FENOFIBRATE (Page 6 of 6)
16 HOW SUPPLIED/STORAGE AND HANDLING
Fenofibrate tablets, USP are available in the following strengths and configuration
Fenofibrate tablets, USP are available in the following strengths and configurations:
Fenofibrate tablets, USP 145 mg
White to off white coloured, oval shaped, biconvex film coated tablets, debossed with ‘Cipla’ on one side and code ‘458’ on other side.
Available:
Cartons of 30 tablets (10 tablets per blister pack x 3), NDC 0904-7161-04
Cartons of 100 tablets (10 tablets per blister pack x 10), NDC 0904-7161-61
Storage
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature].
Keep out of the reach of children. Protect from moisture.
17 PATIENT COUNSELING INFORMATION
Patients should be advised:
- •
- 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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- of medications that should not be taken in combination with fenofibrate tablets.
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- 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, 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, abdominal pain, nausea, malaise, dark urine, abnormal stool, pruritus); any muscle pain, tenderness, or weakness; or any other new symptoms.
- •
- not to breastfeed during treatment with fenofibrate tablets and for 5 days after the final dose.
Manufactured by:
Cipla Ltd,
Indore SEZ, Pithampur, India
Manufactured for:
Cipla USA, Inc.
10 Independence Boulevard, Suite 300
Warren, NJ 07059
Distributed By:
MAJOR® PHARMACEUTICALS
Livonia, MI 48152
Refer to package label for Distributor’s NDC Number
Revised: 6/2021
Package/Label Display Panel
Fenofibrate Tablets, USP
145 mg
100 Tablets
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Labeler — Major Pharmaceuticals (191427277) |
Revised: 11/2021 Major Pharmaceuticals
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