Label: DOCUSATE SODIUM capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 30, 2024

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg

  • Purpose

    Stool softener

  • Uses

    • for temporary relief of occasional constipation and irregularity
    • this product generally produces bowel movement in 12 to 72 hours
  • Warnings

    Ask a doctor before use if you have

    • stomach pain, nausea or vomitting
    • a sudden change in bowel habits that lasts more than 2 weeks

    Ask a doctor or pharmacist before use if you arepresently taking mineral oil

    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 to use a laxative for more than 1 week

    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.

  • Directions

    take with a glass of water

    Adults and children 12 years and over

    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

    1 softgel daily

    children under 2 years of age

    ask a doctor

  • Other information

    • each softgel contains: sodium 5 mg
    • store at room temperature 15°-30°C (59°-86°F)
    • protect from excessive humidity
  • Inactive ingredients

    FD&C Red # 40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, citric acid, purified water and white edible ink

    Manufactured by:
    Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
    Wuhan, Hubei
    430206, China

  • HOW SUPPLIED

    Product: 50090-7479

    NDC: 50090-7479-1 100 CAPSULE, LIQUID FILLED in a BOTTLE, PLASTIC

    NDC: 50090-7479-4 30 CAPSULE, LIQUID FILLED in a BOTTLE, PLASTIC

  • DOCUSATE SODIUM

    Label Image
  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-7479(NDC:53345-008)
    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
    RED 40 (UNII: WZB9127XOA)  
    KI5 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AQUA (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    ColorredScoreno score
    ShapeCAPSULE (OVAL) Size13mm
    FlavorImprint Code PC1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-7479-430 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/20/2024
    2NDC:50090-7479-1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/20/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00704/15/2013
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-7479)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!