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 December 7, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg 

  • Purpose

    Stool Softner 

  • Uses

    • relieves occasional constipation (irregularity)
    • this product generally produces a bowel movement within 12 to 72 hours
  • WARNINGS

    Warnings

  • Do not use

    • if you are presently taking mineral oil, unless told to do so by a doctor
  • Ask a doctor before use if you have

    • stomach pain
    •  nausea
    • vomittiong
    • a sudden change in bowel habits that lasts more than 2 weeks
  • Stop use and ask a doctor if

    • you have rectal bleeding ot no bowel movement after use of a laxative. These could be signs of a serious condition.
    • yo need to use a stool softener laxative for more than 1 week
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222

  • Directions

    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 1-3 softgels daily.

    Children 2 to under 12 years of age :  take 1 softgel daily.

    Children under 2 years of age: ask a doctor

  • Other information

    • Store at 25°C  (77°F), excursions permitted between 15°-30°C (59°-86°F)
    • Keep tightly closed.
  • Inactive ingredients

    gelatin, glycerin, polyethylene glycol-400, povidone, propylene glycol, purified water, sorbitol solution, titanium dioxide.

  • Questions or comments?

    1-888-309-9030

  • PRINCIPAL DISPLAY PANEL

    DGTM Health

    Compare to the active ingredient of Colace®*

    STOOL SOFTENER CLEAR

    DOCUSATE SODIUM 100 mg

    Relieves constipation

    Gentle Relief

    Stimulant-Free
    Dye-Free

    100 Softgels

    * This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace.

    image description

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-223
    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
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorwhite (Transparent Softgels appear slightly Yellow) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code S50
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-223-101 in 1 CARTON05/21/2019
    1100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/21/2019
    Labeler - Dolgencorp, Inc. (068331990)
    Registrant - Spirit Pharmaceuticals LLC (179621011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PVT LTD677385498manufacture(55910-223)