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  5. Label Information: Naproxen

FDA Label for Naproxen

View Indications, Usage & Precautions

Table of Contents

    1. HOW SUPPLIED
    2. SPL MEDGUIDE
    3. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Naproxen Product Label

The following document was submitted to the FDA by the labeler of this product Nucare Pharmaceuticals,inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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