Label: DOCUSATE SODIUM capsule

  • NDC Code(s): 73147-8273-1
  • Packager: Cellchem Pharmaceutical Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • Active Ingredient (in each capsule)                         Purpose

    Docusate sodium 100 mg................................................Laxative, stool softener

  • PURPOSE

    Stool Softener

  • Uses

    • Relief of occasional constipation 
    • softens the stools
  • Warnings


    Do not use

    • if you have
      • abdominal pain
      • nausea
      • fever
      • vomiting
    • with other medicines or if you are presently taking mineral oil
    • if you are on a low salt diet
    • longer than 7 days

    When using this product

    • frequent or prolonged use may result in dependence on laxatives
    • it may take up to 3 days for you to have a bowel movement

    Stop use and ask a doctor if

    • rectal bleeding occurs
    • symptoms persist, last for more than 7 days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, call a poison control centre or get medical help right away, even if you do not notice any signs or symptoms. 

  • Directions

    • Adults and children 12 years and over: 
    • Take 1 - 2 capsules daily or as directed by physician 
    • Do not take more than 4 capsules per day.
    • Drink lots of fluids (one full glass or more)
  • Other information

    • Questions ?

    1(844) 481-8884

  • Inactive ingredients

    Polyethylene glycol 400, propylene glycol, gelatin, glycerin, sodium methyl paraben, sodium propyl paraben, sorbitol sorbitan solution, purified water, FD&C Red No. 40, FD&C Yellow No. 6.

  • SPL UNCLASSIFIED SECTION

    Manufactured for :
    CellChem Pharmaceuticals Inc.
    Ottawa, ON, Canada K2E 7V7

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73147-8273
    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)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred (Dark Red) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73147-8273-1100 in 1 BOTTLE; Type 0: Not a Combination Product10/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00710/10/2023
    Labeler - Cellchem Pharmaceutical Inc (111518618)
    Establishment
    NameAddressID/FEIBusiness Operations
    Softgel Healthcare Private Limited675584180manufacture(73147-8273)
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