Label: PEDIA-LAX- magnesium hydroxide tablet, chewable

  • NDC Code(s): 0132-0655-01
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 11, 2024

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  • SPL UNCLASSIFIED SECTION

    Pedia-Lax Chewable Tablets

    Drug Facts

  • Active Ingredient (in each tablet)

    Magnesium hydroxide 400 mg

  • Purpose

    Saline laxative

  • Uses

    • For relief of occasional constipation
    • This product usually produces abowel movement in 1/2 to 6 hours
  • Warnings

  • 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 that continues after 1 week of use, contact your child's doctor 
    • already used a laxative for more than 1 week

    Stop using this product and consult a doctor if your child

    • has rectal bleeding
    • does not have a bowel movement within 6 hours of using this product 
    • these symptoms maybe signs of a serious condition

    Keep out of reach of children.

    In case of overdose, get medical help or contact Poison Control Center (1-800-222-1222) 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 Maximum dose per day (24 hours)
    children 6 to under 12 years3-6 tablets6 tablets
    children 2 to under 6 years1-3 tablets3 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 imprinted "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®
    Magnesium hydroxide
    Chewable Laxative
    30 chewable tablets

    Pedia-Lax® Magnesium hydroxide Chewable Laxative 30 chewable tablets

  • INGREDIENTS AND APPEARANCE
    PEDIA-LAX 
    magnesium hydroxide tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0655
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S) (MAGNESIUM CATION - UNII:T6V3LHY838, HYDROXIDE ION - UNII:9159UV381P) MAGNESIUM HYDROXIDE400 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorpinkScore2 pieces
    ShapeROUNDSize14mm
    FlavorWATERMELONImprint Code Pedia;Lax
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0655-011 in 1 CARTON03/01/2008
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00703/01/2008
    Labeler - C.B. Fleet Company, Inc. (003119054)
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