Label: DOCUSATE SODIUM- docusate sodium 100mg capsule

  • NDC Code(s): 16103-399-08, 16103-399-11
  • 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 March 1, 2016

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

  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg

  • Purpose

    Stool softener

  • Uses

    • 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 lasts over 2 weeks

    Stop use and ask a doctor if

    • you have rectal bleeding or fail to have bowel movement after use of a laxative. These could be signs of a serious condition.
    • you need to use a stool softener 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 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                 take 1-3 softgels daily
    children 2 to under 12 years of agetake 1 softgel daily
    children under 2 yearsask a doctor

  • Other information

    • Tamper Evident: Do not use if safety seal under cap is broken or missing
    • each softgel contains: sodium 6 mg
    • VERY LOW SODIUM
    • store at 25oC (77oF); excursions permitted between 15o-30oC (59o-86oF).

    keep tightly closed.

  • Inactive ingredients

    D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide 

  • Questions?

    Adverse drug event call: (866) 562-2756 Mon-Fri 8 AM to 4 PM

  • PRINCIPAL DISPLAY PANEL

    NDC 16103-0399-11

    PHARBEST

    *Compare to the active ingredient of Colace®

    Docusate

    Sodium

    Stool Softener

    1000 SOFTGELS

    100 mg each

    Pharbest Docusate Sodium 100 mg Softgel Product Label

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium 100mg capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-399
    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 RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorred (Two-toned- white and clear red) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code SCU2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16103-399-08100 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2016
    2NDC:16103-399-111000 in 1 BOTTLE; Type 0: Not a Combination Product03/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/01/2016
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Registrant - Pharbest Pharmaceuticals, Inc (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc557054835repack(16103-399) , relabel(16103-399)
    Establishment
    NameAddressID/FEIBusiness Operations
    SWISSCAPS Romania srl565466997manufacture(16103-399)