Fenofibrate (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-4957

NDC: 50090-4957-0 90 TABLET, COATED in a BOTTLE

17 PATIENT COUNSELING INFORMATION

Patients should be advised:

• of the potential benefits and risks of fenofibrate.
• not to use fenofibrate if there is a known hypersensitivity to fenofibrate or fenofibric acid.
• of medications that should not be taken in combination with fenofibrate.
• that if they are taking coumarin anticoagulants, fenofibrate may increase their anti-coagulant effect, and increased monitoring may be necessary.
• to continue to follow an appropriate lipid-modifying diet while taking fenofibrate.
• to take fenofibrate once daily, without regard to food, at the prescribed dose, swallowing each tablet whole.
• to return to their physician’s office for routine monitoring.
• to inform their physician of all medications, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also be advised to inform their physicians prescribing a new medication that they are taking fenofibrate.
• to inform their physician of any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms.
• not to breastfeed during treatment with finofibrate and for 5 days after the final dose.

Distributed by:

Aurobindo Pharma USA, Inc.

279 Princeton-Hightstown Road

East Windsor, NJ 08520

Manufactured by:

Aurobindo Pharma Limited

Hyderabad-500 038, India

Fenofibrate

Label Image

FENOFIBRATE fenofibrate tablet, coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4957(NDC:65862-769) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FENOFIBRATE (FENOFIBRIC ACID) FENOFIBRATE 145 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) HYPROMELLOSE 2910 (3 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (15 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLOXAMER 407 SILICON DIOXIDE SODIUM LAURYL SULFATE SUCROSE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE

Product Characteristics Color WHITE Score no score Shape OVAL (Biconvex) Size 18mm Flavor Imprint Code T;16 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50090-4957-0 90 TABLET, COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA205118 05/05/2016

Labeler — A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Operations
A-S Medication Solutions		830016429	RELABEL (50090-4957)

Revised: 03/2020 A-S Medication Solutions