Label: FLEET- docusate sodium capsule, gelatin coated 

  • NDC Code(s): 0132-0751-60
  • Packager: C.B. Fleet Company, Inc.
  • 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 07/14

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

  • Active Ingredient

    (in each softgel)

    Docusate Sodium 100 mg..............Stool Softener

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  • Uses

    • for the prevention of dry, hard stools
    • for relief of occasional constipation
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  • If pregnant or breast-feeding

    Ask a health care professional before use.

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  • 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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  • 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 one week, unless directed by a doctor
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  • Ask a doctor before use if

    • you notice a sudden change in bowel habits that persists over a period of 2 weeks
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  • Stop use and ask a doctor if

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

    These symptoms may indicate a serious condition.

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  • Directions

    Single Daily Dosage

    adults and children 12 years and over
    1 - 3 softgels
    children 2 to under 12 years
    1 softgel
    children under 2 years
    ask a doctor
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  • Other Information

    • each softgel contains: sodium 5 mg
    • this product generally produces a bowel movement within 12 to 72 hours
    • mouth of bottle sealed for your safety. If foil impirinted "SEALED FOR YOUR PROTECTION" is broken or missing, do not use
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  • Inactive Ingredients

    edible white ink, FDandC red 40, FDandC yellow 6, gelatin, glycerin, mannitol, polyethylene glycol, polysorbate, propylene glycol, purified water and sorbitol

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  • Questions?

    1-866-255-6960 or www.fleetlabs.com

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  • INGREDIENTS AND APPEARANCE
    FLEET 
    docusate sodium capsule, gelatin coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0132-0751
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg  in 60 
    Inactive Ingredients
    Ingredient Name Strength
    FD&C YELLOW NO. 6  
    FD&C RED NO. 40  
    GELATIN  
    GLYCERIN  
    MANNITOL  
    POLYETHYLENE GLYCOL 400  
    PROPYLENE GLYCOL  
    WATER  
    SORBITOL  
    POLYSORBATE 20  
    Product Characteristics
    Color red (Clear, Bright Red) Score no score
    Shape OVAL Size 5mm
    Flavor Imprint Code P51
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0132-0751-60 60 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 06/30/2002
    Labeler - C.B. Fleet Company, Inc. (003119054)
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