Label: DOCUSATE SODIUM capsule

  • NDC Code(s): 69618-043-01, 69618-043-10
  • Packager: Reliable 1 Laboratories LLC
  • 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 25, 2019

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  • SPL UNCLASSIFIED SECTION

    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 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 DOCTOR/PHARMACIST

    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

    Stop use and ask a doctor if

    • you have rectal bleeding or fail to have bowel movement after use of a laxative. These could be sings of a serious condition.
    • you need to use a stool softener laxative for more than 1 week
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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 divided doses
    children 2 to under 12 years of age1 softgel once daily
    children under 2 yearsask a doctor

  • OTHER SAFETY INFORMATION

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

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

  • Questions or comments ?

    Call 516-341-066 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.

  • SPL UNCLASSIFIED SECTION

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

  • SPL UNCLASSIFIED SECTION

    Distributed by: Reliable-1 Laboratories LLC Valley Stream, NY 11580 www.reliable1labs.com

  • PRINCIPLINE DISPLAY PANEL - Bottle Label 100ct

    NDC 69618-043-01

    Docusate Sodium 100 mg 100 SOFTGELS

    STOOL SOFTENER LAXATIVE

    Bottle Label 100ct front

    Bottle Label 100ct back

  • PRINCIPLINE DISPLAY PANEL - Bottle Label 1000ct

    NDC 69618-043-10

    Docusate Sodium 100 mg 1000 SOFTGELS

    STOOL SOFTENER LAXATIVE

    Bottle Label 1000ct

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69618-043
    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
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code PC1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69618-043-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2016
    2NDC:69618-043-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33404/01/2016
    Labeler - Reliable 1 Laboratories LLC (079718111)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(69618-043) , analysis(69618-043)
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