The following Structured Product Label (SPL) was submitted to the FDA by Central Packaging for the product Naproxen (NDC 80175-0436). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Naproxen Tablets are indicated for:
the relief of the signs and symptoms of:
rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
tendonitis
bursitis
acute gout
the management of:
pain
primary dysmenorrhea
* Please review the disclaimer below.
