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. Limitations 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 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. 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) Limitations of Use (1) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses ( 5.1 ), 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.
Amneal Pharmaceuticals LLC
ROUND WHITE AN 627
AN 627 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
TRAMADOL HYDROCHLORIDE Tablets USP, 50 mg are supplied as unscored, white, round film-coated tablets debossed “AN” over “627” on one side and plain on the other side. They are supplied as follows: Bottles of 10: NDC 65162-627-01 Bottles of 100: NDC 65162-627-10 Bottles of 500: NDC 65162-627-50 Bottles of 1000: NDC 65162-627-11 Dispense in a tight container. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store
TRAMADOL HYDROCHLORIDE tablets securely and dispose of properly [see Patient Counseling Information (17)] .
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