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| Ordering Information |
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| HOW SUPPLIED |
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| AccuNeb® (albuterol sulfate) Inhalation Solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in 2 different strengths, 0.63 mg and 1.25 mg, of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of AccuNeb® (albuterol sulfate) Inhalation Solution is available in a shelf carton containing multiple foil pouches. |
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AccuNeb® (albuterol sulfate) Inhalation Solution, 0.63 mg (potency expressed as albuterol) contains 0.75 mg albuterol sulfate per
3 mL in unit-dose vials and is available in the following packaging configuration:
NDC 49502-692-03 5 foil pouches, each containing 5 vials, total 25 vials per carton. |
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AccuNeb® (albuterol sulfate) Inhalation Solution, 1.25 mg (potency expressed as albuterol) contains 1.50 mg albuterol sulfate per
3 mL in unit-dose vials and is available in the following packaging configuration:
NDC 49502-693-03 5 foil pouches, each containing 5 vials, total 25 vials per carton. |
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| AccuNeb® (albuterol sulfate) Inhalation Solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease). |
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| Important Safety Information |
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| In a clinical trial with AccuNeb® Inhalation Solution 0.63 mg, AccuNeb® Inhalation Solution 1.25 mg, and placebo, the most commonly reported adverse events were asthma exacerbations (11.1%, 13%, 8.5%), otitis media (0.9%, 4.3%, 0%), allergic reaction (3.4%, 0.9%, 1.7%), gastroenteritis (3.4%, 0.9%, 0.9%), and flu syndrome (2.6%, 2.6%, 1.7%). |
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| Like other beta-adrenergic agonists, AccuNeb® Inhalation Solution can produce paradoxical bronchospasm, which may be life-threatening. AccuNeb® Inhalation Solution should be used with caution in patients with cardiovascular disorders and patients being treated with epinephrine, oral sympathomimetics, beta-blockers, MAOIs, or tricyclic antidepressants. |
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| Please see Patient Prescribing Information. |
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