Label: DOCUSATE SODIUM capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 20, 2009

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  • Drug Facts

  • Active ingredient(in each capsule)

    Docusate sodium 50 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 a bowel movement after use of a laxative. These could be signs of a serious condition.
    • you need to use a 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.

  • Directions

    • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
    adults and children 12 years and overtake 1-6 capsules daily
    children 2 to under 12 years of agetake 1-3 capsules daily
    children under 2 yearsask a doctor
  • Inactive ingredients

    D&C Red No. 33, FD&C Red No. 40, gelatin, glycerin, PEG 400, propylene glycol, sorbitol

  • QUESTIONS

    Questions? 1-888-726-7535
    (8am-5pm, EST, Mon.-Fri.).

  • PRINCIPAL DISPLAY PANEL

    Docusate Sodium capsules USP 50mg
    Each Softgel Contains:
    (Docusate Sodium USP 50mg)

    LOT NO :

    DRUM NO :

    MFG DATE :

    QUANTITY :

    NDC NO : 68210-0402-

    EXP DATE :

    WARNING:
    KEEP OUT OF REACH OF CHILDREN

    STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
    PROTECT FROM LIGHT, MOISTURE AND FREEZING

    THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
    CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
    THE F.D & C. ACT AND REGULATIONS THEREUNDER.

    MANUFACTURED BY:
    SOFTGEL HEALTHCARE PVT LIMITED
    INDIA
    LABELLER CODE : 35916
    LIC NO. : TN/DRUGS/00002124

    MANUFACTURED FOR:
    SPIRIT PHARMACEUTICALS LLC
    225 LINCOLN HWY, STE 205
    FAIRLESS HILLS, PA 19030
    PH.# 215 943 4000
    FAX.# 215 943 4039

    CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

    • 1 – 10
    • 2 – 30
    • 3 – 100
    • 4 – 1000
    • 5 – 16000
    Principal Display Panel
  • SPL UNCLASSIFIED SECTION

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0402
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code DO4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-0402-11 in 1 BOX
    110 in 1 BAG
    2NDC:68210-0402-21 in 1 BOX
    230 in 1 BAG
    3NDC:68210-0402-31 in 1 BOX
    3100 in 1 BAG
    4NDC:68210-0402-41 in 1 BOX
    41000 in 1 BAG
    5NDC:68210-0402-51 in 1 BOX
    516000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart310.54510/01/2009
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    SOFTGEL HEALTHCARE PVT LTD675584180MANUFACTURE
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