nucynta tapentadol hydrochloride tablet film coated
1 INDICATIONS AND USAGE NUCYNTA (tapentadol) tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. NUCYNTA tablets are an opioid analgesic 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 ) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve NUCYNTA tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia 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 NUCYNTA tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia
depo nf sub, llc
ROUND ORANGE O M 100
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nucynta tapentadol hydrochloride tablet film coated
depo nf sub, llc
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16 HOW SUPPLIED/STORAGE AND HANDLING NUCYNTA Tablets are available in the following strengths and packages. All tablets are round and biconvex-shaped. 50 mg tablets are yellow and debossed with "O-M" on one side and "50" on the other side, and are available in bottles of 100 (NDC 69865-210-02) and hospital unit dose blister packs of 10 (NDC 69865-210-01). 75 mg tablets are yellow-orange and debossed with "O-M" on one side and "75" on the other side, and are available in bottles of 100 (NDC 69865-220-02) and hospital unit dose blister packs of 10 (NDC 69865-220-01). 100 mg tablets are orange and debossed with "O-M" on one side and "100" on the other side, and are available in bottles of 100 (NDC 69865-230-02) and hospital unit dose blister packs of 10 (NDC 69865-230-01). Storage and Handling Store up to 25ºC (77ºF); excursions permitted to 15º - 30ºC (59º - 86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Keep NUCYNTA tablets in a secure place out of reach of children. NUCYNTA tablets that are no longer needed should be destroyed by flushing down the toilet.
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