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 opiod analgesic and for which alternative treatments are inadequate. L imitations of Use Tramadol hydrochloride and acetaminophen tablets are indicated for short-tern 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 ) L i mitations of Use ( 1 ) Tramadol hydrochloride and acetaminophen tabletsare 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.
Par Pharmaceutical Inc.
OVAL ORANGE Kali 083
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16 HOW SUPPLIED Tramadol Hydrochloride and Acetaminophen Tablets 37.5 mg/325 mg, (orange, film-coated capsule-shaped tablets) debossed “083” on one side and “KALI” on the other side are available as follows: Bottles of 100 tablets NDC 49884-946-01 Bottles of 500 tablets NDC 49884-946-05 Dispense in a tight container. Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F).
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