{"adverse_reactions":["ADVERSE REACTIONS Adverse reactions reported in controlled clinical trials in 960 patients treated for rheumatoid arthritis or osteoarthritis are listed below."],"boxed_warning":["BOXED WARNING Cardiovascular Risk -NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. -Naproxen as Naproxen Tablets, USP is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). Gastrointestinal Risk -NSAIDs may cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration. and perforation of the stomach or intestines, which can be fatal."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Pharmacodynamics - Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties."],"clinical_studies":["CLINICAL STUDIES General Information - Naproxen has been studied in patients with rheumatoid arthritis, osteoarthritis, juvenile arthritis, ankylosing spondylitis, tendonitis and bursitis, and acute gout."],"contraindications":["CONTRAINDICATIONS Naproxen tablets, USP are contraindicated in patients with known hypersensitivity to naproxen, USP."],"description":["Each capsule contains : Naxproxen, ESP ..........500 mg","Dosage and Use : For dosage recommendations and other important prescribing information, read accompanying insert.","DESCRIPTION Naproxen, USP is a proprionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of naproxen tablets, USP and other treatment options before deciding to use naproxen tablets, USP."],"effective_time":"20151015","id":"2b509bf8-1b42-4f47-b51f-6ea1d2d277cf","indications_and_usage":["INDICATIONS AND USAGE Carefully consider the potential benefits and risks of naproxen tablets, USP and other treatments before deciding to sue naproxen tablets, USP."],"openfda":{},"overdosage":["OVERDOSAGE Symptoms and Signs Significant naproxen overdosage may be characterized by lethargy, dizziness, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, disorientation or vomiting."],"package_label_principal_display_panel":["copy of label"],"patient_medication_information":["MEDICATION GUIDE FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) (See the end of this Medication Guide for a list of prescription NSAID medicines.)"],"precautions":["PRECAUTIONS General - Naproxen - containing products such as naproxen tablets, and other naproxen products should not be used concomitantly since they all circulate in the plasma as the naproxin anion ."],"set_id":"cbd9ff1d-ad79-4f44-9db8-4796016bb967","spl_product_data_elements":["Naproxen Naproxen NAPROXEN NAPROXEN CROSCARMELLOSE SODIUM POVIDONES MAGNESIUM STEARATE White IP190;500"],"storage_and_handling":["Store at 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30 C (59 to 86 F)[See USP Controlled Room Temperature] Dispense in well-closed, light-resistant containers as defined in the USP."],"version":"1","warnings":["WARNINGS Cardiovascular Effects - Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and non-selective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal."]}