Label: DOCUSATE SODIUM capsule

  • 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 August 17, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each softgel)

    Docusate sodium 100 mg

  • PURPOSE

    Purpose

    Stool softener laxative

  • INDICATIONS & USAGE

    Uses

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

    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. These could be signs of a serious condition.
    • you need to use stool softner 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.

  • DOSAGE & ADMINISTRATION

    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

  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

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

  • QUESTIONS

    Questions or comments? Call 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday

  • SPL UNCLASSIFIED SECTION

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

    *Reliable-1 Laboratories LLC is not affiliated with the owner of the trademark Colace®

    Distributed by: Reliable-1 Laboratories LLC Valley Stream, NY 11580

    www.reliable1labs.com

    Made in Romania

  • PRINCIPAL DISPLAY PANEL

    NDC 69618-044-10

    *Compare to the active ingredient in Colace®

    Reliable-1™ LABORATORIES

    Docusate Sodium 100 mg

    STOOL SOFTENER LAXATIVE

    1000 SOFTGELS

    Label

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-044
    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
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code SCU1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-044-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2017
    2NDC:69618-044-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33403/01/2017
    Labeler - Reliable-1 Laboratories LLC (079718111)
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