Label: DOCUSATE SODIUM capsule, liquid filled

  • 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 January 26, 2022

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  • Active ingredient (in each softgel)

    Docusate Sodium 250 mg

  • Purpose

    Stool Softener

  • Keep Out of Reach of Children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Uses

    •
    For the relief of occasional constipation.
    •
    Helps to prevent dry, hard stools.
    •
    This product generally produces a bowel movement within 12 to 72 hours.
  • Warnings

    Do not use:

    •
    If you are currently taking mineral oil, unless directed by a doctor.
    •
    When abdominal pain, nausea, or vomiting are present.
    •
    For longer than one week unless directed by a doctor.
  • Ask a doctor before use

    if you notice a sudden change in bowel habits that persists over a period of two weeks.

  • Stop use and ask a doctor

    if you have rectal bleeding or you fail to have a bowel movement after use.

  • If you are pregnant or breast-feeding,

    ask a healthcare professional before use.

  • Directions

    Adults and Children over 12 years of age

    Take orally 1 softgel preferably at bedtime for
    2-3 days or until bowel movements are normal, or as directed by a doctor.

    Children under 12 years of age

    Do not use this product for children under 12 years of age, unless directed by a doctor.
  • Other Information

    •
    Each softgel contains 13 mg of Sodium.
    •
    Keep lid tightly closed.
    •
    Store at room temperature between 15°C to 30°C (59°F to 86°F).
    •
    Do not use if printed seal under cap is broken or missing.
    •
    For identification purposes, each softgel will have an imprint that reads NV12.
  • Inactive ingredients

    FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol

  • Questions

    Call 1 (800) 447-1006

  • Package/Label Principal Display Panel

    Safecor Health


    Docusate Sodium, USP
    250 mg Each

    NDC 48433-101-01


    100 Unit Dose Softgels

    Packaged and Distributed by:

    Safecor Health, LLC

    Columbus, OH 43204

    Docusate soldium 250 mg Unit Dose Box Label
  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48433-101(NDC:54629-601)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 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 1000 (UNII: U076Q6Q621)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code NV12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48433-101-01100 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product05/01/2000
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/01/2000
    Labeler - Safecor Health, LLC (828269675)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safecor Health, LLC078805287REPACK(48433-101)
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