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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. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dose or duration [see Warnings and Precautions (5.1)], and persist over the course of therapy, reserve opioid analgesics, including tapentadol tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA tablets. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
- generic_name
- tapentadol hydrochloride
- product_names
- Tapentadol Hydrochloride
- ndc
- 72205-369, 72205-370, 72205-371, 72205-369-91, 72205-370-91, 72205-371-91
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en