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:
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- of the potential benefits and risks of fenofibrate tablets.
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- not to use fenofibrate tablets if there is a known hypersensitivity to fenofibrate or fenofibric acid.
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- that if they are taking coumarin anticoagulants, fenofibrate tablets may increase their anticoagulant effect, and increased monitoring may be necessary.
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- of medications that should not be taken in combination with fenofibrate tablets.
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- to continue to follow an appropriate lipid-modifying diet while taking fenofibrate tablets.
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- to take fenofibrate tablets once daily, without regard to food, at the prescribed dose, swallowing each tablet whole.
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- to return to their physician’s office for routine monitoring.
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- 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.
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- 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.
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- 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
NDC 68682-490-90
RX only
FENOFIBRATE
TABLET S
40 mg
90 Tablets
OCEANSIDE
PHARMACEUTICALS
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
FENOFIBRATE fenofibrate tablet | ||||||||||||||||||
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FENOFIBRATE fenofibrate tablet | ||||||||||||||||||
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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
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