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Pill Identifier Information of DOSS Sodium 250 MG Oral Capsule

Drug Information

DOSS Sodium 250 MG Oral Capsule

Imprint: P20
Shape: C48336
Color: C48331
Ingredients: Docusate
Size: 20.00
Score: 1
Rxtty: SY
Author: H.J. Harkins Company, Inc.
Inactive Ingredients: FD&C RED NO. 40 / FD&C YELLOW NO. 6 / GELATIN / GLYCERIN / POLYETHYLENE GLYCOLS / PROPYLENE GLYCOL / WATER / SORBITOL>

Complete Information

  • 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 DOKâ„¢

    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

    Repacked by:

    H.J. Harkins Company, Inc.

    Grover Beach, CA 93433

  • PRINCIPAL DISPLAY PANEL

     Major DOK Docusate Sodium 250 mg

    Docusate Sodium 250 mg

  • INGREDIENTS AND APPEARANCE
    DOK EXTRA STRENGTH STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76519-1003(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:76519-1003-660 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33408/27/2002
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Registrant - H.J. Harkins Company, Inc. (147681894)
    Establishment
    NameAddressID/FEIBusiness Operations
    H.J. Harkins Company, Inc.147681894repack(76519-1003) , relabel(76519-1003)