Medication safety

Naproxen

Generic name: NAPROXEN

Manufacturer: A-S Medication Solutions

Active recall

CGMP Deviations

Class IIInitiated: Mar 13, 2025

Chemical contamination; presence of lead and lithium above specification

Class IIInitiated: Apr 20, 2026

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Class IIInitiated: Nov 7, 2023

When to use

1 INDICATIONS AND USAGE Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets and naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: • tendonitis • bursitis • acute gout the management…

Dosage and administration

2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. ( 2.1 ) Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis Naproxen tablets 250 mg (one-half tablet) 500 mg twice daily Naproxen sodium tablets 275 mg (one-half tablet) 550 mg twice daily The dose may be adjusted up or down depending on the clinical…

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Drug information is sourced from openFDA and is for educational purposes. It does not replace medical advice from a licensed professional. Always consult your healthcare provider before taking any medication.