24 HR Naproxen 500 MG Extended Release Oral Tablet Naprelan
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of NAPRELAN ® Tablets and other treatment options before deciding to use NAPRELAN ® Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). NAPRELAN ® Tablets are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis and acute gout. It is also indicated in the relief of mild to moderate pain and the treatment of primary dysmenorrhea.
Shionogi Inc.
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HOW SUPPLIED NAPRELAN ® (naproxen sodium) Controlled-Release Tablets are available as follows: NAPRELAN ® 375: white, capsule-shaped tablet with “N” on one side and “375” on the reverse; in bottles of 100; NDC 59630-375-10. Each tablet contains 412.5 mg naproxen sodium equivalent to 375 mg naproxen. NAPRELAN ® 500: white, capsule-shaped tablet with “N” on one side and “500” on the reverse; in bottles of 75; NDC 59630-850-75. Each tablet contains 550 mg naproxen sodium equivalent to 500 mg naproxen. NAPRELAN ® 750: white-capsule-shaped tablet with “N” on one side and “750” on the reverse; in bottles of 30; 59630-777-03. Each tablet contains 825 mg naproxen sodium equivalent to 750 mg naproxen. Rx only US Patent 5,637,320 Store at controlled room temperature, 20° to 25° C (68° to 77° F). PHARMACIST: Dispense in a well-closed container. _____________________________________________________ * Registered Trademark of Alkermes Pharma Ireland Ltd. ** Registered Trademark of Alkermes Pharma Ireland Ltd. *** Naprosyn ® is a registered trademark of Syntex Pharmaceuticals International Limited Manufactured for: Shionogi Inc., Florham Park, NJ 07932 Manufactured by: Alkermes Pharma Ireland Limited, Athlone, Ireland NAP-PI -2 Rev 03/2013
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