145 mg white to off-white, oval-shaped, biconvex, film-coated tablets debossed with RH38 on one side and other side plain and are available as follows:
NDC 68071-4692-9 BOTTLES OF 90
Store at 20º — 25º C (68º — 77º F) [See USP Controlled Room Temperature]. Keep out of the reach of children. Protect from moisture.
Patients should be advised:
- of the potential benefits and risks of fenofibrate tablets, USP.
- not to use fenofibrate tablets, USP if there is a known hypersensitivity to fenofibrate or fenofibric acid.
- of medications that should not be taken in combination with fenofibrate tablets, USP.
- that if they are taking coumarin anticoagulants, fenofibrate tablets, USP 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, USP.
- to take fenofibrate tablets, USP 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, USP.
- to inform their physician of any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms.
- not to breastfeed during treatment with fenofibrate tablets, USP and for 5 days after the final dose.
Sun Pharmaceutical Industries Ltd.
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512
December 2018 FDA-06
| FENOFIBRATE |
fenofibrate tablet, film coated
|Labeler — NuCare Pharmaceuticals,Inc. (010632300)|
|NuCare Pharmaceuticals,Inc.||010632300||relabel (68071-4692)|
Revised: 06/2021 NuCare Pharmaceuticals,Inc.
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