Label: DOCUSATE SODIUM capsule, liquid filled

  • NDC Code(s): 68210-4104-0, 68210-4104-1
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg 

  • Purpose

    Stool Softner

  • Uses

    • for temporary relief of occasional constipation and irregularity
    • this product generally produces a bowel movement within 12 to 72 hours
  • WARNINGS

    Warnings

  • Ask a doctor before use if you have

    • stomach pain, nausea or vomittiong
    • a sudden change in bowel habits that lasts more than 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 signs of a serious condition.
    • you need to use laxative for more than 1 week.
  • PREGNANCY OR BREAST FEEDING

    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.1(800)222-1222

  • Directions

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

    Adults and children 12 years and over

    1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses

    Children 2 to under 12 years of age

    1 softgel daily.

    Children under 2 years of age

    Ask a doctor

  • Other information

    • Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
    • Keep tightly closed
  • Inactive ingredients

    FD&C Red#40, FD&C Yellow#6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.

  • Questions or comments?

    1-888-333-9792

  • PDP

    Cabinet:
    Stool Softener
    Docusate Sodium 100mg

    75 Softgels

    image description

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-4104
    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
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code 125
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-4104-175 in 1 PACKAGE; Type 0: Not a Combination Product07/02/2020
    2NDC:68210-4104-0100 in 1 BOTTLE; Type 0: Not a Combination Product07/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00707/02/2020
    Labeler - Spirit Pharmaceuticals LLC (179621011)
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