Label: DOCU LIQUID- docusate sodium liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 24, 2024

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  • Active ingredient

    Docusate Sodium 50 mg

  • Purpose

    Stool Softener Laxative

  • Keep Out of Reach of Children

  • Uses

    relieves occasional constipation
    generally produces bowel movement in 12-72
  • Warnings

    Do Not Use

    if you are presently taking mineral oil
    when abdominal pain, nausea, or vomiting are present
    for longer than one week

    Ask a doctor before use if you have

    noticed a sudden change in bowel habits that lasts over two weeks.

    Ask a doctor or pharmacist before use if you are

    taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

    Stop use and ask a doctor if

    you have rectal bleeding
    you fail to have a bowel movement after use of this product

    These may indicate a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep Out of Reach of Children

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    may be taken once daily or in divided doses
    give dose in 1/2 glass of milk, fruit juice or infant formula to mask bitter taste and prevent throat irritation

    adults and children over 12

    1 to 7 teaspoons

    children 2 to under 12

    1 to 3 teaspoons

    children under 2

    ask a doctor

  • Other information

    each teaspoon contains: sodium 5 mg
    shake well before using
    store at controlled room temperature 15° - 30°C (59° - 86°F)
    dispense contents with a child resistant closure in a tight, light resistant container as defined in the USP
    store in an upright position
  • Inactive Ingredients

    D&C Red #33, methylparaben, natural & artificial vanilla flavor, poloxamer 181, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium benzoate. Sodium citrate may be used to adjust pH.

  • Questions or comments?

    DISTRIBUTED BY: 

    ATLANTIC BIOLOGICALS CORP.

    20101 N.E 16TH PLACE 

    MIAMI, FL 33179   

  • Package/Label Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    DOCU LIQUID 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0771(NDC:50383-771)
    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
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 181 (UNII: 09Y8E6164A)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorVANILLA (natural and artificial flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0771-150 in 1 BOX, UNIT-DOSE05/24/2024
    125 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:17856-0771-272 in 1 BOX, UNIT-DOSE05/24/2024
    210 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM08/01/1997
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    UNIT DOSE SOLUTIONS360804194repack(17856-0771)