Label: STOOL SOFTENER- docusate sodium capsule, liquid filled

  • NDC Code(s): 11673-238-01, 11673-238-16
  • Packager: Target Corporation
  • 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 07/13

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

  • Active ingredient (in each softgel)

    Docusate sodium 100 mg

    Purpose

    Stool softener laxative

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  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 12 to 72 hours
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  • Warnings

    Do not use

    if you are presently taking mineral oil, unless told to do so by a doctor.

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that lasts over 2 weeks

    Stop use and ask a doctor if

    • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
    • you need to use a laxative for more than 1 week

    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

    • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
     adults and children 12 years and over   take 1-3 softgels daily
     children 2 to under 12 years of age  take 1 softgel daily
     children under 2 years  ask a doctor
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  • Other information

    • each softgel contains: sodium 6 mg
    • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
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  • Inactive ingredients

    D&C red #33*, D&C yellow #10*, edible ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, lecithin*, medium-chain triglycerides*, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

    *contains one or more of these ingredients

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  • Questions or comments?

    Call 1-800-910-6874

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  • Principal Display Panel

    Compare to active ingredient in Colace®**    

    Stool Softener

    Docusate Sodium 100 mg

    for fast, dependable relief of occasional constipation

    SOFTGELS

    **This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.

    Dist. by Target Corporation

    Minneapolis, MN 55403

    Shop Target.com

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

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  • Product Labeling

    Docusate sodium 100 mg

    Target Stool Softener Softgel

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  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11673-238
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 33  
    D&C YELLOW NO. 10  
    FD&C BLUE NO. 1  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    GELATIN  
    GLYCERIN  
    EGG PHOSPHOLIPIDS  
    MEDIUM-CHAIN TRIGLYCERIDES  
    POLYETHYLENE GLYCOLS  
    PROPYLENE GLYCOL  
    WATER  
    SORBITAN  
    SORBITOL  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color RED, WHITE Score no score
    Shape OVAL Size 12mm
    Flavor Imprint Code P10;S78;SCU2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11673-238-01 100 in 1 BOTTLE, PLASTIC
    2 NDC:11673-238-16 160 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 07/15/2013
    Labeler - Target Corporation (006961700)
    Registrant - P and L Development of New York Corporation (800014821)
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