Label: DOCUSATE SODIUM 100MG- docusate sodium 100mg- docusate sodium capsule, liquid filled capsule, liquid filled

  • NDC Code(s): 84328-001-01, 84328-001-02
  • Packager: SHANDONG ROSEMED BIOOHARM LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 26, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

  • Active ingredient (in each s oftgel)

    Docusate Sodium 100 mg

  • Purpose

    Stool softener laxative

  • 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 are presently 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.

  • Directions

    take with a glass of water

    adults and children 12 years and over1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
    children 2 and under 12 years of age1 softgel daily
    children under 2 years of ageask 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

  • Dosage & administraton

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

  • Indications & usage section

    adults and children 12 years and over1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.
    children 2 and under 12 years of age1 softgel daily
    children under 2 years of ageask a doctor

  • keep out of reach of children

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

  • Drug Label Information

    DOCUSATE SODIUM CAPSULES, 100 mg

    Quantity : 20000 Capsules
    NDC. No : 84328-001

    IMPORTANT:

    Inspect immediate upon receipt.
    This is a bulk shipment, intended for further processing only.
    Protect from heat, humidity, and light. Do not refrigerate.
    Store at 15-30°C (59-86°F)
    CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

    1

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 100MG 
    docusate sodium 100mg- docusate sodium capsule, liquid filled capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84328-001
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorredScorescore with uneven pieces
    ShapeCAPSULE (OVAL) Size13mm
    FlavorImprint Code 655
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84328-001-011 in 1 BOX05/16/2024
    120000 in 1 BAG; Type 0: Not a Combination Product
    2NDC:84328-001-021 in 1 BOX05/17/2024
    215000 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00805/16/2024
    Labeler - SHANDONG ROSEMED BIOOHARM LLC (416829348)
    Registrant - SHANDONG ROSEMED BIOOHARM LLC (416829348)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHANDONG ROSEMED BIOOHARM LLC416829348manufacture(84328-001)
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

More Info on this Drug

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