Ultracet (Tramadol Hydrochloride / Acetaminophen) - Indications and Dosage

INDICATIONS AND USAGE

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

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.

HOW SUPPLIED

ULTRACET^® (tramadol hydrochloride/acetaminophen) Tablets with tramadol 37.5 mg and acetaminophen 325 mg 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
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).