tramadol hydrochloride 37.5 mg acetaminophen 325 mg
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 are 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.
Mylan Pharmaceuticals Inc.
ROUND YELLOW M P T
M P T ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING Tramadol Hydrochloride and Acetaminophen Tablets, USP are available containing tramadol hydrochloride USP, 37.5 mg and acetaminophen USP, 325 mg. The 37.5 mg/325 mg tablets are yellow, film-coated, round, unscored tablets debossed with P/T on one side of the tablet and M on the other side. They are available as follows: NDC 0378-8088-01 bottles of 100 tablets NDC 0378-8088-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store tramadol hydrochloride and acetaminophen tablets securely and dispose of properly [see Patient Counseling Information (17) ] . PHARMACIST: Dispense a Medication Guide with each prescription.
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