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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 useInitial U.S. Approval: 2011
Medication labelWhy this: Advisory · dailymed-prescription
Roflumilast tablets are 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 is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast tablet 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
- 68382-624, 68382-969, 68382-969-06, 68382-969-16, 68382-624-30, 68382-624-83, 68382-624-31
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en