Albuteroldrug info
NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler
What it is used for
Albuterol Sulfate Inhalation Aerosol is a beta 2 -adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
Prevention of exercise-induced bronchospasm in patients 4 years of age and older.
1.1 Bronchospasm
Albuterol Sulfate Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
1.2 Exercise-Induced
Bronchospasm Albuterol Sulfate Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective October 13, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
The active ingredient of Albuterol Sulfate Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name α 1 -[( tert -butylamino) methyl]-4-hydroxy- m -xylene-α,α’-diol sulfate (2:1)(salt), and has the following chemical structure: The molecular weight of albuterol sulfate is 576.7, and the empirical formula is (C 13 H 21 NO 3 ) 2
H 2 SO 4. Albuterol sulfate is a white to off-white crystalline powder. It is soluble in water and slightly soluble in ethanol. Albuterol sulfate is the official generic name in the United States, and salbutamol sulfate is the World Health Organization recommended generic name. Albuterol Sulfate Inhalation Aerosol is a pressurized metered-dose aerosol unit with a dose counter. Albuterol Sulfate is for oral inhalation only. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1, 1, 1, 2-tetrafluoroethane) and ethanol. Prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face. After priming, each actuation delivers 108 mcg albuterol sulfate, from the actuator mouthpiece (equivalent to 90 mcg of albuterol base). Each canister provides 200 actuations (inhalations). This product does not contain chlorofluorocarbons (CFCs) as the propellant. structure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective October 13, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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