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Tramadol and Acetaminophen (Tramadol Hydrochloride / Acetaminophen) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Tramadol hydrochloride and acetaminophen tablets USP are 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 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.

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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