Label: DOCUSATE SODIUM capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2024

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  • Active ingredient (in each softgel)

    Docusate sodium 100 mg

  • Purpose

    Stool softener

  • Uses

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

    Do not use

    if you are currently taking mineral oil, unless directed by a doctor

    Ask a doctor before use if you have

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

    Stop use and ask a doctor if

    •
    you have rectal bleeding
    •
    you fail to have a bowel movement after use
    •
    you need to use a stool softener 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

    •
    doses may be taken as a single daily dose or in divided doses

    adults and children 12 years and over                        

    take 1 to 3 softgels daily

    children 2 to under 12 years of age

    take 1 softgel daily

    children under 2 years

    ask a doctor
  • Other information

    •
    each capsule contains sodium 6 mg
    •
    store at room temperature 15o-30oC (59o-86oF)
    •
    Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing
  • Inactive ingredients: D&C red #33, Edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special

  • Questions?

    Adverse drug event call (800) 687-0176

  • Principal Display Panel

    Relabeled By:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    63187-476-00
  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-476(NDC:66424-030)
    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
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Colorred (Two toned- white and clear red) Scoreno score
    ShapeOVALSize5mm
    FlavorImprint Code 51A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-476-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    2NDC:63187-476-6060 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    3NDC:63187-476-9090 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    4NDC:63187-476-00100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00709/15/2010
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-476) , RELABEL(63187-476)
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