1. Home
  2. Labeler Index
  3. C.b. Fleet Company, Inc.
  4. 0132-0655
  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. ASK A DOCTOR BEFORE USING ANY LAXATIVE IF CHILD HAS
    5. STOP USE AND CONSULT A DOCTOR IF YOUR CHILD HAS
    6. KEEP OUT OF REACH OF CHILDREN TO PREVENT ACCIDENTAL INGESTION.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS?
    11. 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



Magnesium hydroxide 400 mg


Purpose



Saline laxative


Uses



  • for relief of occasional constipation
  • this product usually produces bowel movement in 1/2 to 6 hours

Ask A Doctor Before Using Any Laxative If Child Has



  • kidney disease
  • a magnesium-restricted diet
  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits lasting more than 2 weeks
  • constipation continues after 1 week of use, contact your child's doctor
  • already used a laxative for more than 1 week

Stop Use And Consult A Doctor If Your Child Has



  • rectal bleeding
  • no bowel movement within 6 hours 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



Use dosage chart for proper dosing. Doses may be taken as a single daily dose or in divided doses. Drink a full glass (8 ounces) of liquid with each dose.

AgeStarting doseStarting Dose Maxiumm dose per day (24 hours)
children 6 to under 12 years3-6 tablets6 tablets
children 2 to under 6 years 1-3 tablets 3 tablets 
children under 2 yearsask a doctor


Other Information



  • each tablet contains: 170 mg of magnesium
  • CHILD RESISTANT CAP
  • The top of the bottle sealed for safety.Do not use if foil impreinted "SEALED for YOUR PROTECTION" is broken of missing.
  • Gluten Free and Sugar Free

Inactive Ingredients



colloidal silicon dioxide, FD&C red #40 aluminum lake, flavor, magnesium stearate, maltodextrin, mannitol, sorbitol, stearic acid, sucralose


Questions?



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


Principal Display Panel



Pedia-Lax Chewable Tablets

Saline Laxative

30 chewable tablets


* Please review the disclaimer below.