EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC]

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EXTRA STRENGTH STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC]
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NDC 68016-191-10
Set ID 0819023e-424d-43b2-a849-1c06e1f7246b
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium, LLC
Generic Name
Product Class
Product Number
Application Number PART334
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  • Active ingredient (in each softgel)

    Docusate Sodium 250 mg

    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 15 mg
    • 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 #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

  • Principal Display Panel

    Extra Strength

    STOOL SOFTENER

    Docusate Sodium

    Relieves Constipation

    DISTRIBUTED BY:

    CHAIN DRUG CONSORTIUM, LLC

    2300 NW CORPORATE BLVD., SUITE 115

    BOCA RATON, FL 33431

  • Product Label

    premier value docusate sodium 250 mg 100 count

    Docusate Sodium 250 mg

  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-191
    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
    ColorORANGEScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code P20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-191-10100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33407/08/2010
    Labeler - Chain Drug Consortium, LLC (101668460)
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