Label: DOCUSATE SODIUM capsule, liquid filled

  • NDC Code(s): 54629-601-01, 54629-601-99
  • Packager: National Vitamin Company
  • Category: HUMAN OTC DRUG LABEL

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 10, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • 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.

  • 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 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) 682-9862

  • Package/Label Principal Display Panel

    NDC 54629-601-01
    Life-Line®
    Docusate Sodium, USP
    Stool Softener
    250 mg Each
    100 Softgels

    Manufactured and Distributed by
    National Vitamin Company
    Casa Grande, AZ 85122

    Bottle Label

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    DOCUSATE SODIUM 
    docusate sodium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:54629-601-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/01/2000
    2NDC:54629-601-991000 in 1 BOTTLE; 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 - National Vitamin Company (102098324)
    Establishment
    NameAddressID/FEIBusiness Operations
    National Vitamin Company102098324MANUFACTURE(54629-601)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!