Label: DOCUSATE SODIUM- docusate sodium capsule 

  • 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 02/14

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

  • Active ingredient (in each softgel)

    Docusate Sodium 250mg

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  • 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 more 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 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 and over: take 1 softgel daily or as directed by a doctor

    • children under 12 years of age: take as directed by a doctor

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  • Other information

    • each softgel contains: sodium 15mg

    • store at controlled room temperature 15° - 30° C (59° - 86° F)

    • do not use if imprinted safety seal under cap is broken or missing

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  • Inactive ingredients

    edible white ink, FD&C Red # 40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.

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  • Questions?

    Adverse Drug Event Call: (800) 616-2471

    Distributed by:

    Major Pharmaceuticals

    31778 Enterprise Drive

    Livonia, MI 48150, USA

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  • Principal Display Panel

    Docusate Sodium Softgel Caps 250mg

    Principal Display Panel-Docusate Sodium Softgel Capsule 250mg
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  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0615-0586(NDC:0904-7891)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    GELATIN  
    GLYCERIN  
    PROPYLENE GLYCOL  
    WATER  
    SORBITOL  
    POLYETHYLENE GLYCOLS  
    Product Characteristics
    Color RED (Orange) Score no score
    Shape CAPSULE Size 21mm
    Flavor Imprint Code P20
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0615-0586-39 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 07/01/2010
    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(0615-0586), REPACK(0615-0586)
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