Label: DOCUSATE SODIUM capsule, liquid filled

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

Drug Label Information

Updated December 8, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each liquid-filled capsule)

    Docusate Sodium 100 mg 

  • Purpose

    Stool Softner laxative

  • Uses

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

    Warnings

  • Ask a doctor before use if you have

    • stomach pain, nausea or vomittiong
    •  a sudden change in bowel habits that lasts more than 2 weeks
  • DO NOT USE

    Do not use if you are presently taking mineral oil, unless told to do so by a doctor

  • Stop use and ask a doctor if you

    • you have rectal bleeding ot no bowel movement after using this product. These could be signs of a serious condition.
    • yo need to use 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 with a glass of water

    take by mouth. Doses may be taken as a single daily dose or in divided doses.

    Adults and children 12 years and over

    take 1 to 3 capsules daily. 

    Children 2 to under 12 years of age

    1 capsule daily.

    Children under 2 years of age

    Ask a doctor

  • Other information

    • Store at room temperature 20-25°C  (68-77°F) 
    • protect from excessive humidity
    • do not use this product of the safety seal under the cap is torn or missing
  • Inactive ingredients

    FD&C Red#40, FD&C Yellow#6, gelatin,glycerin, polyethylene glycol 400, propylene glycol, povidone, purified water, sorbitol solution, titanium dioxide.

  • Questions or comments?

    1-888-333-9792

  • PRINCIPAL DISPLAY PANEL

    Compare to Dulcolax ® Stool Softener active ingredient *

    GENTLE STOOL SOFTENER

    DOCUSATE SODIUM 100 mg / STOOL SOFTENER LAXATIVE

    25 LIQUID GELS

    GSS

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-8991
    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
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 125
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-8991-251 in 1 PACKAGE12/22/2020
    125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00712/22/2020
    Labeler - WALGREEN COMPANY (008965063)
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