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TRAMADOL HYDROCHLORIDE tramadol hydrochloride 50 MG Oral Tablet

1 INDICATIONS AND USAGE Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. L imitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.1 )] , reserve tramadol hydrochloride for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Have not been tolerated or are not expected to be tolerated. Have not provided adequate analgesia or are not expected to provide adequate analgesia. Tramadol hydrochloride is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate ( 1 ). L i m itations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses ( 5.1 ), reserve tramadol hydrochloride for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Have not been tolerated or are not expected to be tolerated. Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Zydus Pharmaceuticals (USA) Inc.


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4 years ago ROUND WHITE 319 TRAMADOL HYDROCHLORIDE  tramadol hydrochloride 50 MG Oral Tablet

ROUND WHITE 319

4 years ago ROUND WHITE 319 TRAMADOL HYDROCHLORIDE  tramadol hydrochloride 50 MG Oral Tablet

319 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING Tramadol Hydrochloride Tablets, USP 50 mg are white to off-white, round, film-coated tablets debossed with '319' on one side and plain on the other side and are supplied as follows: NDC 68382-319-01 in bottle of 100 tablets NDC 68382-319-05 in bottle of 500 tablets NDC 68382-319-10 in bottle of 1000 tablets NDC 68382-319-77 in cartons of 100 tablets (10 x 10 unit-dose) Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Store tramadol hydrochloride tablets securely and dispose of properly [see Patient Counseling Information ( 17 )] .

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