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
  • 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 November 6, 2019

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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 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.

    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 not finalpart33404/15/2013
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(53345-008) , ANALYSIS(53345-008)
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