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
  • 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 June 6, 2023

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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 not finalpart33402/01/2020
    Labeler - C.B. Fleet Company, Inc. (003119054)
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