Label: DOCUSATE SODIUM capsule, liquid filled

  • 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 September 1, 2022

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

  • WARNINGS

    Ask a doctor before use if you

    • have stomach pain, nausea or vomiting

    • have a sudden change in bowel habits that persists over a period of 2 weeks

    • are presently taking mineral oil

    Stop use and ask a doctor if

    • you need to use a laxative longer than 1 week

    • you have rectal bleeding or fail to have a bowel movement. These

    could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • ACTIVE INGREDIENT

    Docusate Sodium 100 mg

  • PURPOSE

    Stool Softener Laxative

  • INDICATIONS & USAGE

    relieves occasional constipation (irregularity)

    generally produces bowel movement in 12 to 72 hours

  • INACTIVE INGREDIENT

    FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water.

  • 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.

  • DOSAGE & ADMINISTRATION

    each softgel contains: sodium 7 mg. Very low sodium

  • PRINCIPAL DISPLAY PANEL

    72189-377-30

  • PRINCIPAL DISPLAY PANEL

    72189-377-60

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72189-377(NDC:57896-401)
    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)  
    GELATIN (UNII: 2G86QN327L)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MANNITOL (UNII: 3OWL53L36A)  
    Product Characteristics
    Colorred (reddish) Scoreno score
    ShapeOVALSize12mm
    FlavorImprint Code SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72189-377-3030 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2022
    2NDC:72189-377-6060 in 1 BOTTLE; Type 0: Not a Combination Product08/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/31/2022
    Labeler - Direct_Rx (079254320)
    Registrant - Direct_Rx (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    Direct_Rx079254320repack(72189-377)