Home > Drugs A-Z > MAJOR DOK Docusate Sodium

MAJOR DOK Docusate Sodium (Major Pharmaceuticals)

Available Formats

Dosage Form Package Information Links
CAPSULE, LIQUID FILLED 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0904-7889-60) Label Information
CAPSULE, LIQUID FILLED 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0904-7889-80) Label Information
CAPSULE, LIQUID FILLED 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0904-7889-59) Label Information

Complete MAJOR DOK Docusate Sodium Information

  • Active Ingredient (in each softgel)

    Docusate Sodium 100mg

    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 currently taking mineral oil, unless directed by a doctor
    • when abdominal pain, nausea or vomiting are present
    • for longer 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 care 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: take 1 to 3 softgels preferably at bedtime
    • children 6- 12 years of age: take 1 softgel at bedtime

  • Other information

    • each softgel contains: sodium 6mg
    • store at controlled room temperature 15o - 30o C (59o- 86o F)
    • do not use if imprinted safety seal under cap is broken or missing.
    • *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace®

  • Inactive Ingredients

    edible ink, FDandC Red #40, FDandC Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.


  • Questions or comments?

    Adverse Drug Event Call: (800)-616-2471)


  • PRINCIPAL DISPLAY PANEL

    MAJOR® DOKâ„¢ 100 mg Docusate Sodium

    For use as a stool softener in treating & avoiding constipation

    *Compare to the active ingredient in COLACE®


  • Product Labeling

    Major DOK Stool Softener 100 mg 1000 count

    Docusate Sodium 100 mg 1000 count

     


  • INGREDIENTS AND APPEARANCE
    MAJOR DOK DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7889
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color ORANGE (ORANGE) Score no score
    Shape OVAL (OVAL) Size 13mm
    Flavor Imprint Code P51
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-7889-59 100 in 1 BOTTLE
    2 NDC:0904-7889-60 100 in 1 BOTTLE
    3 NDC:0904-7889-80 1000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part334 04/23/2010
    Labeler - Major Pharmaceuticals (191427277)