Label: STOOL SOFTENER- docusate sodium 100 mg capsule

  • NDC Code(s): 69168-314-01, 69168-314-30
  • Packager: Allegiant Health
  • 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 26, 2018

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

  • Active ingredient

    Docusate Sodium 100 mg

  • Purpose

    Stool softener

  • Uses

    • 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 you

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

    Stop use and ask a doctor if you

     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 stool softener laxative for more than 1 week      

    If pregnant or breast-feeding

    If pregnant or breast-feeding, 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. 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 ask a doctor. 
  • Other Information

    • each softgel contains: sodium 5mg

    • VERY LOW SODIUM
    • store at 25°C (77°F) excursions permitted between 15°– 30°C (59°–86°F) 
  • Inactive Ingredients

    • Black edible ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special.
  • Package/Label Principal Display Panel

    Docusate Sodium

    Docusate Sodium


  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium 100 mg capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-314
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-314-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2014
    2NDC:69168-314-3030 in 1 BOTTLE; Type 0: Not a Combination Product12/23/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33412/23/2014
    Labeler - Allegiant Health (079501930)