Label: DOCUSATE SODIUM capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 7, 2023

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  • 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 100
    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 DrugM00705/21/2019
    Labeler - Dolgencorp, Inc. (068331990)
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