Label: DOCUSATE SODIUM capsule, liquid filled

  • 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 March 2, 2015

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  • Active ingredient (in each softgel)

    Docusate sodium 100 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 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).

  • 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 agetake 1 softgel daily
    children under 2 yearsask a doctor

  • Other information

    • Tamper Evident: do not use if safety seal under cap is broken or missing
    • each capsule contains: sodium 6 mg
    • VERY LOW SODIUM
    • store at 25°C (77°F); excursions permitted between 15 o-30 oC (59 o-86 oF).

    Keep tightly closed.

    This Package for Households Without Young Children 

  • 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 

  • Questions?

    Adverse drug event call: (800) 722-0772 Mon- Fri 8 AM to 5 PM

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

  • Package Label.Principal Display

    51655-342-20

    NDC: 51655-342-20

    MFG: 66424-399-10

    Docusate Sodium 100 MG

    20 Capsules

    OTC

    Lot#:

    Exp. Date:

    Each tablet contains 100 mg docusate sodium and 6 mg of sodium

    Dosage: See prescriber's instructions

    Store between 59-86 degrees F. Protect from light & moisture.

    Keep out of the reach of children.

    Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

    Dist. by: SDA Laboratories, Inc Greenwich, CT 06830 Lot#:

    Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

    51655-342-52

    NDC: 51655-342-52

    MFG: 66424-399-10

    Docusate Sodium 100 MG

    30 Capsules

    OTC

    Lot#:

    Exp. Date:

    Each tablet contains 100 mg docusate sodium and 6 mg of sodium

    Dosage: See prescriber's instructions

    Store between 59-86 degrees F. Protect from light & moisture.

    Keep out of the reach of children.

    Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

    Dist. by: SDA Laboratories, Inc Greenwich, CT 06830 Lot#:

    Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

    51655-342-25

    NDC: 51655-342-25

    MFG: 66424-030-10

    Docusate Sodium 100 MG

    60 Capsules

    OTC

    Lot#:

    Exp. Date:

    Each tablet contains 100 mg docusate sodium and 6 mg of sodium

    Dosage: See prescriber's instructions

    Store between 59-86 degrees F. Protect from light & moisture.

    Keep out of the reach of children.

    Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

    Dist. by: SDA Laboratories, Inc Greenwich, CT 06830 Lot#:

    Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51655-342(NDC:66424-399)
    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
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorred (Two toned- white and clear red) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code SCU2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-342-2020 in 1 BOTTLE; Type 0: Not a Combination Product08/14/2017
    2NDC:51655-342-5230 in 1 BOTTLE; Type 0: Not a Combination Product01/25/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/14/2017
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-342)
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