Label: STOOL SOFTNER- docusate sodium capsule, liquid filled

  • 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 March 1, 2016

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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 15o-30oC (59o-86oF).

    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) 687-0176 Mon- Fri 8 AM to 4 PM

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

  • PRINCIPAL DISPLAY PANEL

    NDC 66424-399-10

    *Compare to the active ingredient in Colace®

    STOOL SOFTENER

    ORIGINAL

    DOCUSATE SODIUM 100mg

    SDA LABORATORIES

    1000 Softgel Capsules

    SDA Docusate Sodium 100 mg Capsule 1000 CT Label

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTNER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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 GLYCOLS (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:66424-399-01100 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:66424-399-101000 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/01/2016
    Labeler - SDA Laboratories, Inc. (948067889)
    Registrant - Pharbest Pharmaceuticals, Inc. (557054835)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharbest Pharmaceuticals, Inc557054835repack(66424-399) , relabel(66424-399)
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