Label: DOCUSATE SODIUM capsule, liquid filled

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 22, 2023

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  • Active Ingredient (in each softgel)

    Docusate Sodium 250 mg

  • Purpose

    Stool Softener

  • 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 pregnant or breast-feeding,

    ask a healthcare professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away (800) 222-1222.

  • 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.
    • Store at room temperature between 15°C to 25°C (59°F to 77°F).
    • Do not use if seal under cap is broken or missing.
  • Inactive Ingredients

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

  • Questions

    Quwstions of Comments Call 1 (800) 682-9862

  • HOW SUPPLIED

    For identification purposes, each softgel will have an imprint that reads NV12.

    NDC 72789-166-60 Bottles of 60 softgels.

  • Package/Label Principal Display Panel

    Docusate Sodium, USP
    Stool Softener
    250 mg Each

    72789166 Label
  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72789-166(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
    SORBITOL (UNII: 506T60A25R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code NV12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72789-166-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/10/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00705/01/2000
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(72789-166)
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