Label: PEDIA-LAX- docusate sodium liquid

  • NDC Code(s): 0132-0113-24
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 1, 2024

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

  • 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

    years

    15 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)

    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:0132-0113
    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:0132-0113-24118 mL in 1 CARTON; Type 0: Not a Combination Product02/28/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00702/28/2023
    Labeler - C.B. Fleet Company, Inc. (003119054)