Label: DOCU LIQUID- docusate sodium liquid

  • 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 October 13, 2022

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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?

    •
    Call 1-800-932-5676

    Mon - Thurs. 9:00 am - 4:30 pm EST, Fri. 9:00 am - 2:30 pm EST.

    Serious side effects associated with use of this product may be reported to this number.

  • Package/Label Principal Display Panel

    container label

    NDC 50383-771-16

    DOCU LIQUID

    (Docusate Sodium 50 mg/5 mL)

    STOOL SOFTENER LAXATIVE

    TAMPER EVIDENT: FOR YOUR PROTECTION THE CHILD RESISTANT CAP HAS A PRINTED SAFETY SEAL AROUND THE NECK. DO NOT ACCEPT IF BROKEN OR MISSING.

    Distributed by:

    Akorn Operating Company LLC

    Gurnee, IL 60031

    NET CONTENTS ONE PINT (473 mL)

  • Package/Label Principal Display Panel

    Unit Dose Lid

    Delivers 10 mL

    NDC 50383-349-10

    DOCU LIQUID

    (DOCUSATE SODIUM)

    100 mg/ 10 mL

    STOOL SOFTENER LAXATIVE

    SEE INSERT

    Barcode 3 5038334910 5

    FOR INSTITUTIONAL USE ONLY

    Distributed by:

    Akorn Operating Company LLC

    Gurnee, IL 60031

    Rev. 349:01 04/22

  • INGREDIENTS AND APPEARANCE
    DOCU LIQUID 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:50383-771-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/01/1997
    DOCU LIQUID 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50383-349
    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:50383-349-1110 in 1 CASE05/28/2021
    110 in 1 TRAY
    1NDC:50383-349-1010 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 not finalpart33408/01/1997
    Labeler - Akorn Operating Company LLC (117696873)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn Operating Company LLC117696873MANUFACTURE(50383-771, 50383-349) , PACK(50383-771, 50383-349)
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