Label: DOCUSATE SODIUM - docusate sodium capsule

  • 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 February 2, 2018

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

  • Active ingredient

    (in each Capsule)

    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
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  • Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel habits that lasts over 2 weeks
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  • Stop use and ask a doctor if

    • you have rectal bleeding or fail to have a 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
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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • Keep out of reach of children.

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

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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 capsules daily
    children 2 to under 12 years of age
    take 1 capsule daily
    children under 2 years
    ask a doctor
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  • Other information

    • each capsule contains: sodium 5 mg Very Low Sodium
    • store at 25°C (77°F); excursions permitted between 15-30ºC (59-86ºF). Keep tightly closed.
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  • Inactive ingredients

    D&C Red No.33, gelatin, glycerin, Neelicert FD&C Red No.40, Neelicert FD&C Yellow No.6, noncrystallizing sorbitol solution, polyethylene glycol, propylene glycol, purified water, shellac glaze, titanium dioxide.

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  • Questions or Comments?

    Call 1-855-274-4122

    (Monday - Friday 8:30 AM to 5:00 PM EST)


    *This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®.


    Distributed by:
    Aurohealth LLC.
    2572 Brunswick Pike
    Lawrenceville, NJ 08648

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  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (600 Capsules Container Label)

    AUROHEALTH

    NDC 58602-767-64


    Compare to Colace®

    active ingredient*

    Stool Softener

    Docusate sodium 100 mg

    Regular Strength

    • Gentle, Dependable
    • Stimulant-free

    600 Capsules
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (600 Capsules Container Label)

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  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-767
    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)  
    GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SHELLAC (UNII: 46N107B71O)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color RED Score no score
    Shape OVAL Size 13mm
    Flavor Imprint Code Q04
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58602-767-64 600 in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 02/08/2018
    Labeler - Aurohealth LLC (078728447)
    Establishment
    Name Address ID/FEI Business Operations
    Aurohealth LLC 078728447 MANUFACTURE(58602-767)
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