Label: DOCUSATE SODIUM capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 13, 2023

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  • Active ingredient (in each liquid-filled capsule)

    Docusate sodium 100 mg

  • Purpose

    Stool softener laxative

  • Uses

    •
    relieves occasional constipation (irregularity)
    •
    generally produces bowel movement in 12 to 72 hours
  • Warnings

    Ask a doctor before use if you have

    •
    stomach pain
    •
    nausea
    •
    vomiting
    •
    noticed a sudden change in bowel habits that lasts over 2 weeks

    Ask a doctor or pharmacist before use if you are

    presently taking mineral oil.

    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 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

    •
    do not take more than directed
    •
    take with a glass of water
    •
    take only by mouth. Doses may be taken as a single daily dose or in divided doses.

    adults and children 12
    years and over

    take 1 to 3 capsules daily

    children 2 to under 12
    years

    take 1 capsule daily  

    children under 2 years

    ask a doctor
  • Other information

    •
    each capsule contains: sodium 8 mg
    Very Low Sodium
    •
    store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    •
    protect from light, heat and moisture
    •
    TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    •
    see end flap for expiration date and lot number
  • Inactive ingredients

    FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, white ink

  • Questions or comments?

     (800) 616-2471

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L57365330921

  • Principal Display Panel

    Docusate Sodium

    Unit Dose

    10 Softgels

    bag label
  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-2340(NDC:0904-7115)
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 752
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-2340-010 in 1 BAG04/16/2021
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/16/2021
    Labeler - Cardinal Health 107, LLC (118546603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aphena Pharma Solutions - Tennessee, LLC118348161REPACK(55154-2340)
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