Label: DOCUSATE SODIUM capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL

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.

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Updated October 24, 2021

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  • SPL UNCLASSIFIED SECTION

    DOCUSATE SODIUM- docusate sodium capsule Marlex Pharmaceuticals, Inc.

    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.

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    Docusate Sodium 100 mg

    Drug Facts

  • Active ingredient (in each softgel)

    Docusate sodium 100 mg

  • Purpose

    Stool softener laxative

  • 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 directed 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

    Ask a doctor or pharmacist before use if you are

    taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

    Stop use and ask a doctor if

    • you have rectal bleeding or fail to have a bowel movement after use of a laxative.
    • you need to use stool softner laxative for more than 1 week

    These could be sings of a serious condition.

    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

    adults and children 12 years and overtake 1 - 3 softgels once daily or in divded doses
    children 2 to under 12 years of age1 softgel once daily
    children under 2 yearsask a doctor
  • Other informaiton

    • each softgel contains: s odium 7 mg
    • store at room temperature 15º-25ºC (59º-77ºF) and avoid excessive heat
  • Inactive ingredients

    FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400 NF, purified water, sorbitol

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

    *Marlex Pharmaceuticals, Inc., is not affiliated with the owner of the trademark Colace®

    Distributed by:
    Marlex Pharmaceuticals, Inc.
    New Castle, DE 19720

    Made in Romania

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0111-01
    Docusate Sodium
    100 mg
    100     Softgels

    PRINCIPAL DISPLAY PANEL NDC 10135-0111-01 Docusate Sodium 100 mg 100 Softgels

    PRINCIPAL DISPLAY PANEL NDC 10135-0111-01 Docusate Sodium 100 mg 100 Softgels

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-111
    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 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10135-111-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/01/2017
    Labeler - Marlex Pharmaceuticals Inc (782540215)
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