Label: DOCUSATE SODIUM liquid

  • Category: HUMAN OTC DRUG LABEL

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 January 3, 2012

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  • Active ingredient (in each teaspoon)

    Docusate Sodium 50 mg

  • Purpose

    Stool Softener Laxative

  • Uses

    • relieves occasional constipation
    • generally produces bowel movement in 12-72 hours
  • 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 121 to 7 teaspoons
      children 2 to under 121 to 3 teaspoons
      children under 2ask 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.
  • Inactive ingredients

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

     

  • Questions or comments?

    • Call 1-800-262-9010

      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. 771:04 07/10

  • PRINCIPAL DISPLAY PANEL

    DOCU LIQUID

    (Docusate Sodium 50 mg/5 mL)

    NDC 54868-6209-0

    NET CONTENTS ONE PINT (473 mL)

    Image of Container Label - 473 mL

    STOOL SOFTENER LAXATIVE

     
    TAMPER EVIDENT: FOR YOUR PROTECTION, THIS BOTTLE HAS A SAFETY SEAL AROUND THE NECK OR UNDER THE CAP.

     

    Hi-Tech Pharmacal Co., Inc.

    Amityville, NY 11701

     


    Additional bar code labeling by:
    Physicians Total Care, Inc.
    Tulsa, Oklahoma        74146

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-6209(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 4000 (UNII: 4R4HFI6D95)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    VANILLA (UNII: Q74T35078H)  
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 181 (UNII: 09Y8E6164A)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-6209-0473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/07/2010
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel
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