Label: DOCU- 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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

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

  • Active ingredient (in each teaspoon)

    Docusate Sodium 50 mg

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  • Purpose

    Stool Softener Laxative

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  • Use

    • relieves occasional constipation
    • generally produces bowel movement in 12-72 hours
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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. 771:06 02/13

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  • PRINCIPAL DISPLAY PANEL

    Docu liquid_label_16 oz

    NDC 50383-771-16

    DOCU LIQUID

    (Docusate Sodium 50 mg/5 mL)

    STOOL SOFTENER LAXATIVE

      

    TAMPER EVIDENT: CAP SEALED WITH BREAKAWAY BAND AROUND BOTTLE 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 
    docusate sodium liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50383-771
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 50 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 33  
    METHYLPARABEN  
    POLYETHYLENE GLYCOL 4000  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    SODIUM BENZOATE  
    SODIUM CITRATE  
    WATER  
    POLOXAMER 181  
    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
    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
    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)
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