tramadol hydrochloride tablet film coated
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. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions ( 5.1 )] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: 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 tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. Tramadol hydrochloride tablets are 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 ). Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration ( 5.1 ), reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated or are not expected to be tolerated ( 1 ) Have not provided adequate analgesia or are not expected to provide adequate analgesia ( 1 ) Tramadol hydrochloride tablets should not be used for an extended period of times unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
unichem pharmaceuticals (usa), inc.
OVAL YELLOW 355 U
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16 HOW SUPPLIED/STORAGE AND HANDLING
TRAMADOL HYDROCHLORIDE tablets USP, 50 mg are Pale yellow colored, capsule shaped biconvex, film coated tablet debossed with "355" on one side of break line and "U" on the other side of breakline on one side and plain on other side. Bottles of 100: NDC 29300-355-01 Bottles of 500: NDC 29300-355-05 Bottles of 1,000: NDC 29300-355-10 Store at 20 o to 25 o C (68° to 77°F) [see USP Controlled Room Temperature]. Store
TRAMADOL HYDROCHLORIDE tablets securely and dispose of properly [see Patient Counseling Information ( 17 )]
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