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These highlights do not include all the information needed to use SYMBICORT safely and effectively. See full prescribing information for SYMBICORT. SYMBICORT ®(budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006
Medication labelWhy this: Advisory · dailymed-prescription
SYMBICORT is indicated for the treatment of asthma in patients 6 years of age and older. SYMBICORT should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA). Important Limitations of Use: SYMBICORT is NOT indicated for the relief of acute bronchospasm. SYMBICORT 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. SYMBICORT 160/4.5 is also indicated to reduce exacerbations of COPD. SYMBICORT 160/4.5 is the only strength indicated for the treatment of COPD. Important Limitations of Use: SYMBICORT is NOT indicated for the relief of acute bronchospasm.
- generic_name
- budesonide and formoterol fumarate dihydrate
- product_names
- Budesonide and Formoterol Fumarate Dihydrate
- ndc
- 85766-184, 0186-0372, 85766-184-28
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en