tramadol hydrochloride 50 mg
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 ( 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 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 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) . Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses , reserve tramadol hydrochloride tablets 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. 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 time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
ACI Healthcare USA, Inc.
OVAL WHITE ET50
ET50 OVAL WHITE
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tramadol hydrochloride 50 mg
ACI Healthcare USA, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
TRAMADOL HYDROCHLORIDE Tablets USP, 50 mg are supplied as white film coated capsule shaped unscored tablets debossed with "ET50" on one side and plain on the other side. Bottles of 100 tablets: NDC 71093-119-04 Bottles of 500 tablets: NDC 71093-119-05 Bottles of 1000 tablets: NDC 71093-119-06 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight container as defined in the USP. Store
TRAMADOL HYDROCHLORIDE tablets securely and dispose of properly [see PATIENT COUNSELING INFORMATION (17)] .
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