Tramadol hydrochloride and acetaminophen 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 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.
Apotex Corp.
OVAL YELLOW 37 5 325 apo
37 5 325 apo OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING Tramadol hydrochloride and acetaminophen tablets, USP 37.5 mg/325 mg are yellow, capsule-shaped, film-coated tablets, engraved "37.5-325" on one side, "APO" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-2644-3) Bottles of 90 (NDC 60505-2644-9) Bottles of 100 (NDC 60505-2644-1) Bottles of 500 (NDC 60505-2644-5) Bottles of 1,000 (NDC 60505-2644-8) Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Store tramadol hydrochloride and acetaminophen tablets securely and dispose of properly [see Patient Counseling Information ( 17 )].
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