Label: DOCU LIQUID- docusate sodium liquid

  • NDC Code(s): 50383-771-10, 50383-771-11, 50383-771-16
  • Packager: Hi-Tech Pharmacal Co., 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 December 29, 2015

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

  • Active ingredient

    Docusate Sodium 50 mg

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  • Purpose

    Stool Softener Laxative

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  • Keep Out of Reach of Children
  • Uses

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

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  • 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

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  • 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
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  • 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.

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  • Questions or comments?

    Call 1-800-262-9010

    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.

    REV. 771:07 02/14

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  • Package/Label Principal Display Panel

    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.

    Hi-Tech Pharmacal Co., Inc.

    Amityville, NY 11701

    NET CONTENTS ONE PINT (473 mL)

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  • INGREDIENTS AND APPEARANCE
    DOCU LIQUID 
    docusate sodium liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50383-771
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color PINK Score     
    Shape Size
    Flavor VANILLA (natural and artificial vanilla flavor) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50383-771-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:50383-771-11 10 in 1 CASE
    2 10 in 1 TRAY
    2 NDC:50383-771-10 10 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 08/01/1997
    Labeler - Hi-Tech Pharmacal Co., Inc. (101196749)
    Establishment
    Name Address ID/FEI Business Operations
    Hi-Tech Pharmacal Co., Inc. 101196749 MANUFACTURE(50383-771)
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