Label: STOOL SOFTENER- 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 May 11, 2013

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  • Active Ingredient

    (in each softgel)

    Docusate Sodium 100 mg

  • Purpose

    Stool softener laxative

  • Uses

    • for temporary relief of occasional constipation and irregularity
    • this product generally produces bowel movement in 12 to 72 hours
  • Warnings

    Ask a doctor before use if you have:

    • stomach pain, nausea or vomiting
    • a sudden change in bowel habits that lasts more than 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 no bowel movement after using this product. This could be signs of a serious condition.
    • you need to use 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 with glass of water

    adults and children 12 years and over:

    • 1 to 3 liquid gels daily. This dose may be taken as single daily dose or in divided doses.

      Children under 12 years of age:

    • 1 liquid gel daily

    Children under 2 years of age

    Ask a doctor

  • Other Information

    • store at 15-30 °C (59-86 °F)
    • protect from excessive humidity
    • do not use this product if the safety seal under the cap is torn or missing
  • Inactive Ingredients

    FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitol special, titanium dioxide

  • Questions or Comments

    Call 1-855-314-1850

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    5d5cb3d5-figure-01

    5d5cb3d5-figure-02

    NDC: 076168-069-05 – 25 COUNT

  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-069
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize5mm
    FlavorImprint Code V100
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76168-069-0525 in 1 BOTTLE
    11 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/01/2013
    Labeler - Velocity Pharma (962198409)
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