Naproxen Tablet
FDA Label NDC 68071-4510

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nucare Pharmaceuticals,inc. for the product Naproxen (NDC 68071-4510). 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 how supplied, spl medguide, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

How Supplied

250MG: WHITE TO OFF-WHITE, ROUND SHAPED TABLET WITH 138 DEBOSSED ON ONE SIDE AND SCORED ON OTHER

SIDE.

NDC 68071-4510-6 BOTTLES OF 6

STORE AT 20°-25°C (68°-77°F) EXCURSIONS PERMITTED TO 15°-30°C (59°-86°F) IN WELL-CLOSED CONTAINERS

[SEE USP CONTROLLED ROOM TEMPERATURE]. DISPENSE IN LIGHT-RESISTANT CONTAINERS.

RX ONLY

Spl Medguide

CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISKS OF NAPROXEN AND OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE NAPROXEN TABLETS. USE THE LOWEST EFFECTIVE DOSE FOR THE SHORTEST DURATION CONSISTENT WITH INDIVIDUAL PATIENT TREATMENT GOALS (SEE WARNINGS: GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION).

NAPROXEN 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

NAPROXEN TABLETS ARE ALSO INDICATED:

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

* Please review the disclaimer below.