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

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 September 29, 2017

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

  • Active Ingredients

    (in each tablespoon)

    Docusate sodium 50 mg, Stool softener

  • Uses

    • for the prevention of dry, hard stools
    • for relief of occasional constipation
    • this product generally produces bowel movement in 12-72 hours
  • 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
    • if constipation continues after 1 week of use, contac your child's doctor
  • Stop using this product and consult a doctor if your child has

    • rectal bleeding
    • no bowel movement within 72 horus of using this product

    These symptoms may be signs of a serious condition.

  • Keep out of reach of children

    In case of overdose, 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. Doses can be given in a glass of juice to prevent throat irritation and to help mask the naturally tart flavor of the active ingredient.

     Age Starting Dose

     Maximum dose per day (24 hours)

     children 2 to 12 years 1 - 3 tablespoons 3 tablespoons
     children under 2 years ask a doctor

  • 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.
    • Gluten Free
  • 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

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Pedia-Lax Liquid Stool Softener Carton

  • INGREDIENTS AND APPEARANCE
    PEDIA-LAX 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0106
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XYLITOL (UNII: VCQ006KQ1E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POVIDONE (UNII: FZ989GH94E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorFRUIT PUNCHImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0106-24118 mL in 1 CARTON; Type 0: Not a Combination Product03/01/2008
    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)
    Establishment
    NameAddressID/FEIBusiness Operations
    C.B. Fleet Company, Inc.003119054manufacture(0132-0106)