Label: PEDIA-LAX- magnesium hydroxide tablet, chewable

  • NDC Code(s): 0132-0655-01
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 30, 2017

If you are a consumer or patient please visit this version.

  • 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
  • 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 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

    Pedia-Lax Chewable Tablets 30 ct carton

  • 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 not finalpart33403/01/2008
    Labeler - C.B. Fleet Company, Inc. (003119054)