DOSAGE AND ADMINISTRATION
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.
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HOW SUPPLIED
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). |
OMP DIVISION
ORTHO-McNEIL
PHARMACEUTICAL, INC.
Raritan, New Jersey 08869
U.S. Patent 5,336,691
7517201
© OMP 2003
Issued April 2004
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