Label: FLEET- docusate sodium capsule, liquid filled

  • NDC Code(s): 0132-0402-25
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 27, 2024

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

View All Sections
  • SPL UNCLASSIFIED SECTION

  • Active ingredient (in each softgel)

    Docusate sodium 100 mg

  • Purpose

    Stool softener

  • Uses

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

    Do not use

    • if you are presently taking mineral oil, unless directed by a doctor

    Ask a doctor before use if you have

    • abdominal pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that lasts over a period of 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 symptoms may indicate 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 accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
    Adults and children 12 years and overtake 1-3 softgels daily
    Children 2 to under 12 years of agetake 1 softgel daily
    Children under 2 yearsask a doctor
  • Other information

    • each softgel contains: sodium 5 mg
    • VERY LOW SODIUM
    • store at 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F)
  • Inactive ingredients

    black edible ink, citric acid, D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol solution, water

  • Questions?

    Call 1-866-255-6960

  • Principal Display Panel

    Fleet

    Docusate sodium 100 mg Stool Softener

    Oral Laxative

    25 softgels

    Principal Display Panel Fleet Docusate sodium 100 mg Stool Softener Oral Laxative 25 softgels

  • INGREDIENTS AND APPEARANCE
    FLEET 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-0402
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Colorred, whiteScoreno score
    ShapeOVALSize7mm
    FlavorImprint Code PC18
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-0402-2525 in 1 BOTTLE; Type 0: Not a Combination Product06/21/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00706/21/2024
    Labeler - C.B. Fleet Company, Inc. (003119054)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!