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 January 20, 2020

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

View All Sections
  • ACTIVE INGREDIENT

    Docusate Sodium 100 mg

    Purpose

    Stool softener

  • INDICATIONS & USAGE

    for 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

    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

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health care professional before use.

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    adults and children over 12 years of age take 1 to 3 softgels preferably at bedtime
    children 6-12 years of age take 1 softgel at bedtime
    children under 6 years ask a doctor

  • OTHER SAFETY INFORMATION

    each softgel contains: sodium 6 mg
    store between 15º-30ºC (59º-86ºF)

  • INACTIVE INGREDIENT


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

  • QUESTIONS


    1-800-645-2158

  • KEEP OUT OF REACH OF CHILDREN

  • PURPOSE

  • PRINCIPAL DISPLAY PANEL

    459-60

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-459(NDC:0536-3756)
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    GELATIN (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colororange ((orange)) Scoreno score
    ShapeOVAL ((OVAL)) Size13mm
    FlavorImprint Code P51
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-459-6060 in 1 BOTTLE; Type 0: Not a Combination Product08/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/14/2019
    Labeler - Direct_Rx (079254320)
    Registrant - Direct_Rx (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    Direct_Rx079254320repack(61919-459)
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!