Tramadol Hydrochloride and Acetaminophen Acetaminophen 325 MG tramadol hydrochloride 37.5 MG Oral Tablet
1 INDICATIONS AND USAGE Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1) ] , reserve tramadol hydrochloride and acetaminophen 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 and acetaminophen tablets are a combination of tramadol hydrochloride, an opioid agonist, and acetaminophen, and is indicated for the management of acute pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve tramadol hydrochloride and acetaminophen 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 of New York, LLC
OVAL BROWN AN 617
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16 HOW SUPPLIED/STORAGE AND HANDLING Tramadol hydrochloride and acetaminophen tablets USP, 37.5 mg/ 325 mg, are beige colored, film-coated, biconvex capsule shaped tablets with “AN 617” debossed on one side and plain on the other side. Bottle of 30 Tablets: NDC 65162-617-03 Bottle of 100 Tablets: NDC 65162-617-10 Bottle of 500 Tablets: NDC 65162-617-50 Bottle of 1000 tablets: NDC 65162-617-11 Blister packs: NDC 65162-617-60 (Packages of 100 unit doses, 10 cards of 10 tablets each) 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]. Dispense in a tight container as defined in the USP. Store tramadol hydrochloride and acetaminophen tablets securely and dispose of properly [see Patient Counseling Information (17) ].
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