Label: DOCUSATE SODIUM capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 August 23, 2021

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

  • 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 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 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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    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)  
    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-DOSE07/01/2021
    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 not finalpart33411/09/2010
    Labeler - McKesson Corporation (140529962)
    Establishment
    NameAddressID/FEIBusiness Operations
    Contract Packaging Resources Inc.960203917repack(63739-478)