Fenofibrate (Page 7 of 7)
16 HOW SUPPLIED/STORAGE AND HANDLING
Fenofibrate tablets USP are available in two strengths:
54 mg – White to off white, oval-shaped, film-coated, unscored tablet, debossed with “CL 25” on one side and blank on the other side. Available in bottles of 90 (NDC 69367-257-09).
160 mg — White to off white, oval-shaped, film-coated, unscored tablet, debossed with “CL 26” on one side and blank on the other side. Available in bottles of 90 (NDC 69367-254-09) and 500 (NDC 69367-254-05).
Storage
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
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.
- of medications that should not be taken in combination with fenofibrate tablets.
- that if they are taking coumarin anticoagulants, fenofibrate tablets may increase their anti-coagulant effect, and increased monitoring may be necessary.
- to continue to follow an appropriate lipid-modifying diet while taking fenofibrate tablets.
- to take fenofibrate tablets once daily with a meal 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 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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Distributed by:
Westminster Pharmaceuticals, LLC
Nashville, TN 37217
Revised: September, 2021
LBL359
PRINCIPAL DISPLAY PANEL — 54 mg Tablet Bottle Label
NDC 69367-257-09
Rx Only
Fenofibrate
Tablets, USP
54 mg
90 Tablets
Westminster
Pharmaceuticals
PRINCIPAL DISPLAY PANEL -160 mg Container Label — 500 Count
NDC 69367-254-05
Fenofibrate Tablets USP
160 mg
Rx only
500 Tablets
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| FENOFIBRATE fenofibrate tablet, film coated | ||||||||||||||||||
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| Labeler — Westminster Pharmaceuticals, LLC (079516651) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Austarpharma, LLC | 362785011 | MANUFACTURE (69367-254), MANUFACTURE (69367-257) | |
Revised: 04/2020 Westminster Pharmaceuticals, LLC
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