Label: DOCUSATE SODIUM- docusate sodium capsule, liquid filled 

  • Label RSS
  • 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 02/13

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

  • Active Ingredient (in each softgel)

    Docusate Sodium 100mg

    Purpose

    Stool softener

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  • Uses

    • for the prevention of dry, hard stools
    • for relief of occasional constipation.

    This product generally produces a bowel movement within 12 to 72 hours.

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  • Warnings - Do not use

    • if you are currently taking mineral oil, unless directed by a doctor
    • when abdominal pain, nausea or vomiting are present
    • for longer than 1 week, unless directed by a doctor

    Ask a doctor before use if

    you notice a sudden change in bowel habits that persists over a period of 2 weeks

    Stop use and ask a doctor if

    • you have rectal bleeding
    • you fail to have a bowel movement after use

    If pregnant or breastfeeding

    ask a health care 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

    • adults and children over 12 years of age: take 1 to 3 softgels preferably at bedtime
    • children 6- 12 years of age: take 1 softgel at bedtime
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  • Other information

    • each softgel contains: sodium 6mg
    • store at controlled room temperature 15o - 30o C (59o- 86o F)
    • *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace®
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  • Inactive Ingredients

    edible ink, FDandC Red #40, FDandC Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

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  • Questions or comments?

    Adverse Drug Event Call: (800)-616-2471)

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  • PRINCIPAL DISPLAY PANEL

    Distributed by : Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.

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  • Principal Display Panel

    Principal Display Panel-Docusate Sodium 100mg

     

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  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0615-0585(NDC:0904-7889)
    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  
    WATER  
    SORBITOL  
    Product Characteristics
    Color ORANGE (ORANGE) Score no score
    Shape OVAL (OVAL) Size 13mm
    Flavor Imprint Code P51
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0615-0585-05 15 in 1 BLISTER PACK
    2 NDC:0615-0585-31 31 in 1 BLISTER PACK
    3 NDC:0615-0585-39 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 04/23/2010
    Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
    Establishment
    Name Address ID/FEI Business Operations
    NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL(0615-0585), REPACK(0615-0585)
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