Product Elements:
Albuterol sulfate albuterol sulfate norflurane alcohol oleic acid albuterol sulfate albuterol
Drug Interactions:
Drug interactions beta-blockers: beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as albuterol sulfate inhalation aerosol, but may produce severe bronchospasm in asthmatic patients. therefore, patients with asthma should not normally be treated with betaâblockers. however, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. in this setting, cardioselective beta-blockers should be considered, although they should be administered with caution. diuretics: the ecg changes and/or hypokalemia which may result from the administration of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. although the clinical significance of these effects is not known, caution is advised in th
Read more...e coadministration of beta-agonists with nonpotassium-sparing diuretics. albuterol-digoxin: mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. the clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear; nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol. monoamine oxidase inhibitors or tricyclic antidepressants: albuterol sulfate inhalation aerosol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the cardiovascular system may be potentiated.
Indications and Usage:
Indications and usage albuterol sulfate inhalation aerosol is indicated in adults and children 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
Warnings:
Warnings paradoxical bronchospasm: inhaled albuterol sulfate can produce paradoxical bronchospasm that may be life threatening. if paradoxical bronchospasm occurs, albuterol sulfate inhalation aerosol should be discontinued immediately and alternative therapy instituted. it should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister. deterioration of asthma: asthma may deteriorate acutely over a period of hours or chronically over several days or longer. if the patient needs more doses of albuterol sulfate inhalation aerosol than usual, this may be a marker of destabilization of asthma and requires re-evaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. use of anti-inflammatory agents: the use of beta-adrenergic-agonist bronchodilators alone may not be adequate to control asthma in many patients.
Read more...early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen. cardiovascular effects: albuterol sulfate inhalation aerosol, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. although such effects are uncommon after administration of albuterol sulfate inhalation aerosol at recommended doses, if they occur, the drug may need to be discontinued. in addition, beta-agonists have been reported to produce ecg changes, such as flattening of the t wave, prolongation of the qtc interval, and st segment depression. the clinical significance of these findings is unknown. therefore, albuterol sulfate inhalation aerosol, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. do not exceed recommended dose: fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. the exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected. immediate hypersensitivity reactions: immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.
Dosage and Administration:
Dosage and administration for treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual dosage for adults and children 4 years of age 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. each actuation of albuterol sulfate inhalation aerosol delivers 108 mcg of albuterol sulfate (equivalent to 90 mcg of albuterol base) from the mouthpiece. it is recommended 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 four "test sprays" into the air, away from the face. albuterol sulfate inhalation aerosol contains 200 inhalations per canister. the canister has an attached dose indicator, which indicates how many inhalations remain. the dose indicator display will move after every tenth actuation. when nearing the end of the usa
Read more...ble inhalations, the background behind the number in the dose indicator display window changes to red at 20 actuations or lower. albuterol sulfate inhalation aerosol should be discarded when the dose indicator display window shows zero. exercise induced bronchospasm prevention: the usual dosage for adults and children 4 years of age and older is two inhalations 15 to 30 minutes before exercise. to maintain proper use of this product, it is important that the mouthpiece be washed and dried thoroughly at least once a week. the inhaler may cease to deliver medication if not properly cleaned and dried thoroughly (see precautions, information for patients section). keeping the plastic mouthpiece clean is very important to prevent medication buildup and blockage. the inhaler may cease to deliver medication if not properly cleaned and air dried thoroughly. if the mouthpiece becomes blocked, washing the mouthpiece will remove the blockage. if a previously effective dose regimen fails to provide the usual response, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
Contraindications:
Contraindications albuterol sulfate inhalation aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other albuterol sulfate inhalation aerosol components.
Adverse Reactions:
Adverse reactions adverse reaction information concerning albuterol sulfate inhalation aerosol is derived from a 12âweek, double-blind, double-dummy study which compared albuterol sulfate inhalation aerosol, a cfc 11/12 propelled albuterol inhaler, and an hfa-134a placebo inhaler in 565 asthmatic patients. the following 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 inhalation aerosol treatment group and more frequently in the albuterol sulfate inhalation aerosol treatment group than in the placebo group. overall, the incidence and nature of the adverse reactions reported for albuterol sulfate inhalation aerosol and a cfc 11/12 propelled albuterol inhaler were comparable. adverse experience incidences (% of patients) in a large 12-week clinical trial this table includes all adverse events (whether considered by the investiga
Read more...tor drug related or unrelated to drug) which occurred at an incidence rate of at least 3.0% in the albuterol sulfate inhalation aerosol group and more frequently in the albuterol sulfate inhalation aerosol group than in the hfa-134a placebo inhaler group. body system/ adverse event (preferred term) albuterol sulfate inhalation aerosol (n=193) cfc 11/12 propelled albuterol inhaler (n=186) hfa-134a placebo inhaler (n=186) application site disorders inhalation site sensation 6 9 2 inhalation taste sensation 4 3 3 body as a whole allergic reaction/symptoms 6 4 <1 back pain 4 2 3 fever 6 2 5 central and peripheral nervous system tremor 7 8 2 gastrointestinal system nausea 10 9 5 vomiting 7 2 3 heart rate and rhythm disorder tachycardia 7 2 <1 psychiatric disorders nervousness 7 9 3 respiratory system disorders respiratory disorder (unspecified) 6 4 5 rhinitis 16 22 14 upper resp tract infection 21 20 18 urinary system disorder urinary tract infection 3 4 2 adverse events reported by less than 3% of the patients receiving albuterol sulfate inhalation aerosol, and by a greater proportion of albuterol sulfate inhalation aerosol patients than placebo patients, which have the potential to be related to albuterol sulfate inhalation aerosol include: dysphonia, increased sweating, dry mouth, chest pain, edema, rigors, ataxia, leg cramps, hyperkinesia, eructation, flatulence, tinnitus, diabetes mellitus, anxiety, depression, somnolence, rash. palpitation and dizziness have also been observed with albuterol sulfate inhalation aerosol. adverse events reported in a 4-week pediatric clinical trial comparing albuterol sulfate inhalation aerosol and a cfc 11/12 propelled albuterol inhaler occurred at a low incidence rate and were similar to those seen in the adult trials. in small, cumulative dose studies, tremor, nervousness, and headache appeared to be dose related. rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of inhaled albuterol. in addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, insomnia, headache, metabolic acidosis, and drying or irritation of the oropharynx. to report suspected adverse reactions, contact cipla ltd at 1-866-604-3268 or fda at 1-800-fda-1088 or www.fda.gov/medwatch .
Adverse Reactions Table:
Adverse Experience Incidences (% of patients) in a Large 12-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 inhalation aerosol group and more frequently in the Albuterol sulfate inhalation aerosol group than in the HFA-134a placebo inhaler group.| Body System/Adverse Event (Preferred Term) | Albuterol Sulfate Inhalation Aerosol(N=193) | CFC 11/12 Propelled Albuterol Inhaler(N=186) | HFA-134a Placebo Inhaler(N=186) |
| Application Site Disorders | Inhalation Site Sensation | 6 | 9 | 2 |
| Inhalation Taste Sensation | 4 | 3 | 3 |
| Body as a Whole | Allergic Reaction/Symptoms | 6 | 4 | <1 |
| Back Pain | 4 | 2 | 3 |
| Fever | 6 | 2 | 5 |
| Central and Peripheral Nervous System | Tremor | 7 | 8 | 2 |
| Gastrointestinal System | Nausea | 10 | 9 | 5 |
| Vomiting | 7 | 2 | 3 |
| Heart Rate and Rhythm Disorder | Tachycardia | 7 | 2 | <1 |
| Psychiatric Disorders | Nervousness | 7 | 9 | 3 |
| Respiratory System Disorders | Respiratory Disorder (unspecified) | 6 | 4 | 5 |
| Rhinitis | 16 | 22 | 14 |
| Upper Resp Tract Infection | 21 | 20 | 18 |
| Urinary System Disorder | Urinary Tract Infection | 3 | 4 | 2 |
Drug Interactions:
Drug interactions beta-blockers: beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as albuterol sulfate inhalation aerosol, but may produce severe bronchospasm in asthmatic patients. therefore, patients with asthma should not normally be treated with betaâblockers. however, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. in this setting, cardioselective beta-blockers should be considered, although they should be administered with caution. diuretics: the ecg changes and/or hypokalemia which may result from the administration of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. although the clinical significance of these effects is not known, caution is advised in th
Read more...e coadministration of beta-agonists with nonpotassium-sparing diuretics. albuterol-digoxin: mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. the clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear; nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol. monoamine oxidase inhibitors or tricyclic antidepressants: albuterol sulfate inhalation aerosol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the cardiovascular system may be potentiated.
Overdosage:
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, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. hypokalemia may also occur. as with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of albuterol sulfate inhalation aerosol. treatment consists of discontinuation of albuterol sulfate inhalation aerosol together with appropriate symptomatic therapy. the judicious use of a cardio selective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. there is insufficient evidence to determine if dialysis is beneficial for overdosage of albuterol sulfate inhalation aerosol. the oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 6800 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 3200 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). in mature rats, the subcutaneous median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 3000 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 1400 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). in young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m 2 basis and approximately 6400 times the maximum recommended daily inhalation dose for children on a mg/m 2 basis). the inhalation median lethal dose has not been determined in animals.
Description:
Description the active component of albuterol sulfate inhalation aerosol is albuterol sulfate, usp racemic α 1 [( tert- butylamino)methyl]-4-hydroxy- m -xylene-α,α'-diol sulfate (2:1)(salt), a relatively selective beta 2 -adrenergic bronchodilator having the following chemical structure: albuterol sulfate is the official generic name in the united states. the world health organization recommended name for the drug is salbutamol sulfate. the molecular weight of albuterol sulfate is 576.7, and the empirical formula is (c 13 h 21 no 3 ) 2 â¢h 2 so 4 . albuterol sulfate is a white to off-white crystalline solid. it is soluble in water and slightly soluble in ethanol. albuterol sulfate inhalation aerosol is a pressurized metered-dose aerosol unit for oral inhalation. it contains a microcrystalline suspension of albuterol sulfate in propellant hfa-134a (1,1,1,2-tetrafluoroethane), ethanol, and oleic acid. each actuation delivers 120 mcg albuterol sulfate, usp from the valve and 108 mcg albuterol sulfate, usp from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). each canister provides 200 inhalations. it is recommended 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 four "test sprays" into the air, away from the face. this product does not contain chlorofluorocarbons (cfcs) as the propellant. structural formula
Clinical Pharmacology:
Clinical pharmacology mechanism of action in vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta 2 -adrenergic receptors compared with isoproterenol. while it is recognized that beta 2 -adrenergic receptors are the predominant receptors on bronchial smooth muscle, data indicate that there is a population of beta 2 -receptors in the human heart existing in a concentration between 10% and 50% of cardiac beta-adrenergic receptors. the precise function of these receptors has not been established. (see warnings, cardiovascular effects section.) activation of beta 2 -adrenergic receptors on airway smooth muscle leads to the activation of adenylcyclase and to an increase in the intracellular concentration of cyclic-3',5'-adenosine monophosphate (cyclic amp). this increase of cyclic amp leads to the activation of protein kinase a, which inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, re
Read more...sulting in relaxation. albuterol relaxes the smooth muscles of all airways, from the trachea to the terminal bronchioles. albuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges. increased cyclic amp concentrations are also associated with the inhibition of release of mediators from mast cells in the airway. albuterol has been shown in most clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. controlled clinical studies and other clinical experience have shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes. preclinical intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately 5% of the plasma concentrations. in structures outside the blood-brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those in the whole brain. studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta 2 -agonist and methylxanthines were administered concurrently. the clinical significance of these findings is unknown. propellant hfa-134a is devoid of pharmacological activity except at very high doses in animals (380â1300 times the maximum human exposure based on comparisons of auc values), primarily producing ataxia, tremors, dyspnea, or salivation. these are similar to effects produced by the structurally related chlorofluorocarbons (cfcs), which have been used extensively in metered dose inhalers. in animals and humans, propellant hfa-134a was found to be rapidly absorbed and rapidly eliminated, with an elimination half-life of 3 to 27 minutes in animals and 5 to 7 minutes in humans. time to maximum plasma concentration (t max ) and mean residence time are both extremely short, leading to a transient appearance of hfa-134a in the blood with no evidence of accumulation. pharmacokinetics in a single-dose bioavailability study which enrolled six healthy, male volunteers, transient low albuterol levels (close to the lower limit of quantitation) were observed after administration of two puffs from both albuterol sulfate inhalation aerosol and a cfc 11/12 propelled albuterol inhaler. no formal pharmacokinetic analyses were possible for either treatment, but systemic albuterol levels appeared similar. clinical trials in a 12-week, randomized, double-blind, double-dummy, active- and placebo-controlled trial, 565 patients with asthma were evaluated for the bronchodilator efficacy of albuterol sulfate inhalation aerosol (193 patients) in comparison to a cfc 11/12 propelled albuterol inhaler (186 patients) and an hfa-134a placebo inhaler (186 patients). serial fev 1 measurements (shown below as percent change from test-day baseline) demonstrated that two inhalations of albuterol sulfate inhalation aerosol produced significantly greater improvement in pulmonary function than placebo and produced outcomes which were clinically comparable to a cfc 11/12 propelled albuterol inhaler. the mean time to onset of a 15% increase in fev 1 was 6 minutes and the mean time to peak effect was 50 to 55 minutes. the mean duration of effect as measured by a 15% increase in fev 1 was 3 hours. in some patients, duration of effect was as long as 6 hours. in another clinical study in adults, two inhalations of albuterol sulfate inhalation aerosol taken 30 minutes before exercise prevented exercise-induced bronchospasm as demonstrated by the maintenance of fev 1 within 80% of baseline values in the majority of patients. in a 4-week, randomized, open-label trial, 63 children, 4 to 11 years of age, with asthma were evaluated for the bronchodilator efficacy of albuterol sulfate inhalation aerosol (33 pediatric patients) in comparison to a cfc 11/12 propelled albuterol inhaler (30 pediatric patients). serial fev 1 measurements as percent change from test-day baseline demonstrated that two inhalations of albuterol sulfate inhalation aerosol produced outcomes which were clinically comparable to a cfc 11/12 propelled albuterol inhaler. the mean time to onset of a 12% increase in fev 1 for albuterol sulfate inhalation aerosol was 7 minutes and the mean time to peak effect was approximately 50 minutes. the mean duration of effect as measured by a 12% increase in fev 1 was 2.3 hours. in some pediatric patients, duration of effect was as long as 6 hours. in another clinical study in pediatric patients, two inhalations of albuterol sulfate inhalation aerosol taken 30 minutes before exercise provided comparable protection against exercise-induced bronchospasm as a cfc 11/12 propelled albuterol inhaler. fev1 as percent change from predose in a large 12-week clinical trial
How Supplied:
How supplied albuterol sulfate inhalation aerosol is supplied as a pressurized aluminum canister with an attached dose indicator, a white plastic actuator and orange dust cap each in boxes of one. each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). each canister with a labeled net weight of 6.7 g contain 200 inhalations are supplied in a carton as ndc 60687-662-91. rx only. store at 20°c to 25°c (68°f to 77°f). [see usp controlled room temperature.] store the inhaler with the mouthpiece down. for best results, canister should be at room temperature before use. shake well before using. the white actuator supplied with albuterol sulfate inhalation aerosol should not be used with any other product canisters, and actuator from other products should not be used with an albuterol sulfate inhalation aerosol canister. the correct amount of medication in each canister canno
Read more...t be assured after 200 actuations and when the dose indicator display window shows zero, even though the canister is not completely empty. the canister should be discarded when the labeled number of actuations have been used. warning: avoid spraying in eyes. contents under pressure. do not puncture or incinerate. exposure to temperatures above 120°f may cause bursting. keep out of reach of children. albuterol sulfate inhalation aerosol does not contain chlorofluorocarbons (cfcs) as the propellant. manufactured by: cipla ltd. indore sez, pithampur, india. distributed by: american health packaging columbus, ohio 43217 disclaimer: all trademarks are property of their respective owners. issued: 8/2022
Package Label Principal Display Panel:
Package/label display panel â carton â 90 mcg ndc 60687- 662 -91 rx only albuterol sulfate inhalation aerosol 90 mcg* with dose indicator for oral inhalation with enclosed actuator only 200 metered inhalations contains no chlorofluorocarbons (cfcs). net contents 6.7 g warnings: the action of albuterol sulfate inhalation aerosol may last up to 6 hours and therefore it should not be used more frequently than recommended. increasing the number or frequency of doses without consulting your physician can be dangerous. if recommended dosage does not provide relief of symptoms or symptoms become works, seek immediate medical attention. when taking albuterol sulfate inhalation aerosol, other inhaled medicine should be used only as prescribed by your physician. avoid spraying in eyes. contents under pressure. do not puncture. do not use or store near heat or open flame. exposure to temperatures above 120°f may cause bursting. never throw container into fire or incinerator. keep out of reach of children. *each actuation delivers 108 mcg albuterol sulfate, usp equivalent to 90 mcg albuterol from the mouthpiece. see package insert for full prescribing information. attention health care professional: detach patientâs leaflet of instructions from package insert and dispense with inhaler. usual dosage: use only as directed by your physician. contents: each canister contains a microcrystalline suspension of albuterol sulfate in propellant hfa-134a, ethanol and oleic acid. important: read accompanying directions carefully. store at 20°c to 25°c (68°f to 77°f. [see usp controlled room temperature.] store inhaler with mouthpiece down. shake well before using. m.l. 25/2/2010 manufactured by: cipla ltd. indore sez, pithampur, india. distributed by: american health packaging columbus, ohio 43217 iss. 4/2022 90 mcg albuterol sulfate inhalation aerosol carton
Package/label display panel â canister â 90 mcg ndc 60687- 662 -91 rx only albuterol sulfate inhalation aerosol 90 mcg* with dose indicator for oral inhalation with enclosed actuator only 200 metered inhalations net contents 6.7 g *contents: each actuation delivers from the mouth- piece a microcrystalline suspension of albuterol sulfate equivalent to 90 mcg albuterol in propellant (hfa-134a), ethanol and oleic acid. warning: do not exceed the dose prescribed by your physician. if difficulty in breathing persists, seek medical attention immediately. see package insert for full prescribing information. store at 20°c to 25°c (68°f to 77°f. [see usp controlled room temperature.] store inhaler with mouthpiece down. shake well before using. manufactured by: cipla ltd. indore sez, pithampur, india. distributed by: american health packaging columbus, ohio 43217 220965 iss. 4/2022 m.l. 25/2/2010 90 mcg albuterol sulfate inhalation aerosol canister