Label: STOOL SOFTENER- docusate sodium capsule, liquid filled 

  • Label RSS
  • NDC Code(s): 36800-111-01, 36800-111-06, 36800-111-25
  • Packager: TOP CARE (Topco Associates LLC)
  • 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 05/13

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

  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg

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  • Purpose

    Stool softener

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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 stool softener 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 controlled room temperature 15°-30°C (59°-86°F)
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  • Inactive ingredients

    D&C Red #33, edible ink, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, and titanium dioxide

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  • Questions or comments?

    1-888-423-0139

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  • Principal Display Panel

    SAFE, GENTLE & RELIABLE

    Stool Softener

    Docusate Sodium, 100 mg

    Relieves Constipation

    COMPARE TO COLACE® active ingreident*

    SOFTGELS 100 mg EACH

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

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

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL  60007

    topcare@topco.com

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

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  • Package Label

    TopCare

    Docusate Sodium 100 mg

     

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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:36800-111
    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
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    GELATIN  
    GLYCERIN  
    POLYETHYLENE GLYCOLS  
    PROPYLENE GLYCOL  
    SORBITOL  
    D&C RED NO. 33  
    TITANIUM DIOXIDE  
    FD&C BLUE NO. 1  
    WATER  
    SORBITAN  
    Product Characteristics
    Color RED, WHITE Score no score
    Shape OVAL Size 13mm
    Flavor Imprint Code P10;51A
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:36800-111-06 1 in 1 BOX
    1 60 in 1 BOTTLE
    2 NDC:36800-111-01 100 in 1 BOTTLE
    3 NDC:36800-111-25 250 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 07/01/2010
    Labeler - TOP CARE (Topco Associates LLC) (006935977)
    Registrant - P and L Development of New York Corporation (800014821)
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