tramadol hydrochloride 100 mg
1 INDICATIONS AND USAGE Tramadol hydrochloride tablets, USP 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 is 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.
trupharma llc
OVAL WHITE 019
019 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
TRAMADOL HYDROCHLORIDE Tablets USP 50 mg are white to off white, capsule-shaped film coated tablet debossed with "018"on one side and plain on the otherside. Bottles of 100 tablets……. NDC 52817-195-10 Bottles of 500 tablets…..... NDC 52817-195-50 Bottles of 1,000 tablets…...NDC 52817-195-00
TRAMADOL HYDROCHLORIDE Tablets USP 100 mg are white to off white, capsule-shaped film coated tablet debossed with "019"on one side and scored on the otherside. Bottles of 100 tablets……. NDC 52817-196-10 Bottles of 500 tablets…..... NDC 52817-196-50 Bottles of 1,000 tablets…... NDC 52817-196-00 Dispense in a tight container. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].
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