Carefully consider the potential benefits and risks of Nalfon and other treatment options before deciding to use Nalfon. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS) .

Nalfon is indicated:

• For relief of mild to moderate pain in adults.
• For relief of the signs and symptoms of rheumatoid arthritis.
• For relief of the signs and symptoms of osteoarthritis.

Carefully consider the potential benefits and risks of Nalfon and other treatment options before deciding to use Nalfon. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with Nalfon, the dose and frequency should be adjusted to suit an individual patient's needs.

Analgesia

For the treatment of mild to moderate pain, the recommended dosage is 200 mg given orally every 4 to 6 hours, as needed.

Rheumatoid Arthritis and Osteoarthritis

For the relief of rheumatoid arthritis or osteoarthritis the recommended dose is 300 to 600 mg given orally, 3 or 4 times a day. The dose should be tailored to the needs of the patient and may be increased or decreased depending on the severity of the symptoms. Dosage adjustments may be made after initiation of drug therapy or during exacerbations of the disease. Total daily dosage should not exceed 3,200 mg.

Nalfon may be administered with meals or with milk. Although the total amount absorbed is not affected, peak blood levels are delayed and diminished.

Patients with rheumatoid arthritis generally seem to require larger doses of Nalfon than do those with osteoarthritis. The smallest dose that yields acceptable control should be employed.

Although improvement may be seen in a few days in many patients, an additional 2 to 3 weeks may be required to gauge the full benefits of therapy.

Nalfon® (fenoprofen calcium capsules, USP) are available in:

The 200 mg* capsule is opaque yellow No. 97 cap and opaque white body,

imprinted with "RX681" on the cap and body.

NDC 0884-6S00-10 Bottles of 100

* Equivalent to fenoprofen.

Preserve in well-closed containers.

Store at 20° - 25° C (68° - 77° F). (See USP Controlled Room Temperature).

ATTENTION DISPENSER: Accompanying Medication Guide must be dispensed with this product.

Manufactured for: Pedinol Pharmacal Inc. Farmingdale, NY 11735 USA. By: Ohm Laboratories, Inc. North Brunswick, NJ 08902 USA. February 2007. FDA Rev date: 8/7/2007

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