Label: ALBUTEROL SULFATE aerosol, metered

  • NDC Code(s): 68180-963-01
  • Packager: Lupin Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 23, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ALBUTEROL SULFATE INHALATION AEROSOL safely and effectively. See full prescribing information for ALBUTEROL SULFATE INHALATION ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    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 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Bronchospasm - For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children 4 years and older is two ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Albuterol sulfate inhalation aerosol is an inhalation aerosol. Albuterol sulfate inhalation aerosol is supplied as an 8.5 g/200 actuations pressurized aluminum canister with a blue plastic ...
  • 4 CONTRAINDICATIONS
    Albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other albuterol sulfate inhalation aerosol components. Rare cases of ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Paradoxical Bronchospasm - Albuterol sulfate inhalation aerosol can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, albuterol sulfate ...
  • 6 ADVERSE REACTIONS
    Use of albuterol sulfate may be associated with the following:    •   Paradoxical bronchospasm [see WARNINGS AND PRECAUTIONS (5.1)]    •   Cardiovascular Effects [see WARNINGS AND PRECAUTIONS ...
  • 7 DRUG INTERACTIONS
    Other short-acting sympathomimetic aerosol bronchodilators should not be used concomitantly with albuterol sulfate inhalation aerosol. If additional adrenergic drugs are to be administered by ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy. For more ...
  • 10 OVERDOSAGE
    The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, e.g., seizures ...
  • 11 DESCRIPTION
    The active ingredient of albuterol sulfate inhalation aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name α1-[(tert-butylamino ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Albuterol sulfate is a beta2-adrenergic agonist. The pharmacologic effects of albuterol sulfate are attributable to activation of beta2-adrenergic receptors on airway ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In a 2-year study in Sprague-Dawley rats, albuterol sulfate caused a dose-related increase in the incidence of benign leiomyomas of ...
  • 14 CLINICAL STUDIES
    14.1 Bronchospasm Associated with Asthma - Adult and Adolescent Patients 12 Years of Age and Older - In a 6-week, randomized, double-blind, placebo-controlled trial, albuterol sulfate (58 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Albuterol sulfate inhalation aerosol is supplied as a pressurized aluminum canister with a blue plastic actuator with a dose indicator and green dust cap each in boxes of one. Each canister ...
  • 17 PATIENT COUNSELING INFORMATION
    See FDA-Approved Patient Labeling (17.9) Patients should be given the following information: 17.1 Frequency of Use - The action of albuterol sulfate inhalation aerosol should last for 4 to 6 ...
  • PATIENT PACKAGE INSERT
    Patient Information - Albuterol Sulfate (al bue' ter ol) (sul' fate) Inhalation Aerosol - Read this Patient Information before you start using albuterol sulfate inhalation aerosol and each time ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - Inhaler Canister Label - NDC 68180-963-01 - Albuterol Sulfate Inhalation Aerosol - 90 mcg per actuation - For Oral Inhalation with Enclosed Actuator Only - Rx only - 200 ...
  • INGREDIENTS AND APPEARANCE
    Product Information