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These highlights do not include all the information needed to use ROFLUMILAST TABLETS safely and effectively. See full prescribing information for ROFLUMILAST TABLETS. ROFLUMILAST tablets, for oral use Initial U.S. Approval: 2011
Medication labelWhy this: Advisory · dailymed-prescription
Roflumilast tablets is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of Use Roflumilast tablets is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast tablets 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.
- generic_name
- roflumilast
- product_names
- Roflumilast
- ndc
- 67877-480, 67877-730, 67877-480-30, 67877-480-90, 67877-480-05, 67877-480-33, 67877-730-30, 67877-730-90, 67877-730-05, 67877-730-32, 67877-730-93, 67877-730-87
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en