Label: DOCUSATE SODIUM capsule, liquid filled

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

Drug Label Information

Updated January 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 noticed 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.
    • You fail to have a bowel movement after use.

    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.

  • Directions

    Adult and Children over 12 years of ageTake 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 ageDo 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).
  • Inactive ingredients

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

  • How Supplied

    NDC 68094-052-61
    Unit Dose Packages of 100 Softgels (10×10) per Carton

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    National Vitamin Company
    Casa Grande, AZ 85122

    Packaged by:
    Precision Dose, Inc.
    South Beloit, IL 61080

  • QUESTIONS

    For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

  • SPL UNCLASSIFIED SECTION

    LI1459 Rev. 06/21

  • PRINCIPAL DISPLAY PANEL - 250 mg Softgel Blister Pack Carton

    Precision Dose™

    NDC 68094-052-61
    Unit Dose

    Docusate Sodium, USP
    250 mg Softgels

    100 Softgels
    (10 x 10)

    (in each softgel)
    Docusate Sodium 250 mg Stool Softener

    Each softgel contains 13 mg of Sodium.

    USUAL DOSE: SEE ENCLOSED INSERT.

    Store at room temperature between
    15°C to 25°C (59°F to 77°F).

    Keep out of reach of children.

    Hospital Use Only.

    LC1458
    R0

    Packaged by:
    Precision Dose, Inc.
    South Beloit, IL 61080

    PRINCIPAL DISPLAY PANEL - 250 mg Softgel Blister Pack Carton
  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68094-052(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, UNSPECIFIED (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:68094-052-6110 in 1 CARTON09/30/202210/31/2024
    1NDC:68094-052-5910 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00709/30/202210/31/2024
    Labeler - Precision Dose, Inc. (035886746)
    Establishment
    NameAddressID/FEIBusiness Operations
    Precision Dose, Inc.035886746REPACK(68094-052)
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