Label: DOCUSATE SODIUM tablet

  • Category: HUMAN OTC DRUG LABEL

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 4, 2015

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  • OTC - ACTIVE INGREDIENT SECTION

    Docusate sodium 100 mg

  • OTC - PURPOSE SECTION

    Stool softener

  • INDICATIONS & USAGE SECTION


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

  • OTC - DO NOT USE SECTION

    Do not use if you are presently taking mineral oil, unless told to do so by a doctor

  • OTC - ASK DOCTOR SECTION


    stomach pain  
    nausea  
    vomiting  
    noticed a sudden change in bowel habits that lasts over 2 weeks

  • OTC - STOP USE SECTION


    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

  • OTC - PREGNANCY OR BREAST FEEDING SECTION

    If pregnant or breast-feeding, ask a health professional before use.

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION SECTION

    doses may be taken as a single daily dose or in divided doses

  • OTHER SAFETY INFORMATION

    each softgel contains: sodium 5 mg VERY LOW SODIUM  
    store at 15°-30°C (59°-86°F)  
    keep tightly closed

    You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

  • INACTIVE INGREDIENT SECTION

    FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbital special

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    QUALITEST PHARMACEUTICALS
    HUNTSVILLE, AL 35811

    R0 07/2011
    015021CPR

  • WARNINGS SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-888(NDC:0603-0150)
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorred (Reddish) Scoreno score
    ShapecapsuleSize12mm
    FlavorImprint Code SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-888-71100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:61919-888-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
    3NDC:61919-888-6060 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33401/01/2015
    Labeler - Direct Rx (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    Direct Rx079254320relabel(61919-888) , repack(61919-888)
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