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 tablets are 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.
Virtus Pharmaceuticals
OVAL WHITE 101 OUYI
101 OUYI OVAL WHITE
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tramadol hydrochloride 50 MG Oral Tablet
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tramadol hydrochloride 50 MG Oral Tablet
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tramadol hydrochloride 50 MG Oral Tablet
Virtus Pharmaceuticals LLC
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16 HOW SUPPLIED/STORAGE AND HANDLING Bottles of 100 tablets with child-resistant closure: NDC 69543-136-10 Bottles of 500 tablets: NDC 69543-136-50 Bottles of 1000 tablets: NDC 69543-136-11 Dispense in a tight container. Keep out of reach of children. 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]. Store tramadol hydrochloride tablets securely and dispose of properly [see Patient Counseling Information ( 17 )] .
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