Fenofibrate (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

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 68682-490-90

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 68682-495-90

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 fenofibrate tablets.
not to use fenofibrate tablets if there is a known hypersensitivity to fenofibrate or fenofibric acid.
that if they are taking coumarin anticoagulants, fenofibrate tablets may increase their anticoagulant effect, and increased monitoring may be necessary.
of medications that should not be taken in combination with fenofibrate tablets.
to continue to follow an appropriate lipid-modifying diet while taking fenofibrate tablets.
to take fenofibrate tablets 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 tablets.
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 fenofibrate tablets and for 5 days after the final dose.

Distributed by:
Oceanside Pharmaceuticals, a division of
Bausch Health US, LLC
Bridgewater, NJ 08807 USA
© 2021 Bausch Health Companies Inc. or its affiliates
U.S. Patent Numbers: 7,658,944; 8,124,125; 8,481,078 and 9,173,847

9746202 70015804

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

40mglabel
(click image for full-size original)

NDC 68682-490-90

RX only

FENOFIBRATE

TABLET S

40 mg

90 Tablets

OCEANSIDE

PHARMACEUTICALS

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

120label
(click image for full-size original)
FENOFIBRATE fenofibrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68682-490
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:68682-490-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022118 03/16/2021
FENOFIBRATE fenofibrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68682-495
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:68682-495-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA022118 03/16/2021
Labeler — Oceanside Pharmaceuticals (832011691)
Establishment
Name Address ID/FEI Operations
Catalent Pharma Solutions 829672745 MANUFACTURE (68682-490), MANUFACTURE (68682-495)
Establishment
Name Address ID/FEI Operations
Packaging Coordinators Inc 078525133 PACK (68682-490), PACK (68682-495), LABEL (68682-490), LABEL (68682-495)

Revised: 06/2021 Oceanside Pharmaceuticals

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.