Fenofibrate: Package Insert and Label Information

FENOFIBRATE- fenofibrate tablet
MONTELUKAST SODIUM — montelukast sodium tablet, chewable
Food and Drug Administration

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

FENOFIBRATE
fenofibrate tablet
Product Information
Product Type Item Code (Source) NDC:43353-248
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 48 mg
MONTELUKAST SODIUM
montelukast sodium tablet, chewable
Product Information
Product Type Item Code (Source) NDC:43353-252
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MONTELUKAST SODIUM (MONTELUKAST) MONTELUKAST 5 mg
Labeler — Food and Drug Administration (927645523)

Revised: 12/2017 Food and Drug Administration

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