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These highlights do not include all the information needed to use TAPENTADOL TABLETS safely and effectively. See full prescribing information for TAPENTADOL TABLETS. Tapentadol tablets for oral use C-II Initial U.S. Approval: 2008
Medication labelWhy this: Advisory · dailymed-prescription
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 and pediatric patients aged 6 years and older with a body weight of at least 40kg. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dose or duration [see Warnings and Precautions (5.1)], reserve tapentadol 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 Tapentadol tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
- generic_name
- tapentadol hydrochloride
- product_names
- Tapentadol Hydrochloride
- ndc
- 0054-0942, 0054-0942-25, 0054-0943, 0054-0943-25, 0054-0945, 0054-0945-25
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en