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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 and are available as follows:

  100's: NDC 50458-650-60 Bottles of 100 tablets
  HUD 100's: NDC 50458-650-10 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).

Manufactured by:
Janssen Ortho, LLC
Gurabo, Puerto Rico 00778

Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, New Jersey 08560

© Janssen Pharmaceuticals, Inc. 2003
Revised July 2014

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