Label: DOCUSATE CALCIUM 240 MG SODIUM FREE- docusate calcium capsule, liquid filled

  • NDC Code(s): 54629-640-01
  • Packager: National Vitamin Company
  • 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 10, 2020

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

View All Sections
  • Active ingredient

    Docusate Calcium 240 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.
    •
    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 immediately.

  • Directions

    Adults and Children over 12 years of age

    Take orally 1 softgel daily for 2 to 3 days or until bowl 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

    •
    Keep lid tightly closed.
    •
    Store at room temperature between 15ºC to 25ºC (59ºF to 77ºF).
    •
    Do not use if either seal is broken or missing.
  • Inactive Ingredients

    Corn Oil, FD&C Blue #1, FD&C Red #40, Gelatin, Glycerin, Ink (Edible), Sorbitol Special.

  • Questions or Comments

    Call 1 (800) 682-9862

  • Package/Label Principal Display Panel

    NDC 54629-0640-01

    LIFE-LINE®

    DOCUSATE
    CALCIUM
    SODIUM-FREE
    STOOL SOFTENER
    240 mg Each
    100 Softgels

    LIFE-LINE VITAMINS
    U.S.A.
    Since 1974

    Manufactured and Distributed by
    NATIONAL VITAMIN COMPANY
    Casa Grande, AZ 85122

    Label

    Label

  • INGREDIENTS AND APPEARANCE
    DOCUSATE CALCIUM 240 MG SODIUM FREE 
    docusate calcium capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54629-640
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG) DOCUSATE CALCIUM240 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN OIL (UNII: 8470G57WFM)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code NV02
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54629-640-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33402/01/2016
    Labeler - National Vitamin Company (102098324)
    Registrant - National Vitamin Company (102098324)
    Establishment
    NameAddressID/FEIBusiness Operations
    National Vitamin Company102098324MANUFACTURE(54629-640) , ANALYSIS(54629-640)
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, PubMed, Biochemical Data Summary

More Info on this Drug

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