Label: DOCUSATE SODIUM capsule, liquid filled

  • NDC Code(s): 68210-0350-1
  • Packager: Spirit Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each gelcaps)

    Docusate Sodium 100 mg 

  • Purpose

    Stool Softner

  • Uses

    • for the prevention of the dry, hard stools
    • for relief of occassional constipation. This product generally produces a bowel movement within 12 to 72 hours
  • Do not use

    if you are currently taking mineral oil, unless directed to so 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 abd ask a doctor if you

    have rectal bleeding fail to have a bowel movement occur after use.

  • If pregnant or breast-feeding 

    ask a health professional before use

    Keep out of reach of children

    In case of accidental overdose, get medical help or contact a Poison Control Center 1(800)222-1222 immediately.

  • Stop use and ask a doctor if you

    have rectal bleeding fail to have bowel movement occur after use.

  • If pregnant or breast feeding 

    Ask a health professional before use 

  • Keep out of reach of children

    In case of accidental overdose, get medical help or contact a Poison Control Center 1-800-222-1222 immediately.

  • Directions

    • adult and children 12 years and over: take 1-3 gelcaps, preferably at bedtime
    • children 2 to under 12 years of age: take 1 gelcap at bedtime
    • children under 2 years of age: ask a doctor
  • Other information

    • Store at room temperature 15-30°C  (59-86°F) 
    • do not use if safety seal under cap is torn or missing
  • Inactive ingredients

    FD&C Red #33, FD&C Red#40, FD&C Yellow#6, gelatin,

    glycerin, polyethylene glycol 400, propylene glycol, purified

    water, shellac, sorbitol solution, titanium dioxide.

  • Questions or comments?

    1-888-333-9792

  • PRICNIPAL DISPLAY PANEL

    Compare to the active ingredient in

    Colace ® Gel Caps *

    STOOL

    SOFTENER

    DOCUSATE SODIUM 100 mg

    Gentle

    Effective

    Stimulant-Free Relief

    100 GELCAPS

    Docusate 100 mg 100ct

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0350
    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)  
    SHELLAC (UNII: 46N107B71O)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite, redScoreno score
    ShapeCAPSULESize12mm
    FlavorImprint Code 413
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0350-11 in 1 CARTON03/10/2020
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00703/10/2020
    Labeler - Spirit Pharmaceuticals LLC (179621011)