Label: DOCUSATE SODIUM - docusate sodium capsule, liquid filled

  • NDC Code(s): 59105-007-50
  • Packager: J.P. BUSINESS ENTERPRISE
  • 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 November 17, 2014

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each softgel)

    Docusate sodium 100 mg

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  • Purpose

    Stool softener

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  • Uses

    • for prevention of dry, hard stools
    • for relief of occasional constipation

    This product generally produces a bowel movement within 12 to 72 hours.

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  • Warnings

    Do not use

    • if you are currently taking mineral oil, unless directed by a doctor
    • when abdominal pain, nausea, or vomiting are present
    • for longer than 1 week, unless directed by a doctor

    Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

    Stop use and ask a doctor if

    • you have rectal bleeding
    • you fail to have a bowel movement after use

    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.

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  • Directions

    • take with a glass of water
    adults and children 12 years of age and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
    children 2 to under 12 years of age take 1 softgel daily
    children under 2 years of age consult a physician
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  • Other information

    • each softgel contains: sodium 6 mg
    • store at controlled room temperature 15°-30°C (59°-86°F)
    • do not use if imprinted safety seal under cap is broken or missing
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  • Inactive ingredients

    FD&C Red # 40, FD&C Yellow #6, gelatin, glycerine, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide (for printing)

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  • Questions or comments?

    Call toll free: 1-888-333-9792

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  • SPL UNCLASSIFIED SECTION

    Distributed By: J.P Business Enterprise
    Lake Grove, NY 11755

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  • PRINCIPAL DISPLAY PANEL - 50 Softgel Bottle Carton

    VALUMEDS

    Compare to the active ingredient in
    Dulcolax® Stool Softener

    STOOL SOFTENER
    DOCUSATE SODIUM 100 MG

    • GENTLE RELIEF
    • EFFECTIVE
    • STIMULANT FREE

    50 SOFTGELS

    Principal Display Panel - 50 Softgel Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM  
    docusate sodium capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59105-007
    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
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color RED Score no score
    Shape OVAL Size 10mm
    Flavor Imprint Code 125
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59105-007-50 1 in 1 CARTON
    1 50 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 12/01/2014
    Labeler - J.P. BUSINESS ENTERPRISE (078775890)
    Establishment
    Name Address ID/FEI Business Operations
    MEDGEL PVT LTD 677385498 MANUFACTURE(59105-007)
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