Label: FENOFIBRATE tablet
MONTELUKAST SODIUM tablet, chewable

  • Packager: Food and Drug Administration
  • Category: INDEXING - WARNING LETTER ALERT
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2017

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

View All Sections
  • SPL INDEXING DATA ELEMENTS SECTION

  • SPL UNCLASSIFIED SECTION

    https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm588722.htm

  • INGREDIENTS AND APPEARANCE
    FENOFIBRATE 
    fenofibrate tablet
    Product Information
    Product TypeItem Code (Source)NDC:43353-248
    Reporting Period20171205-
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FENOFIBRATE (UNII: U202363UOS) (FENOFIBRIC ACID - UNII:BGF9MN2HU1) FENOFIBRATE48 mg
    MONTELUKAST SODIUM 
    montelukast sodium tablet, chewable
    Product Information
    Product TypeItem Code (Source)NDC:43353-252
    Reporting Period20171205-
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E) MONTELUKAST5 mg
    Labeler - Food and Drug Administration (927645523)
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!