ULTRACET® is indicated for the short-term (five days or less) management of acute pain.

For the short-term (five days or less) management of acute pain, the recommended dose of ULTRACET® is 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day.

Individualization of Dose

In patients with creatinine clearances of less than 30 mL/min, it is recommended that the dosing interval of ULTRACET® be increased not to exceed 2 tablets every 12 hours. Dose selection for an elderly patient should be cautious, in view of the potential for greater sensitivity to adverse events.

ULTRACET® (tramadol hydrochloride/acetaminophen) Tablets are light yellow, coated, capsule-shaped tablets imprinted “O-M” on one side and “650” on the other are available as follows:

100's: NDC 0045 0650 60 (Bottles of 100 tablets)
500's: NDC 0045 0650 70 (Bottles of 500 tablets)
HUD 100's: NDC 0045 0650 10 (Packages of 100 unit doses in blister packs, 10 cards of 10 tablets each)

Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).

ORTHO-McNEIL., OMP DIVISION., ORTHO-McNEIL PHARMACEUTICAL, INC., Raritan, New Jersey 08869
U.S. Patent 5,336,691
Issued April 2004
FDA rev date: 4/16/2004

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