Label: FENOFIBRIC ACID tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application Authorized Generic

Drug Label Information

Updated December 30, 2021

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use fenofibric acid tablets safely and effectively. See full prescribing information for fenofibric acid tablets. Fenofibric Acid ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Severe Hypertriglyceridemia - Fenofibric acid tablets are indicated as adjunctive therapy to diet for treatment of severe hypertriglyceridemia (≥ 500 mg/dL). Improving glycemic control in ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 General Considerations - Fenofibric acid tablets can be given without regard to meals. Patients should be advised to swallow fenofibric acid tablets whole. Do not crush, dissolve or chew ...
  • 3 DOSAGE FORMS AND STRENGTHS
    35-mg: White, round tablets. Debossed "AR 787". 105-mg: White, modified oval tablets. Debossed "AR 788".
  • 4 CONTRAINDICATIONS
    Fenofibric acid tablets are contraindicated in: patients with severe renal impairment, including those receiving dialysis [see Clinical Pharmacology (12.3)]. patients with active liver disease ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Mortality and Coronary Heart Disease Morbidity - The effect of fenofibric acid tablets on coronary heart disease morbidity and mortality and non-cardiovascular mortality has not been ...
  • 6 ADVERSE REACTIONS
    6.1 Clinical Trials Experience - Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly ...
  • 7 DRUG INTERACTIONS
    7.1 Coumarin Anticoagulants - Potentiation of coumarin-type anticoagulant effects has been observed with prolongation of the PT/INR. Caution should be exercised when coumarin anticoagulants are ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse ...
  • 10 OVERDOSAGE
    There is no specific treatment for overdose with fenofibric acid tablets. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical ...
  • 11 DESCRIPTION
    Fenofibric acid is a lipid regulating agent available as tablets for oral administration. Each tablet contains 35 mg or 105 mg of fenofibric acid. The chemical name for fenofibric acid is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The active moiety of fenofibric acid tablets is fenofibric acid. The pharmacological effects of fenofibric acid in both animals and humans have been extensively studied ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Two dietary carcinogenicity studies have been conducted in rats with fenofibrate. In the first 24-month study, Wistar rats were ...
  • 14 CLINICAL STUDIES
    14.1 Severe Hypertriglyceridemia - The effects of fenofibrate on serum triglycerides were studied in two randomized, double-blind, placebo-controlled clinical trials of 147 hypertriglyceridemic ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Fenofibric acid tablets 35 mg, are white, round tablets, debossed "AR 787" on one side and blank on the other side.  Bottles of 30 -  NDC 72834-035-30 - Fenofibric acid tablets 105 mg, are ...
  • 17 PATIENT COUNSELING INFORMATION
    Patients should be advised: of the potential benefits and risks of fenofibric acid tablets. not to use fenofibric acid tablets if there is a known hypersensitivity to fenofibrate or fenofibric ...
  • SPL UNCLASSIFIED SECTION
    TriCor® is a registered trademark of Abbott Laboratories.  Manufactured for:  Sarras Health LLC -  Athens, GA 30601 - Revised 09/2019
  • ———PRINCIPAL DISPLAY PANEL - 35 mg Tablet———
    NDC: 72834-035-30 - Rx Only - Fenofibric - Acid Tablets - 35 - mg - 30 tablets - sarras+health - Rev 06/19
  • ———PRINCIPAL DISPLAY PANEL - 105 mg Tablet———
    NDC: 72834-105-15 - Rx Only - Fenofibric - Acid Tablets - 105 - mg - 15 tablets - sarras+health - Rev 06/19
  • INGREDIENTS AND APPEARANCE
    Product Information