULT A DOCTOR IF CHILD HAS
    7. KEEP OUT OF REACH OF CHILDREN TO PREVENT ACCIDENTAL INGESTION.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. 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



Glycerin 1 g


Purpose



Hyperosmotic Laxative


Uses



  • for relief of occasional constipation
  • this product usually 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 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 Consult A Doctor If 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 To Prevent Accidental Ingestion.



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 years

 1 suppository or as

directed by a doctor

 children under 2 years ask a doctor

Insert suppository well up into rectum. To produce laxative action suppository is designed to dissolve only partially, which may not be noticeable.


Other Information



  • Store container tightly closed.
  • Keep away from excessive heat.
  • Mouth of jar sealed for safety. If foil imprinted with green Fleet® emblem is missing or torn, do not use.

Inactive Ingredients



aloe vera gel (decolorized), edetate disodium, purified water, sodium hydroxide, stearic acid


Questions?



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


Principal Display Panel



Pedia-Lax Glycerin Suppositories

12 suppositories


* Please review the disclaimer below.