Label: DOCUSATE SODIUM capsule

  • 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 September 14, 2021

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

  • ACTIVE INGREDIENT

    Docusate Sodium 100 mg

  • PURPOSE

    Stool softener laxative

  • DOSAGE & ADMINISTRATION

    take only by mouth. Doses may be taken as a single daily dose or in divided doses.

    adults and children 12 years and over take 1 to 3 softgels daily.
    children 2 to under 12 years of age take 1 softgel daily
    children under 2 years ask a doctor

  • WHEN USING

    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 told to do so by a doctor.

    Ask a doctor before use if you have

    stomach pain
    nausea
    vomiting
    noticed a sudden change in bowel habits that last over 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 could be a signs of a serious condition.
    you need to use a 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • OTHER SAFETY INFORMATION

    each softgel contains: sodium 5 mg
    store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)

  • INDICATIONS & USAGE

    edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol

  • QUESTIONS

    Call 1-800-616-2471

  • KEEP OUT OF REACH OF CHILDREN

  • INACTIVE INGREDIENT

  • PRINCIPAL DISPLAY PANEL

    hi

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72189-236(NDC:0904-6998)
    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 (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColororangeScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code P51
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72189-236-3030 in 1 BOTTLE; Type 0: Not a Combination Product09/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33409/14/2021
    Labeler - Direct Rx (079254320)
    Registrant - Direct Rx (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    Direct Rx079254320repack(72189-236)