Label: STOOL SOFTENER- docusate sodium capsule

  • NDC Code(s): 69168-420-01, 69168-420-30, 69168-420-81
  • Packager: Allegiant Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2020

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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

    you have

    • 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 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

    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 1-3 softgels, daily. Doses 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: 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 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

  • Questions

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

  • Principal Display Panel

    Stool Softener

    Stool Softener


  • INGREDIENTS AND APPEARANCE
    STOOL SOFTENER 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-420
    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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred, whiteScoreno score
    ShapeCAPSULESize13mm
    FlavorImprint Code PC18
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-420-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/10/2015
    2NDC:69168-420-81400 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2021
    3NDC:69168-420-3030 in 1 BOTTLE; Type 0: Not a Combination Product11/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00704/10/2015
    Labeler - Allegiant Health (079501930)
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