Label: STOOL SOFTENER- docusate sodium capsule, liquid filled

  • NDC Code(s): 69168-424-32, 69168-424-81
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 20, 2021

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  • Active ingredient(s)

    Docusate sodium 100mg

  • Purpose

    Stool softener

  • Use(s)

    •  relieves occasional constipation (irregularity)
    •  generally produces bowel movement in 12 to 72 hours
  • 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

    • stomach pain
    • nausea
    • vomiting
    • notice a sudden change in bowel habits that lasts over 2 weeks

    Stop use and ask a doctor if

    • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
    • you need a laxative for more than 1 week

    Pregnancy/Breastfeeding

    ask a health professional before use.

    Keep out of reach of children

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

  • Directions

    Take only by mouth.

    Adults and children 12 years and over: take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.

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

    Children under 2 years of age: ask a doctor

  • Other information

    • each softgel contains: sodium 5mg
    • VERY LOW SODIUM
    • do not use if imprinted safety seal under cap is broken or missing
  • Storage

    Store at room temperature 15°-30°C (59°-86°F), protect from excessive humidity.

  • Inactive ingredients

    Anhydrous citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol,

    propylene glycol, purified water, sorbitol sorbitan solution and white edible ink.

  • Questions

    Call 1-888-952-0050 Monday to Friday 9am-5pm

  • Principal Display Panel

    Stool Softener

    Stool Softener


  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-424
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULESize13mm
    FlavorImprint Code PC1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-424-81400 in 1 BOTTLE; Type 0: Not a Combination Product04/20/2021
    2NDC:69168-424-32100 in 1 BOTTLE; Type 0: Not a Combination Product05/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00701/28/2015
    Labeler - Allegiant Health (079501930)
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