FENOFIBRATE tablet MONTELUKAST SODIUM tablet, chewable

Montelukast Sodium by

Drug Labeling and Warnings

Montelukast Sodium by is a Other medication manufactured, distributed, or labeled by Food and Drug Administration. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Type		Item Code (Source)	NDC: 43353-248
Reporting Period	20171205-

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FENOFIBRATE (UNII: U202363UOS) (FENOFIBRIC ACID - UNII:BGF9MN2HU1)	FENOFIBRATE	48 mg

MONTELUKAST SODIUM 
montelukast sodium tablet, chewable

Product Information
Product Type		Item Code (Source)	NDC: 43353-252
Reporting Period	20171205-

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MONTELUKAST SODIUM (UNII: U1O3J18SFL) (MONTELUKAST - UNII:MHM278SD3E)	MONTELUKAST	5 mg

Labeler - Food and Drug Administration (927645523)