Label: DOCUSATE SODIUM- docusate sodium capsule

  • NDC Code(s): 16103-384-08, 16103-384-11
  • Packager: Pharbest Pharmaceuticals, Inc.
  • 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 July 6, 2010

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

  • Active ingredient (in each softgel)

    Docusate sodium 100 mg


  • Purpose

    Stool softener

  • Uses

    • prevents/relieves dry hard stool
    • results usually occurs 1 to 3 days after the first dose
  • Warnings


    Do not use

    • when abdominal pain, nausea, or vomiting are present
    • for more than one week unless directed by a doctor

    Ask a doctor before use if you

    • are taking mineral oil
    • have noticed a sudden change in bowel habits that last over 2 weeks

    Stop use and ask a doctor if

    • you have no bowel movement after 3 days
    • you have rectal bleeding
    These could be signs of a serious condition

    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 right away.

  • Directions

    • do not exceed recommended dose
    adults and children over 12 years                        
    take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
    children 6 to 12 years
    take 1 softgel daily
    children under 6 years
    consult a doctor
  • Other information

    • Tamper Evident: Do not use if safety seal under cap is broken or missing
    • store at room temperature 15o to 30oC (59o to 86oF)
    • protect from moisture
  • Inactive ingredients: D&C yellow #10, FD&C red #40, gelatin, glycerin, ink white, polyethylene glycol, sorbitol, propylene glycol.


  • Questions?

    Adverse drug event call: (866) 562-2756

  • Principal Display Panel

    *Compare to the active ingredient of Colace®

    Docusate Sodium

    Stool Softener

    1000 SOFTGELS

    100 mg each

    Image of Docusate label

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-384
    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
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    Gelatin (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyethylene Glycol (UNII: 3WJQ0SDW1A)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    Colorred (Two-toned- white and clear red) Scoreno score
    ShapeOVALSize5mm
    FlavorImprint Code 51A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16103-384-08100 in 1 BOTTLE
    2NDC:16103-384-111000 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/22/2007
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc557054835repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Accucaps Industries Ltd.248441727manufacture