Label: PEDIA-LAX- docusate sodium liquid

  • NDC Code(s): 0132-0107-24
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 16, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    (in each 15 mL)

    Docusate Sodium 50 mg

  • Purpose

    Stool softener

  • Uses

    • for prevention of dry, hard stools
    • for relief of occasional constipation
    • this product usually produces a bowel movement in 12 to 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

    • 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, contact your child's doctor

    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.

    Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • do not give more than 45 mL in any 24 hour period
    • use only with enclosed dosing cup
    • find right dose on chart below
    • mL = milliliter
     Age Dose
     Children 2 to under 12 years15 mL to 45 mL; do not take more than 45 mL in 24 hours
     Children under 2 years ask a doctor

    Doses can be diluted in a suitable beverage to prevent throat irritation and to help mask the naturally tart flavor of the active ingredient (see side panel for info).

  • Other information

    • each 15 mL contains: sodium 13 mg
    • 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, 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
    Docusate sodium
    Liquid Stool Softener
    4 fl oz (118 mL)

    Pedia-Lax Docusate sodium Liquid Stool Softener 4 fl oz (118 mL)

  • INGREDIENTS AND APPEARANCE
    PEDIA-LAX 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0107
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Colorwhite (Colorless) Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0107-24118 mL in 1 CARTON; Type 0: Not a Combination Product02/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00702/01/2020
    Labeler - C.B. Fleet Company, Inc. (003119054)
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