DOK (DOCUSATE SODIUM) CAPSULE [QUALITY CARE PRODUCTS, LLC]

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DOK (DOCUSATE SODIUM) CAPSULE [QUALITY CARE PRODUCTS, LLC]
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NDC 55700-719-30
Set ID 6042839a-843c-4e91-aeb6-fd883b85a345
Category HUMAN OTC DRUG LABEL
Packager Quality Care Products, LLC
Generic Name
Product Class
Product Number
Application Number PART334
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  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg

  • Purpose

    Stool softener laxative

  • 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 last 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 a signs of a serious condition.
    • you need to use a 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.

  • Directions

    • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
    adults and children 12 years and overtake 1 to 3 softgels daily.
    children 2 to under 12 years of agetake 1 softgel daily
    children under 2 years ask a doctor
  • Other information

    • each softgel contains: sodium 6 mg
    • store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)
  • Inactive ingredients

    edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water sorbitan, sorbitol

    *contains one or more of these ingredients

  • Questions or comments?

     Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    DOK 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55700-719(NDC:0904-6457)
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    SORBITAN (UNII: 6O92ICV9RU)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code P51;S77;SCU1;D2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55700-719-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/18/2019
    2NDC:55700-719-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33401/18/2019
    Labeler - Quality Care Products, LLC (831276758)
    Establishment
    NameAddressID/FEIBusiness Operations
    Quality Care Products, LLC831276758repack(55700-719)
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