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

Combunox tablet is indicated for the short term (no more than 7 days) management of acute, moderate to severe pain.

Carefully consider the potential benefits and risks of Combunox and other treatment options before deciding to use Combunox. 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 Combunox, the dose and frequency should be adjusted to suit an individual patient's needs.”

For the management of acute moderate to severe pain, the recommended dose of Combunox is one tablet given orally.

Dosage should not exceed 4 tablets in a 24-hour period and should not exceed 7 days.

Combunox are capsule shaped, white to off-white, film-coated tablets with “F” bisect “P” on one side and “5400” on the other side.

Bottles of 100-NDC #0456-5200-01

Storage

Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF). A Schedule CII Narcotic

Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, Inc. St. Louis, MO 63045 USA Rev 02/07 (c) 2007 Forest Laboratories, Inc. FDA Rev date: 6/20/2007

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