DOSAGE AND ADMINISTRATION
For the short-term (five days or less) management of acute pain, the recommended dose of tramadol hydrochloride and acetaminophen tablets 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 tramadol hydrochloride and acetaminophen tablets 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
Tramadol hydrochloride and acetaminophen tablets USP, 37.5 mg/325 mg, are light yellow, oblong-shaped, biconvex, film-coated tablets debossed with “I 03" on one side and plain on the other side. They are available as follows:
Bottles of 100 tablets NDC 42571-119-01 Bottles of 500 tablets NDC 42571-119-05 Bottles of 1000 tablets NDC 42571-119-10 Unit Dose Blister Cartons of 80 (8 x 10) tablets NDC 42571-119-23
Dispense in a tight container. Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) [See USP Controlled Room Temperature].
Manufactured by:
Micro Labs Limited
Goa-403 722, INDIA.
Manufactured for:
M
icro Labs USA Inc.
Princeton, NJ08540
Revised: August 2014
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