Label: DOK EXTRA STRENGTH STOOL SOFTENER- 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 September 13, 2013

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  • Active ingredient (in each softgel)

    Docusate Sodium 250mg

    Purpose

    Stool softener

  • Uses

    • for the prevention of dry, hard stools
    • for relief of occasional constipation.
    • this product generally produces a bowel movement within 12 to 72 hours.
  • Warnings - Do not use

    • if you are taking mineral oil, unless directed by a doctor
    • when abdominal pain, nausea, or vomiting are present
    • for more 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 breastfeeding

    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

    • adults and children over 12 years of age and over: take 1 softgel daily or as directed by a doctor
    • children under 12 years of age: take as directed by a doctor
  • Other information

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

    edible white ink, FD&C Red No# 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified wter, sorbitol special.

  • Questions or comments?

    Adverse Drug Event Call: (800) 616-2471

  • Product Labeling

    MAJOR DOK™

    Docusate Sodium 250 mg

    Extra Strength Stool Softener

    For use as a Stool Softener in treating & Avoiding Constipation

    Distributed by:

    Major Pharmaceuticals

    31778 Enterprise Drive

    Livonia, MI 48150, USA

    Repackaged By :
    Aidarex Pharmaceuticals LLC,
    Corona, CA 92880

  • PRINCIPAL DISPLAY PANEL

     IMAGE LABEL

  • INGREDIENTS AND APPEARANCE
    DOK EXTRA STRENGTH STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0440-1466(NDC:0904-7891)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 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 GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorORANGE (orange) Scoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code P20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0440-1466-3030 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33408/27/2002
    Labeler - Liberty Pharmaceuticals, Inc. (012568840)
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