Label: DOCUSATE SODIUM capsule, liquid filled

  • NDC Code(s): 53345-008-01, 53345-008-02
  • Packager: Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2024

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  • 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

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    Shipping Label for 20000ctDOCUSATE SODIUM CAPSULES, 100 mg
    Quantity : 15000 Capsules
    NDC. No : 53345-008-02

    IMPORTANT:
    1.Inspect immediately upon receipt.
    2.This is a bulk shipment, intended for further processing only.
    3.Protect from heat, humidity, and light. Do not refrigerate.

    CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    DOCUSATE SODIUM CAPSULES, 100 mg
    Quantity : 15000 Capsules
    NDC. No : 53345-008-02

    IMPORTANT:
    1.Inspect immediately upon receipt.
    2.This is a bulk shipment, intended for further processing only.
    3.Protect from heat, humidity, and light. Do not refrigerate.

    CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

    Shipping Label for 15000ct

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (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:53345-008-011 in 1 BOX04/15/2013
    120000 in 1 BAG; Type 0: Not a Combination Product
    2NDC:53345-008-021 in 1 BOX04/15/2013
    215000 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00704/15/2013
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287manufacture(53345-008)
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