Label: PEDIA-LAX- docusate sodium liquid

  • NDC Code(s): 0132-0106-24
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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

  • Active Ingredient

    (in each tablespoon)

    Docusate Sodium 50 mg

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  • Uses

    • for the prevention of dry, hard stools
    • for relief of occasional constipation
    • this product generally produces bowel movement in 12-72 hours
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  • Warnings

    Drug interaction precaution: do not give this product to your child if your child is presently taking mineral oil unless directed by a doctor.

    Ask a doctor before using any laxative if your 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
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  • Stop using this product and consult a doctor if your child has

    • rectal bleeding
    • no bowel movement within 72 hours of using this product
    These symptoms may be signs of a serious condition.
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  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    Use dosage chart for proper dosing. Doses may be taken as a single daily dose or in divided doses. Doses must be given in a 6-8 oz glass of milk or juice, to prevent throat irritation.

    Age
    Starting Dose
    Maximum Dose per Day
    children 2 to under 12 years
    1 - 3 tablespoons
    3 tablespoons
    children under 2 years
    ask a doctor


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  • Other Information


    • each tablespoon contains: sodium 13 mg
    • CHILD RESISTANT CAP
    • The top of the bottle is sealed with foil for your safety. Do not use if foil imprinted "SEALED for YOUR PROTECTION" is broken or missing.
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  • Inactive Ingredients

    citric acid, edetate disodium, FD and C red 3, flavor, methylparaben, polyethylene glycol, povidone, propylene glycol, propylparaben, sodium citrate, sorbitol, sucralose, water, xanthan gum, xylitol

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  • Questions?

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

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  • INGREDIENTS AND APPEARANCE
    PEDIA-LAX 
    docusate sodium liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0132-0106
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg  in 118 mL
    Inactive Ingredients
    Ingredient Name Strength
    EDETATE DISODIUM  
    XYLITOL  
    XANTHAN GUM  
    WATER  
    SUCRALOSE  
    SORBITOL  
    SODIUM CITRATE  
    POVIDONE  
    METHYLPARABEN  
    PROPYLENE GLYCOL  
    ANHYDROUS CITRIC ACID  
    FD&C RED NO. 3  
    POLYETHYLENE GLYCOL 4500  
    PROPYLPARABEN  
    Product Characteristics
    Color pink Score     
    Shape Size
    Flavor FRUIT PUNCH Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0132-0106-24 118 mL in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 03/01/2008
    Labeler - C.B. Fleet Company, Inc. (003119054)
    Establishment
    Name Address ID/FEI Business Operations
    C.B. Fleet Company, Inc. 003119054 manufacture(0132-0106)
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