Label: STOOL SOFTENER EXTRA STRENGTH- 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 19, 2020

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  • Active ingredient (in each softgel)

    Docusate sodium 250 mg

  • Purpose

    Stool softener laxative

  • 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 presently taking mineral oil, unless directed by a doctor.

    Ask a doctor before use if you have

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

    • adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
    • children under 12 years of age: ask a doctor
  • Other information

    • each softgel contains:sodium 15 mg
    • store between 20-25ºC (68-77ºF); excursions permitted between 15-30ºC (59-86ºF)
  • Inactive ingredients​

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

    *may contain this ingredient

  • Questions or comments?

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

  • HOW SUPPLIED

    Product: 71335-0632

    NDC: 71335-0632-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

    NDC: 71335-0632-2 60 CAPSULE, LIQUID FILLED in a BOTTLE

    NDC: 71335-0632-3 100 CAPSULE, LIQUID FILLED in a BOTTLE

    NDC: 71335-0632-4 7 CAPSULE, LIQUID FILLED in a BOTTLE

  • Docusate Sodium 250mg Capsule

    Label Image
  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER  EXTRA STRENGTH
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0632(NDC:0536-1064)
    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, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code P20;SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71335-0632-130 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
    2NDC:71335-0632-47 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
    3NDC:71335-0632-260 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
    4NDC:71335-0632-3100 in 1 BOTTLE; Type 0: Not a Combination Product01/03/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33401/31/2015
    Labeler - Bryant Ranch Prepack (171714327)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bryant Ranch Prepack171714327REPACK(71335-0632) , RELABEL(71335-0632)
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