Label: DOCUSATE SODIUM capsule, gelatin coated

  • Category: HUMAN OTC DRUG LABEL

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 28, 2016

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  • Active ingredient

    Docusate sodium 100mg

  • Purpose

    Stool softener

  • Uses

    ■ for the prevention of dry, hard stools

    ■ for relief of occasional constipation

    This product generally produces a bowel movement within 12 to 72 hours.

  • Warnings

    Do not use

    ■ if you are currently taking mineral oil, unless directed by a doctor  

    ■ when abdominal pain, nausea, or vomiting are present 

    ■  for longer than 1 week unless directed by a doctor

    Ask a doctor before use if you

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

    Stop use and ask a doctor if you

    ■ have rectal bleeding

    ■ fail to have a bowel movement occur after use

    Pregnancy/Breastfeeding

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

  • Directions

    ■ Adults and children 12 years and over: take 1 to 3 capsules, preferably at bedtime

    ■ Children 2 to under 12 years of age: take 1 capsule at bedtime

    ■ Children under 2 years of age: ask a doctor

  • Other information

    each capsule contains: sodium 5mg

    store at room temperature 15°-30°C (59°-86°F)

  • Inactive ingredients

    FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol

  • Principal Display Panel

     Docusate Sodium

    Docusate Sodium

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-314
    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)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize8mm
    FlavorImprint Code SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68998-314-01100 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 - Marc Glassman, Inc. (094487477)
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