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

  • NDC Code(s): 53345-018-01, 53345-018-02
  • 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 December 10, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each softgel)

    Docusate Sodium 100 mg

  • Purpose

    Stool softener

  • Uses

    • relieves occasional constipation (irregularity)
    • generally produces a bowel movement in 12 to 72 hours
  • Warnings

    Do not use

    • if you are presently taking mineral oil, unless told to do so by a doctor                                

    Ask a doctor before use if you have

    • stomach pain
    • nausea
    • vomiting
    • noticed a sudden change in bowel movements that lasts over 2 weeks

    Stop use and ask a doctor if

    • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
    • you need to use a stool softener 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 only by mouth. Doses may be taken as a single daily dose or in divided doses.

    adults and children 12 years and over

    take 1 to 3 softgels daily

    children 2 to under 12 years of age

    take 1 softgel daily

    children under 2 years

    ask a doctor

  • Other information

    • each softgel contains: sodium 5 mg
    • VERY LOW SODIUM
    • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
  • Inactive ingredients

    Black ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special and purified water 

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

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    DOCUSATE SODIUM CAPSULES, 100 mg
    Quantity : 20000 Capsules
    NDC. No : 53345-018-01

    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

    Shipper Label 20000

    DOCUSATE SODIUM CAPSULES, 100 mg
    Quantity : 15000 Capsules
    NDC. No : 53345-018-02

    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.
    4.Store at 15-30°C (59-86°F)

    CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING

    Shipper Label 15000

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 100MG TWO-TONE 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53345-018
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    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)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorred, white (Two-Tone) Scoreno score
    ShapeCAPSULE (OVAL) Size13mm
    FlavorImprint Code PC18
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53345-018-011 in 1 BOX12/23/2013
    120000 in 1 BAG; Type 0: Not a Combination Product
    2NDC:53345-018-021 in 1 BOX12/23/2013
    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 finalpart33412/23/2013
    Labeler - Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. (421293287)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.421293287MANUFACTURE(53345-018) , ANALYSIS(53345-018)
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