Label: DOCUSATE SODIUM LIQUID- docusate sodium liquid

  • NDC Code(s): 54859-813-16
  • Packager: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 27, 2024

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  • ACTIVE INGREDIENT

    Active Ingredients (per 5 mL)

    Docusate Sodium 50 mg

  • PURPOSE

    Purpose

    Stool Softener

  • INDICATIONS & USAGE

    Uses

    Relief of occasional constipation

  • WARNINGS

    Warnings

    Do not use when

    • abdominal pain, nausea, or vomiting are present unless directed by a doctor
    • for more than one week unless directed by a doctor

    Ask a doctore before use if you

    • are taking mineral oil
    • have noticed a sudden change in bowel habits that last more than two weeks

    Stop use and ask doctor if

    • you have no bowel movements within 3 days
    • you have rectal bleeding
    • these could be signs of a serious condition
    • a skin rash occurs
    • you experience throat irritation
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a doctor before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental overdose, seek medical assistance or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • follow dosing directions below or use as directed by a physician
    • must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation
    • may be taken as a single daily dose or in dividend dose
    • take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
    • do not exceed recommended dose
    • shake well before using

    1 teasponnful = 5 mL

     Age Dose
     Adults and children over 12 years of age 1 to 6 teaspoons (50 mg - 300 mg)
     Children under 12 years of age Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, sodium benzoate, sodium citrate, sucralose

  • QUESTIONS

    Questions or comments? 1-866-595-5598

  • PRINCIPAL DISPLAY PANEL

    Ducosate

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM LIQUID 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-813
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54859-813-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00712/01/2021
    Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)