Label: DOCUSATE SODIUM capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 22, 2025

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  • Active ingredient (in each capsule)

    Docusate Sodium 100mg

  • Purpose

    Stool Softener

  • 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.
  • 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 ifyou 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 breast-feeding,ask a health professional before use. 

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children over 12 years of age:take 1-2 capsules, preferably at bedtime
    • Children 6-12 years of age:take 1 capsule at bedtime
  • Other information

    • each capsule contains:sodium 5 mg
    • store at controlled room temperature 15° - 30°C (59° - 86°F)
  • Inactive ingredients

    FD&C red #40, gelatin, glycerin, polyethylene glycol, propyleneglycol and sorbitol special. May also contain: D&C yellow #10, FC&C yellow #6 and purified water.

  • HOW SUPPLIED

    Product: 63739-478

  • Docusate Sodium

    Label Image
  • PRINCIPAL DISPLAY PANEL

    mckessondsslabel.jpg

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63739-478(NDC:61301-8001)
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    Colorred (Reddish) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63739-478-0125 in 1 BOX, UNIT-DOSE11/09/201002/28/2016
    130 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:63739-478-1010 in 1 BOX, UNIT-DOSE11/09/201002/28/2016
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:63739-478-481000 in 1 BOTTLE; Type 0: Not a Combination Product09/19/201709/21/2017
    4NDC:63739-478-40100 in 1 BOTTLE; Type 0: Not a Combination Product09/19/201709/21/2017
    5NDC:63739-478-0230 in 1 BOX, UNIT-DOSE07/01/202112/24/2025
    510 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)11/09/201012/24/2025
    Labeler - McKesson Corporation (140529962)
    Registrant - McKesson Corporation dba SKY Packaging (140529962)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Packaging Resources Inc.960203917repack(63739-478)
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