Naproxen Sodium

Product manufactured by Avpak

Application Nr Approved Date Route Status External Links
ANDA078432 2007-04-25 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Carefully Consider The Potential Benefits And Risks Of Naproxen Sodium Tablets, Usp And Other Treatment Options Before Deciding To Use Naproxen Sodium Tablets, Usp. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings ). Naproxen Suspension Is Recommended For Juvenile Rheumatoid Arthritis In Order To Obtain The Maximum Dosage Flexibility Based On The Patient's Weight. Naproxen As Naproxen Sodium Tablets Are Indicated: • For The Relief Of The Signs And Symptoms Of Rheumatoid Arthritis • For The Relief Of The Signs And Symptoms Of Osteoarthritis • For The Relief Of The Signs And Symptoms Of Ankylosing Spondylitis • For The Relief Of The Signs And Symptoms Of Juvenile Arthritis • For Relief Of The Signs And Symptoms Of Tendonitis • For Relief Of The Signs And Symptoms Of Bursitis • For Relief Of The Signs And Symptoms Of Acute Gout • For The Management Of Pain • For The Management Of Primary Dysmenorrhea

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
2. Povidones POVIDONES Unresolved
3. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Naproxen Sodium NAPROXEN SODIUM ZINC105216

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