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Hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen sodium, aspirin, NSAIDs, paracetamol or to any component in the product.
Patients who are diagnosed with asthma, urticaria, or other allergic reactions after taking aspirin or other NSAIDs (see Precautions).
Patients with active peptic/duodenal/GI ulcers, bleeding or perforation related to previous NSAID therapy.
Patients with active recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding) unrelated to previous NSAID therapy.
Patients with cerebrovascular bleeding or other bleeding disorders.
Patients with inflammatory bowel disease, chronic dyspepsia, congestive gastritis, or atrophic gastritis.
Patients with known hyperkalemia.
Patients with severe uncontrolled cardiac failure (see Precautions).
Patients with severe liver impairment or severe active liver disease.
Patients with severe renal impairment (creatinine clearance <30 mL/min) or deteriorating renal disease.
During the last trimester of pregnancy.
Breastfeeding women.
In the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
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