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

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  • Purpose

    Stool softener

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  • Uses

    • relieves occasional constipation (irregularity) 
    • generally produces bowel movement in 12 to 72 hours
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  • 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)

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  • 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 age take 1 softgel daily
    children under 2 years ask a doctor

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  • 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.

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  • 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 

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  • Questions?

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

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  • 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

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  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium 100mg capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:16103-399
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color red (Two-toned- white and clear red) Score no score
    Shape OVAL Size 12mm
    Flavor Imprint Code SCU2
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16103-399-08 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2016
    2 NDC:16103-399-11 1000 in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 03/01/2016
    Labeler - Pharbest Pharmaceuticals, Inc. (557054835)
    Registrant - Pharbest Pharmaceuticals, Inc (557054835)
    Establishment
    Name Address ID/FEI Business Operations
    Pharbest Pharmaceuticals, Inc 557054835 repack(16103-399) , relabel(16103-399)
    Establishment
    Name Address ID/FEI Business Operations
    SWISSCAPS Romania srl 565466997 manufacture(16103-399)
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