Albuterol Sulfate Hfa

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• For oral inhalation only Treatment or prevention of bronchospasm in
• adults and
• children 4 years of age and older:
• 2 inhalations every 4 to 6 hours.
• In some patients, one inhalation every 4 hours may be sufficient.
• ( 2.1 ) Prevention of exercise-induced bronchospasm in
• adults and
• children 4 years of age and older:
• 2 inhalations 15 to 30 minutes before exercise.
• ( 2.2 ) Priming information:
• Prime Albuterol Sulfate HFA before using for the first time, or when the inhaler has not been used for more than 2 weeks.
• To prime Albuterol Sulfate HFA, release 3 sprays into the air away from the face.
• Shake well before each spray.
• ( 2.3 ) Cleaning information:
• At least once a week, wash the actuator with warm water, shake off excess, and air dry thoroughly.
• ( 2.3 ) Albuterol Sulfate HFA inhaler should be discarded when the dose counter displays 0 or after the expiration date on the product, whichever comes first.
• ( 2.3 )
• 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 inhalations repeated every 4 to 6 hours.
• More frequent administration or a larger number of inhalations is not recommended.
• In some patients, one inhalation every 4 hours may be sufficient.
• Exercise-Induced Bronchospasm The usual dosage for
• adults and
• children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.
• 2.3 Administration Information Administer Albuterol Sulfate HFA by oral inhalation only.
• Shake well before each spray.
• To maintain proper use of this product and to prevent medication build-up and blockage, it is important to follow the cleaning directions carefully.
• Priming:
• 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.
• Cleaning:
• As with all HFA-containing albuterol inhalers, to maintain proper use of this product and to prevent medication build-up and blockage, it is important to clean the plastic mouthpiece regularly.
• The inhaler may cease to deliver medication if the plastic actuator mouthpiece is not properly cleaned and dried.
• To clean:
• Wash the plastic mouthpiece with warm running water for 30 seconds, shake off excess water, and air dry thoroughly at least once a week .
• If the patient has more than one Albuterol Sulfate HFA inhaler, the patient should wash each one separately to prevent attaching the wrong canister to the wrong plastic actuator.
• In this way, the patient can be sure to always know the correct number of remaining doses.
• Never attach a canister of medication from any other inhaler to the Albuterol Sulfate HFA actuator and never attach the Albuterol Sulfate HFA canister to an actuator from any other inhaler.
• If the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage.
• If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, spray twice into the air away from face, and take the prescribed dose.
• After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly. [see FDA-Approved Patient Labeling (17.9) ] .
• Dose Counter: Albuterol Sulfate HFA has a dose counter attached to the actuator.
• When the patient receives the inhaler, a black dot will appear in the viewing window until it has been primed 3 times, at which point the number 200 will be displayed.
• The dose counter will count down each time a spray is released.
• When the dose counter reaches 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill of medication or consult their physician for a prescription refill.
• When the dose counter reaches 0, the background will change to solid red.
• Albuterol Sulfate HFA inhaler should be discarded when the dose counter displays 0 or after the expiration date on the product, whichever comes first.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety and effectiveness of Albuterol Sulfate HFA Inhalation Aerosol for the treatment or prevention of bronchospasm in children 12 years of age and older with reversible obstructive airway disease is based on one 6-week clinical trial in 116 patients 12 years of age and older with asthma comparing doses of 180 mcg four times daily with placebo, and one single-dose crossover study comparing doses of 90, 180, and 270 mcg with placebo in 58 patients [see Clinical Studies (14.1) ] .
• The safety and effectiveness of Albuterol Sulfate HFA Inhalation Aerosol for treatment of exercise-induced bronchospasm in children 12 years of age and older is based on one single-dose crossover study in 24
• adults and adolescents with exercise-induced bronchospasm comparing doses of 180 mcg with placebo [see Clinical Studies (14.2) ].
• The safety of Albuterol Sulfate HFA Inhalation Aerosol in
• children 4 to 11 years of age is based on one 3-week clinical trial in 50 patients 4 to 11 years of age with asthma using the same formulation of albuterol as in Albuterol Sulfate HFA Inhalation Aerosol comparing doses of 180 mcg four times daily with placebo.
• The effectiveness of Albuterol Sulfate HFA Inhalation Aerosol in
• children 4 to 11 years of age is extrapolated from clinical trials in patients 12 years of age and older with asthma and exercise-induced bronchospasm, based on data from a single-dose study comparing the bronchodilatory effect of Albuterol Sulfate HFA 90 mcg and 180 mcg with placebo in 55 patients with asthma and a 3-week clinical trial using the same formulation of albuterol as in Albuterol Sulfate HFA Inhalation Aerosol in 95 asthmatic
• children 4 to 11 years of age comparing a dose of 180 mcg albuterol four times daily with placebo [see Clinical Studies (14.1) ].
• The safety and effectiveness of Albuterol Sulfate HFA Inhalation Aerosol in pediatric patients below the age of 4 years have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Clinical studies of Albuterol Sulfate HFA Inhalation Aerosol did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
• Other reported clinical experience has not identified differences in responses between elderly and younger patients.
• In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Warnings and Precautions (5.4 , 5.7) ] .
• All beta 2 -adrenergic agonists, including albuterol, are known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function.
• Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Quoted from the official label, section “Geriatric Use”.

Side effects

• Use of Albuterol Sulfate HFA may be associated with the following:
• Paradoxical bronchospasm [see Warnings and Precautions (5.1) ] Cardiovascular Effects [see Warnings and Precautions (5.4) ] Immediate hypersensitivity reactions [see Warnings and Precautions (5.6) ] Hypokalemia [see Warnings and Precautions (5.8) ] Most common adverse reactions (≥3.0% and >placebo) are headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis.
• ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Respiratory, LLC at 1-888-482-9522 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience A total of 1090 subjects were treated with Albuterol Sulfate HFA Inhalation Aerosol, or with the same formulation of albuterol as in Albuterol Sulfate HFA Inhalation Aerosol, during the worldwide clinical development program.
• Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• Adult and Adolescents 12 Years of Age and Older:
• The adverse reaction information presented in the table below concerning Albuterol Sulfate HFA Inhalation Aerosol is derived from a 6-week, blinded study which compared Albuterol Sulfate HFA Inhalation Aerosol (180 mcg four times daily) with a double-blinded matched placebo HFA-Inhalation Aerosol and an evaluator-blinded marketed active comparator HFA-134a albuterol inhaler in 172 asthmatic patients 12 to 76 years of age.
• The table lists the incidence of all adverse events (whether considered by the investigator drug related or unrelated to drug) from this study which occurred at a rate of 3% or greater in the Albuterol Sulfate HFA Inhalation Aerosol treatment group and more frequently in the Albuterol Sulfate HFA Inhalation Aerosol treatment group than in the matched placebo group.
• Overall, the incidence and nature of the adverse events reported for Albuterol Sulfate HFA Inhalation Aerosol and the marketed active comparator HFA-134a albuterol inhaler were comparable.
• Adverse Experience Incidences (% of Patients) in a Six-Week Clinical Trial This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of at least 3.0% in the Albuterol Sulfate HFA Inhalation Aerosol group and more frequently in the Albuterol Sulfate HFA Inhalation Aerosol group than in the placebo HFA Inhalation Aerosol group.
• Body System/ Adverse Event (as Preferred Term) Albuterol Sulfate HFA Inhalation Aerosol (N = 58) Marketed active comparator HFA-134a albuterol inhaler (N = 56) Matched Placebo HFA-134a Inhalation Aerosol (N = 58) Body as a Whole Headache 7 5 2 Cardiovascular Tachycardia 3 2 0 Musculoskeletal Pain 3 0 0 Nervous System Dizziness 3 0 0 Respiratory System Pharyngitis 14 7 9 Rhinitis 5 4 2 Adverse events reported by less than 3% of the patients receiving Albuterol Sulfate HFA Inhalation Aerosol but by a greater proportion of Albuterol Sulfate HFA Inhalation Aerosol patients than the matched placebo patients, which have the potential to be related to Albuterol Sulfate HFA Inhalation Aerosol, included chest pain, infection, diarrhea, glossitis, accidental injury (nervous system), anxiety, dyspnea, ear disorder, ear pain, and urinary tract infection.
• In small cumulative dose studies, tremor, nervousness, and headache were the most frequently occurring adverse events.
• Pediatric Patients 4 to 11 Years of Age:
• Adverse events reported in a 3-week pediatric clinical trial comparing the same formulation of albuterol as in Albuterol Sulfate HFA Inhalation Aerosol (180 mcg albuterol four times daily) to a matching placebo HFA inhalation aerosol occurred at a low incidence rate (no greater than 2% in the active treatment group) and were similar to those seen in adult and adolescent trials.
• 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of Albuterol Sulfate HFA.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Reports have included rare cases of aggravated bronchospasm, lack of efficacy, asthma exacerbation (reported fatal in one case), muscle cramps, and various oropharyngeal side-effects such as throat irritation, altered taste, glossitis, tongue ulceration, and gagging.
• The following adverse events have been observed in postapproval use of inhaled albuterol:
• urticaria, angioedema, rash, bronchospasm, hoarseness, oropharyngeal edema, and arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles).
• In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as:
• angina, hypertension or hypotension, palpitations, central nervous system stimulation, insomnia, headache, nervousness, tremor, muscle cramps, drying or irritation of the oropharynx, hypokalemia, hyperglycemia, and metabolic acidosis.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• See FDA-Approved Patient Labeling (17.9) Patients should be given the following information:
• 17.1 Frequency of Use The action of Albuterol Sulfate HFA Inhalation Aerosol should last for 4 to 6 hours.
• Do not use Albuterol Sulfate HFA Inhalation Aerosol more frequently than recommended.
• Instruct patients to not increase the dose or frequency of doses of Albuterol Sulfate HFA Inhalation Aerosol without consulting the physician.
• If patients find that treatment with Albuterol Sulfate HFA Inhalation Aerosol becomes less effective for symptomatic relief, symptoms become worse, and/or they need to use the product more frequently than usual, they should seek medical attention immediately.
• 17.2 Priming and Cleaning Priming :
• Priming is essential to ensure appropriate albuterol content in each actuation.
• Instruct patients to 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.
• Cleaning:
• To ensure proper dosing and prevent actuator orifice blockage, instruct patients to wash the red plastic actuator mouthpiece and dry thoroughly at least once a week.
• Instruct patients that if they have more than one Albuterol Sulfate HFA inhaler, they should wash each one at separate times to prevent attaching the wrong canister to the wrong plastic actuator.
• In this way, they can be sure they will always know the correct number of remaining doses.
• Patients should be instructed to never attach a canister of medicine from any other inhaler to the Albuterol Sulfate HFA actuator and never attach the Albuterol Sulfate HFA canister to an actuator from any other inhaler.
• Patients should not remove the canister from the actuator except during cleaning because reattachment may release a dose into the air and the dose counter will count down each time a spray is released.
• Detailed cleaning instructions are included in the illustrated Information for the Patient leaflet.
• 17.3 Dose Counter Patients should be informed that Albuterol Sulfate HFA has a dose counter attached to the actuator.
• When the patient receives the inhaler, a black dot will appear in the viewing window until it has been primed 3 times, at which point the number 200 will be displayed.
• The dose counter will count down each time a spray is released.
• The dose-counter window displays the number of sprays left in the inhaler in units of two (e.g., 200, 198, 196, etc).
• When the counter displays 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill of medication or consult their physician for a prescription refill.
• When the dose counter reaches 0, the background will change to solid red.
• Patients should be informed to discard Albuterol Sulfate HFA inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first.
• 17.4 Paradoxical Bronchospasm Inform patients that Albuterol Sulfate HFA Inhalation Aerosol can produce paradoxical bronchospasm.
• Instruct patients to discontinue Albuterol Sulfate HFA Inhalation Aerosol if paradoxical bronchospasm occurs.
• 17.5 Concomitant Drug Use While patients are taking Albuterol Sulfate HFA Inhalation Aerosol, other inhaled drugs and asthma medications should be taken only as directed by a physician.
• 17.6 Common Adverse Events Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, or nervousness.
• 17.7 Pregnancy Patients who are pregnant or nursing should contact their physician about the use of Albuterol Sulfate HFA Inhalation Aerosol.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy [see Use in Specific Populations ( 8.1 )] .
• 17.8 General Information on Use Effective and safe use of Albuterol Sulfate HFA Inhalation Aerosol includes an understanding of the way that it should be administered.
• Shake well before each spray.
• Use Albuterol Sulfate HFA Inhalation Aerosol only with the actuator supplied with the product.
• Discard the Albuterol Sulfate HFA inhaler when the dose counter displays 0 or after the expiration date on the product, whichever comes first.
• Never immerse the canister in water to determine how full the canister is ("float test").
• In general, the technique for administering Albuterol Sulfate HFA Inhalation Aerosol to children is similar to that for
• adults.
• Children should use Albuterol Sulfate HFA Inhalation Aerosol under adult supervision, as instructed by the patient's physician .
• 17.9 FDA-Approved Patient Labeling See tear-off illustrated Information for the Patient leaflet.
• Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS & STRENGTHS Albuterol Sulfate HFA is an inhalation aerosol.
• Albuterol Sulfate HFA is supplied as an 8.5 g/200 actuations pressurized aluminum canister with a red plastic actuator with a dose counter and white dust cap each in boxes of one.
• Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).
• Inhalation Aerosol:
• Each actuation delivers 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).
• Supplied in 8.5-g canister containing 200 actuations.
• ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Albuterol Sulfate HFA Inhalation Aerosol is supplied as a pressurized aluminum canister with a red plastic actuator with a dose counter and white dust cap each in boxes of one.
• Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 76420-088-01 relabeled from NDC 0093-3174-31).
• Each actuation delivers 120 mcg of albuterol sulfate from the canister valve and 108 mcg of albuterol sulfate from the actuator mouthpiece (equivalent to 90 mcg of albuterol base).
• SHAKE WELL BEFORE USE.
• Store between 15° and 25°C (59° and 77°F).
• Contents under pressure.
• Do not puncture or incinerate.
• Protect from freezing temperatures and prolonged exposure to direct sunlight.
• Exposure to temperatures above 120°F may cause bursting.
• For best results, canister should be at room temperature before use.
• Avoid spraying in eyes.
• Keep out of reach of children.
• See FDA-Approved Patient Labeling (17.9) for priming and cleaning instructions.
• The red actuator supplied with Albuterol Sulfate HFA Inhalation Aerosol should not be used with the canister from any other inhalation aerosol products.
• The Albuterol Sulfate HFA Inhalation Aerosol canister should not be used with the actuator from any other inhalation aerosol products.
• Albuterol Sulfate HFA inhaler has a dose counter attached to the actuator.
• Patients should never try to alter the numbers for the dose counter or tamper with the pin mechanism inside the actuator.
• Discard the Albuterol Sulfate HFA inhaler when the counter displays 0 or after the expiration date on the product, whichever comes first.
• The labeled amount of medication in each actuation cannot be assured after the counter displays 0, even though the canister is not completely empty and will continue to operate.
• Never immerse the canister into water to determine how full the canister is ("float test").
• Albuterol Sulfate HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

Quoted from the official label, section “How Supplied”.

What is in it

• The active ingredient of Albuterol Sulfate HFA 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 HFA Inhalation Aerosol is a pressurized metered-dose aerosol unit with a dose counter. Albuterol Sulfate HFA 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. chemical structure

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

7 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

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