Label: DOCUSATE SODIUM- 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 April 1, 2016

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each softgel)

    Docusate sodium 100 mg

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  • Purpose

    Stool softener laxative

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  • Uses

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

    Do not use if you are presently taking mineral oil, unless directed to do so by a doctor

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  • 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
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  • 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.

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  • 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
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  • PREGNANCY OR BREAST FEEDING

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

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  • 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.

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  • Directions

    adults and children 12 years and over take 1 -3 softgels once daily or in divided doses
    children 2 to under 12 years of age 1 softgel once daily
    children under 2 years ask a doctor

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  • OTHER SAFETY INFORMATION

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

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  • Questions or comments ?

    Call 516-341-066 8:30 am - 4:30 pm ET, Monday - Friday

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  • SPL UNCLASSIFIED SECTION

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

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  • SPL UNCLASSIFIED SECTION

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

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL

    NDC 69618-043-10

    Docusate Sodium 100 mg

    STOOL SOFTENER

    LAXATIVE

    1000 SOFTGELS

    DOCUSATE SODIUM 100MG

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  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69618-043
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    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 GLYCOLS (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color red Score no score
    Shape OVAL Size 13mm
    Flavor Imprint Code PC1
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69618-043-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2016
    2 NDC:69618-043-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/2016
    Image of Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 04/01/2016
    Labeler - Reliable 1 Laboratories LLC (079718111)
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