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FENOPRON™ is indicated for:
Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. FENOPRON™ may be administered with meals or with milk.
For the treatment of mild to moderate pain, the recommended dosage is 200 mg given orally every 4 to 6 hours, as needed.
For the relief of signs and symptoms of rheumatoid arthritis or osteoarthritis the recommended dose is 400 to 600 mg given orally, 3 or 4 times a day. The dose should be tailored to the needs of the patient and may be increased or decreased depending on the severity of the symptoms. Total daily dosage should not exceed 3,200 mg.
The 300 mg capsule is a hard gelatin capsule with an orange opaque cap and a yellow opaque body, imprinted with “R” on the cap and “8” on the body in black ink.
Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed containers.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
To report SUSPECTED ADVERSE REACTIONS, contact Galt Pharmaceuticals, LLC or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.
Full Prescribing Information: DailyMed
