Label: DOCUSATE SODIUM capsule, liquid filled

  • NDC Code(s): 11788-015-00
  • Packager: AiPing Pharmaceutical, Inc.
  • 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 11, 2019

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  • ACTIVE INGREDIENTS (IN EACH SOFTGEL)

    Docusate Sodium 100 mg

  • PURPOSE

    Stool softener

  • USES

    • relieves occasional constipation (irregularity)
    • generally produces 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 habits 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 1-3 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 6 mg
    • Store at room temperature 15-30°C
  • INACTIVE INGREDIENTS

    Black edible ink, D&C Red #33, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution and titanium dioxide.

  • PRINCIPAL DISPLAY PANEL-SHIPPING LABEL

    Docusate Sodium Softgels, USP 100mg (Double-Tone)

    Quantity : 19000 Softgels

    NDC. No : 11788-015-00

    WARNING:

    KEEP OUT OF THE REACH OF CHILDREN. THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY. CONTENTS SHOULD BE REPACKAGED IMMEDIATELY AND LABELED IN STRICK CONFORMANCE WITH THE FOOD DRUG & COSMETIC ACT AND REGULATIONS THEREUNDER.

    dss label

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11788-015
    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
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Colorred (Double-Tone: white and clear red) Scoreno score
    ShapeOVALSize13mm
    FlavorImprint Code AP015
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11788-015-001 in 1 BOX11/01/2018
    119000 in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33411/01/2018
    Labeler - AiPing Pharmaceutical, Inc. (079674526)
    Registrant - AiPing Pharmaceutical, Inc. (079674526)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anshi Pharmaceutical (Zhongshan) Inc.528101821manufacture(11788-015) , analysis(11788-015) , label(11788-015) , pack(11788-015)
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