Fenoglide (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

FENOGLIDE (fenofibrate) Tablets 40 mg, are white to off-white oval tablets debossed “FLO” on one side and blank on the other side.

Bottle of 90 tablets, NDC 68012-490-90

FENOGLIDE (fenofibrate) Tablets 120 mg, are white to off-white oval tablets debossed “FHI” on one side and blank on the other side.

Bottle of 90 tablets, NDC 68012-495-90

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Patients should be advised:

•

of the potential benefits and risks of FENOGLIDE.

•

not to use FENOGLIDE if there is a known hypersensitivity to fenofibrate or fenofibric acid.

•

that if they are taking coumarin anticoagulants, FENOGLIDE may increase their anticoagulant effect, and increased monitoring may be necessary.

•

of medications that should not be taken in combination with FENOGLIDE.

•

to continue to follow an appropriate lipid-modifying diet while taking FENOGLIDE.

•

to take FENOGLIDE 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 FENOGLIDE.

•

to inform their physician of symptoms of liver injury (e.g., jaundice, abnormal pain, nausea, malaise, dark urine, abnormal stool, pruritus); any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms.

•

not to breastfeed during treatment with FENOGLIDE and for 5 days after the final dose.

Distributed by:

Salix Pharmaceuticals, a division of

Bausch Health US, LLC

Bridgewater, NJ 08807 USA

FENOGLIDE is a trademark of Salix Pharmaceuticals, Inc. or its affiliates.

© 2021 Salix Pharmaceuticals, Inc. or its affiliates

U.S. Patent Numbers: 7,658,944; 8,124,125; 8,481,078 and 9,173,847

9606803 70015724

Bottle LABEL – PRINCIPAL DISPLAY PANEL 40MG

NDC 68012-490-90
Fenoglide®
(fenofibrate) Tablets

40 mg

90 Tablets
Rx only
Salix

Bottle LABEL – PRINCIPAL DISPLAY PANEL 120MG

NDC 68012-495-90
Fenoglide®

(fenofibrate)

tablets

120 mg

Rx only90 Tablets

Salix

FENOGLIDE fenofibrate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68012-490 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength fenofibrate (FENOFIBRIC ACID) fenofibrate 40 mg

Inactive Ingredients Ingredient Name Strength lactose monohydrate Polyethylene Glycol 6000 Poloxamer 188 magnesium stearate

Product Characteristics Color white (white) Score no score Shape OVAL (OVAL) Size 13mm Flavor Imprint Code FLO Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68012-490-90 90 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022118 11/18/2010

FENOGLIDE fenofibrate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68012-495 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength fenofibrate (FENOFIBRIC ACID) fenofibrate 120 mg

Inactive Ingredients Ingredient Name Strength lactose monohydrate Polyethylene Glycol 6000 Poloxamer 188 magnesium stearate

Product Characteristics Color white (white) Score no score Shape OVAL (OVAL) Size 18mm Flavor Imprint Code FHI Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68012-495-90 90 TABLET in 1 BOTTLE None 2 NDC:68012-495-07 6 BOTTLE in 1 BOX contains a BOTTLE 2 7 TABLET in 1 BOTTLE This package is contained within the BOX (68012-495-07)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022118 11/18/2010

Labeler — Santarus, Inc. (104286369)

Establishment
Name	Address	ID/FEI	Operations
Catalent Pharma Solutions, LLC		829672745	MANUFACTURE (68012-490), MANUFACTURE (68012-495)

Revised: 06/2021 Santarus, Inc.