EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]

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EXTRA STRENGTH STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STATE OF FLORIDA DOH CENTRAL PHARMACY]
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NDC 53808-0902-1
Set ID 9b68acea-9eb4-406a-8c0d-2cc7a9317d02
Category HUMAN OTC DRUG LABEL
Packager State of Florida DOH Central Pharmacy
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 currently 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

    These could be signs of a serious condition.

    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

    • adults and children 12 years of age and over: take1 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 between 15º-30ºC (59º-86ºF)
  • Inactive Ingredients

    edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special

  • Questions or comments?

    1-800-645-2158

    Distributed by: Rugby Laboratories
    31778 Enterprise Drive
    Livonia, MI 48150
    www.rugbylaboratories.com

    This Product was Repackaged By:

    State of Florida DOH Central Pharmacy
    104-2 Hamilton Park Drive
    Tallahassee, FL 32304
    USA

    And supplied by State of Florida DOH Central Pharmacy as follows:

    NDCStrengthQuantity/FormColorSource Prod. Code
    53808-0902-1250 MG30 Capsules in a Blister Packorange0536-3757
  • PACKAGE LABEL

    Label Image for 53808-0902
    250mg

    Label Image for 250mg
  • INGREDIENTS AND APPEARANCE
    EXTRA STRENGTH STOOL SOFTENER LAXATIVE 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53808-0902(NDC:0536-3757)
    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
    ShapeOVAL (OVAL) Size20mm
    FlavorImprint Code P20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53808-0902-130 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33401/01/2014
    Labeler - State of Florida DOH Central Pharmacy (829348114)
    Establishment
    NameAddressID/FEIBusiness Operations
    State of Florida DOH Central Pharmacy829348114repack(53808-0902)
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