Ultracet

[Tramadol/Acetaminophen]

Indications & Dosage
INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

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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 sensi-tivity to adverse events.

HOW SUPPLIED

ULTRACET (37.5 mg tramadol hydrochloride/ 325 mg acetaminophen) Tablets (light yellow, film-coated capsule-shaped tablet) debossed "O-M" on one side and "650" on the other are available as follows:
20's: NDC 0045 0650 50 (Bottles of 20 tablets) 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 5,336,691 635-11-231-1 © OMP 2001 Issued August 2001 7517200 2