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ALBUTEROL SULFATE 90 ug Aerosol, Metered — NDC 51662-1513-01 package photo

ALBUTEROL SULFATE 90 ug Aerosol, Metered

by HF Acquisition Co LLC, DBA HealthFirst · 1 INHALER in 1 CARTON (51662-1513-1) / 200 AEROSOL, METERED in 1 INHALER
NDC 51662-1513-01
🏷️ FDA NDC (as labeled) 51662-1513-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Albuterol Sulfate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Jul 24, 2025 — Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point. (Cipla USA, Inc.) · FDA recall D-0593-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 51662-1513-1
Product NDC 51662-1513
11-digit billing NDC 51662151301
RxCUI 2123072
UNII 021SEF3731
Application # ANDA203760
SPL Set ID ad299502-8779-d280-e053-2995a90a7371
Established class (EPC) beta2-Adrenergic Agonist
Mechanism of action Adrenergic beta2-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-08-18
Route RESPIRATORY (INHALATION)
Dosage form AEROSOL, METERED
Substance ALBUTEROL SULFATE
TE code (Orange Book) AB2 · RLD · RS
Why two NDCs? The FDA registers this code as 51662-1513-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 51662-1513-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the beta2-Adrenergic Agonist class.

Pharmacologic class beta2-Adrenergic Agonist
Drug family (ATC) Selective beta-2-adrenoreceptor agonists, Selective beta-2-adrenoreceptor agonists
How it works Adrenergic beta2-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerHF Acquisition Co LLC, DBA HealthFirst
Application holderPADAGIS US LLC
FDA applicationANDA203760 (ANDA)
Labeler code51662
First marketedAug 2020
Product typeHuman Prescription Drug
Portfolio333 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Albuterol is used to prevent and treat difficulty breathing, wheezing, shortness of breath, coughing, and chest tightness caused by lung diseases such as asthma and chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways). Albuterol inhalation aerosol and powder for oral inhalation is also used to prevent breathing difficulties during exercise. Albuterol inhalation aerosol (Proair HFA, Proventil HFA, Ventolin HFA) is used in adults and children 4 years of age and older. Albuterol powder for oral inhalation (Proair Respiclick) is used in children 12 ye...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Albuterol quickly relaxes the muscles around your airways, opening them up so you can breathe more easily. Think of it as a fast-acting rescue medicine — you use it when you feel y...
  • What exactly does albuterol do, and when should I use it?
  • That depends on which inhaler you have. If you have a standard HFA inhaler (like Ventolin HFA or Albuterol Sulfate HFA), shake it well before every puff and prime it with a few tes...
  • The most common side effects are pretty mild — a scratchy throat, cough, or upper respiratory irritation, and sometimes a slightly faster heartbeat, shakiness, or headache. Those u...
📖 Read our full Albuterol guide →
2
Nutrient depletion considerations

Albuterol Sulfate may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Albuterol Sulfate nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII DH9E53K1Y8
    A synthetic fluorinated hydrocarbon used primarily as a propellant or aerosol dispersant in pressurized inhaler formulations to help deliver medication to the lungs.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $2.82 $563.56 / 200 aerosols
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Albuterol Sulfate HFA 90 ug 00093-3174-31 Teva 1 inhaler $1.553 AB2 Availability likely —
Albuterol Sulfate 90 ug 17270-0740-00 Armstrong 1 inhaler $1.553 AB2 Availability likely —
albuterol sulfate 90 ug 45802-0088-01 Padagis 1 inhaler $1.553 AB2 Availability likely —
Albuterol sulfate 90 ug 68180-0963-01 Lupin 1 canister $1.553 AB2 Availability likely —
Albuterol Sulfate Inhalation 90 ug 69238-1291-01 Amneal 1 canister $1.553 AB2 Availability likely —
Albuterol Sulfate HFA 90 ug 66993-0019-68 Prasco 1 inhaler $1.819 AB3 Availability likely —
Albuterol 90 ug 69097-0021-60 Cipla 1 inhaler $1.819 AB3 Availability likely —
Albuterol Sulfate 90 ug 76282-0679-42 Exelan 1 canister $2.126 AB1 Availability likely —
Albuterol Sulfate 90 ug 00054-0742-87 Hikma 1 canister $2.126 AB1 Availability likely —
Albuterol Sulfate 90 ug 60687-0662-91 American 1 canister $2.126 AB1 Availability likely —
Albuterol Sulfate 90 ug 69097-0142-60 Cipla 1 canister $2.126 AB1 Availability likely —
Ventolin Hfa 90 ug 00173-0682-20 GlaxoSmithKline 1 inhaler $3.035 AB3 Availability likely —
ProAir Digihaler 90 ug 59310-0117-20 Teva 1 inhaler $86.326 — FDA listed —
Albuterol sulfate 90 ug 50090-5231-00 A-S 1 canister — AB2 FDA listed —
Albuterol Sulfate 90 ugthis 51662-1513-01 HF 1 inhaler — AB2 FDA listed —
Albuterol sulfate 90 ug 68071-2300-02 NuCare 1 canister — AB2 FDA listed —
Albuterol Sulfate 90 ug 68071-3902-02 NuCare 1 inhaler — AB2 FDA listed —
Albuterol Sulfate HFA 90 ug 68071-4940-02 NuCare 200 aerosols — AB2 FDA listed —
Albuterol Sulfate 90 ug 68788-4041-02 Preferred 1 inhaler — AB2 FDA listed —
Albuterol sulfate 90 ug 68788-8878-02 Preferred 1 canister — AB2 FDA listed —
Albuterol sulfate 90 ug 70518-3541-00 REMEDYREPACK 1 canister — AB2 FDA listed —
Albuterol Sulfate 90 ug 70518-4496-00 REMEDYREPACK 1 inhaler — AB2 FDA listed —
Albuterol Sulfate HFA 90 ug 71205-0211-85 Proficient 1 inhaler — AB2 FDA listed —
albuterol sulfate 90 ug 71205-0441-85 Proficient 1 inhaler — AB2 FDA listed —
Albuterol sulfate 90 ug 71205-0732-85 Proficient 1 canister — AB2 FDA listed —
Albuterol Sulfate HFA 90 ug 76420-0088-01 Asclemed 1 inhaler — AB2 FDA listed —
Albuterol sulfate 90 ug 76420-0350-90 Asclemed 1 canister — AB2 FDA listed —
Albuterol Sulfate 90 ug 80425-0266-01 Advanced 1 canister — AB2 FDA listed —
albuterol sulfate 90 ug 85766-0055-90 Sportpharm 1 inhaler — AB2 FDA listed —
Albuterol sulfate 90 ug 85766-0062-90 Sportpharm 1 canister — AB2 FDA listed —
albuterol sulfate HFA 90 ug 50090-4137-00 A-S 1 inhaler — AB3 FDA listed —
Ventolin Hfa 90 ug 63187-0026-08 Proficient 60 aerosols — AB3 FDA listed —
Albuterol Sulfate 90 ug 76420-0531-01 Asclemed 200 aerosols — AB1 FDA listed —
Albuterol Sulfate 90 ug 68788-8874-02 Preferred 1 canister — AB1 FDA listed —
Ventolin Hfa 90 ug 50090-1158-00 A-S 1 inhaler — AB3 FDA listed —
Albuterol Sulfate 90 ug 51662-1267-01 HF 1 inhaler — AB3 FDA listed —
Ventolin Hfa 90 ug 68071-1890-06 NuCare 60 aerosols — AB3 FDA listed —
Ventolin Hfa 90 ug 70518-1081-00 REMEDYREPACK 200 aerosols — AB3 FDA listed —
Ventolin Hfa 90 ug 70518-1237-00 REMEDYREPACK 1 inhaler — AB3 FDA listed —
Albuterol Sulfate 90 ug 50090-5735-01 A-S 96 canisters — AB1 FDA listed —
Albuterol Sulfate HFA 90 ug 80425-0359-01 Advanced 1 inhaler — AB3 FDA listed —
Albuterol Sulfate 90 ug 50090-5179-00 A-S 1 canister — AB1 FDA listed —
Ventolin Hfa 90 ug 50090-1159-00 A-S 1 inhaler — AB3 FDA listed —
Albuterol Sulfate 90 ug 68788-8787-02 Preferred 1 canister — AB1 FDA listed —
Albuterol Sulfate 90 ug 82804-0189-67 Proficient 1 canister — AB1 FDA listed —
Ventolin Hfa 90 ug 68071-1670-02 NuCare 200 aerosols — AB3 FDA listed —
Albuterol Sulate HFA 90 ug 70518-2072-00 REMEDYREPACK 1 inhaler — AB3 FDA listed —
Albuterol Sulfate 90 ug 85766-0020-90 Sportpharm 1 canister — AB1 FDA listed —
Albuterol Sulate HFA 90 ug 68071-4777-02 NuCare 200 aerosols — AB3 FDA listed —
Albuterol Sulfate 90 ug 85534-0039-00 HAWAII 1 canister — AB1 FDA listed —
Albuterol Sulfate 90 ug 68071-5312-06 NuCare 1 canister — AB1 FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2020
On the market since
Aug 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Albuterol Sulfate — the program that covers self-administered drugs. 14 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Albuterol Sulfate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.45M
Claims incl. refills
74.8K
Beneficiaries
44.4K
Spend / beneficiary
$55.14
Spend / claim
$32.72
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Albuterol Sulfate — the ingredient across all brands.

Top reported reactions

Dyspnoea42,946
Asthma24,941
Cough20,428
Fatigue16,816
Pneumonia16,771
Headache15,685
Nausea14,693

Reporter sex

297,526 reports

Serious outcomes

Death18,793
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 29,981 14,207
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51662-1513-01 You're viewing this 1 INHALER in 1 CARTON (51662-1513-1) / 200 AEROSOL, METERED in 1 INHALER 2020-08-18 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 51662-1513-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51662-1513-01, written without dashes as 51662151301. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51662-1513-01, the first segment (51662) is the labeler code FDA assigned to HF Acquisition Co LLC, DBA HealthFirst; the middle segment (1513) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by HF Acquisition Co LLC, DBA HealthFirst. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
HF Acquisition Co LLC, DBA HealthFirst is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Patient Medication Information
🎯 Indications and Usage 54 words ▾

INDICATIONS AND USAGE

1.1Bronchospasm 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.

1.2Exercise-Induced Bronchospasm Albuterol sulfate inhalation aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION

2.1Bronchospasm 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.

2.2Exercise-Induced Bronchospasm The usual dosage for adults and children 4 years of age or older is two inhalations 15 to 30 minutes before exercise.

2.3Administration Information Administer Albuterol sulfate inhalation aerosol 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 inhalation aerosol 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 inhalation aerosol actuator and never attach the Albuterol sulfate inhalation aerosol 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, put the cap on the mouthpiece, replace canister, remove the cap from the mouthpiece, 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 inhalation aerosol has a dose counter attached to the actuator. When the patient receives the inhaler, the number 203 will appear in the viewing window and will count down during each of three priming sprays, 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 patient should contact their pharmacist for a refill of medication or consult their physician for a prescription refill. When it is time to obtain a new inhaler a red flag will begin to show in the window, getting larger as the number of doses remaining approaches 0.

The red flag will remind the patient that a new inhaler is needed. When the dose counter reaches 0, a very large 0 with a solid red background will appear in the window. Albuterol sulfate inhalation aerosol inhaler should be discarded when the dose counter displays 0 or after the expiration date on the product, whichever comes first.

💊 Dosage Forms and Strengths 73 words ▾

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 white plastic actuator with a dose counter and red 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).

⛔ Contraindications 48 words ▾

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 hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see Warnings and Precautions (5.6)].

⚠️ Warnings and Cautions ~2 min read ▾

WARNINGS AND PRECAUTIONS

5.1Paradoxical Bronchospasm Albuterol sulfate inhalation aerosol 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.

5.2Deterioration 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.

5.3Use of Anti-inflammatory Agents The use of beta-adrenergic-agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen.

5.4Cardiovascular 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.

5.5Do 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.

5.6Immediate 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. The potential for hypersensitivity must be considered in the clinical evaluation of patients who experience immediate hypersensitivity reactions while receiving albuterol sulfate inhalation aerosol.

5.7Coexisting Conditions 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; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.

Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

5.8Hypokalemia As with other beta-agonists, albuterol sulfate inhalation aerosol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTION Use of albuterol sulfate inhalation aerosol 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)]

6.1Clinical Trials Experience A total of 1090 subjects were treated with albuterol sulfate inhalation aerosol, or with the same formulation of albuterol as in Albuterol sulfate 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 inhalation aerosol is derived from a 6-week, blinded study which compared albuterol sulfate 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 inhalation aerosol treatment group and more frequently in the albuterol sulfate inhalation aerosol treatment group than in the matched placebo group. Overall, the incidence and nature of the adverse events reported for albuterol sulfate inhalation aerosol and the marketed active comparator HFA-134a albuterol inhaler were comparable. *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 placebo HFA inhalation aerosol group.

Adverse events reported by less than 3% of the patients receiving albuterol sulfate inhalation aerosol but by a greater proportion of albuterol sulfate inhalation aerosol patients than the matched placebo patients, which have the potential to be related to albuterol sulfate 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 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.

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of albuterol sulfate inhalation aerosol. 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 arrhyt…

🔄 Drug Interactions ~1 min read ▾

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 any route, they should be used with caution to avoid deleterious cardiovascular effects.

7.1Beta-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 beta-blockers. 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, consider cardioselective beta-blockers, although they should be administered with caution.

7.2Diuretics The ECG changes and/or hypokalemia which may result from the administration of non-potassium 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 the coadministration of beta-agonists with non-potassium sparing diuretics. Consider monitoring potassium levels.

7.3Digoxin 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 sulfate inhalation aerosol.

7.4Monoamine 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. Consider alternative therapy in patients taking MAO inhibitors or tricyclic antidepressants.

👥 Use in Specific Populations ~3 min read ▾

USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy. For more information, contact the Mothers To Baby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1-877-311-8972 or visit http://mothertobaby.org/pregnancy-studies/. Risk Summary There are no randomized clinical studies of use of albuterol during pregnancy.

Available data from published epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. There are clinical considerations with use of albuterol in pregnant women [see Clinical Considerations]. In animal reproduction studies, when albuterol sulfate was administered subcutaneously to pregnant mice there was evidence of cleft palate at less than and up to 9 times the maximum recommended human daily inhalation dose (MRHDID) [see Data].

The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk In women with poorly or moderately controlled asthma, there is an increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate.

Pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control. Labor or Delivery Because of the potential for beta-agonist interference with uterine contractility, use of PROAIR HFA Inhalation Aerosol for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. PROAIR HFA Inhalation Aerosol has not been approved for the management of pre-term labor.

Serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including albuterol. Data Animal Data In a mouse reproduction study, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure nine-tenths of the MRHDID for adults (on a mg/m2 basis at a maternal dose of 0.25 mg/kg) and in 10 of 108 (9.3%) fetuses at approximately 9 times the MRHDID (on a mg/m2 basis at a maternal dose of 2.5 mg/kg).

Similar effects were not observed at approximately one-eleventh the MRHDID for adults (on a mg/m2 basis at a maternal dose of 0.025 mg/kg). Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol (positive control). In a rabbit reproduction study, orally administered albuterol sulfate induced cranioschisis in 7 of 19 fetuses (37%) at approximately 750 times the MRHDID (on a mg/m2 basis at a maternal dose of 50 mg/kg).

In a rat reproduction study, an albuterol sulfate/HFA-134a formulation administered by inhalation did not produce any teratogenic effects at exposures approximately 80 times the MRHDID (on a mg/m2 basis at a maternal dose of 10.5 mg/kg). A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus.

8.2Lactation Risk Summary There are no available data on the presence of albuterol in human milk, the effects on the breastfed child, or the effects on milk production. However, plasma levels of albuterol after inhaled therapeutic doses are low in humans, and if present in breast milk, albuterol has a low oral bioavailability [see Clinical Pharmacology (12.3)]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for albutero…

🆘 Overdosage ~1 min read ▾

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 cardioselective 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 2,000 mg/kg (approximately 6,800 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximately 3,200 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). In mature rats, the subcutaneous median lethal dose of albuterol sulfate is approximately 450 mg/kg (approximately 3,000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximately 1,400 times the maximum recommended daily inhalation dose for children on a mg/m2 basis).

In young rats, the subcutaneous median lethal dose is approximately 2,000 mg/kg (approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis and approximately 6,400 times the maximum recommended daily inhalation dose for children on a mg/m2 basis). The inhalation median lethal dose has not been determined in animals.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY

12.1Mechanism 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 smooth muscle. Activation of beta2-adrenergic receptors 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 is associated with the activation of protein kinase A, which in turn inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in muscle relaxation. Albuterol relaxes the smooth muscle 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. While it is recognized that beta2-adrenergic receptors are the predominant receptors on bronchial smooth muscle, data indicate that there are beta-receptors in the human heart, 10% to 50% of which are cardiac beta2-adrenergic receptors. The precise function of these receptors has not been established [see Warnings and Precautions (5.4)].

Albuterol has been shown in most controlled 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. However, 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 [see Warnings and Precautions (5.4)].

12.2Pharmacokinetics The systemic levels of albuterol are low after inhalation of recommended doses. In a crossover study conducted in healthy male and female volunteers, high cumulative doses of albuterol sulfate inhalation aerosol (1,080 mcg of albuterol base administered over one hour) yielded mean peak plasma concentrations (Cmax) and systemic exposure (AUCinf) of approximately 4,100 pg/mL and 28,426 pg/mL*hr, respectively compared to approximately 3,900 pg/mL and 28,395 pg/mL*hr, respectively following the same dose of an active HFA-134a albuterol inhaler comparator.

The terminal plasma half-life of albuterol delivered by albuterol sulfate inhalation aerosol was approximately 6 hours. Comparison of the pharmacokinetic parameters demonstrated no differences between the products. The pharmacokinetic profile of albuterol sulfate inhalation aerosol was evaluated in a two-way cross-over study in 11 healthy pediatric volunteers, 4 to 11 years of age.

A single dose administration of albuterol sulfate inhalation aerosol (180 mcg albuterol base) yielded a least square mean (SE) Cmax and AUC0-∞ of 1,100 (1.18) pg/mL and 5,120 (1.15) pg/mL*hr, respectively. The least square mean (SE) terminal plasma half-life of albuterol delivered by albuterol sulfate inhalation aerosol was 166 (7.8) minutes. Metabolism and Elimination: Information available in the published literature suggests that the primary enzyme responsible for the metabolism of albuterol in humans is SULTIA3 (sulfotransferase).

When racemic albuterol was administered either intravenously or via inhalation after oral charcoal administration, there was a 3- to 4-fold difference in the area under the concentration-time curves between the (R)- and (S)-albuterol enantiomers, with (S)-albuterol concentrations being consistently higher. However, without charcoal pretreatment, after either oral or inhalation administration the differences were 8- to 24-fold, suggesting that the (R)-albuterol is preferentially metabolized in the gastrointestinal tract, presumably by SULTIA3.

The primary route of elimination of albuterol is through renal excr…

📦 How Supplied / Storage and Handling ~1 min read ▾

HOW SUPPLIED/STORAGE & HANDLING Albuterol sulfate inhalation aerosol is supplied as a pressurized aluminum canister with a white plastic actuator with a dose counter and red dust cap each in boxes of one. Each canister contains 8.5 g of the formulation and provides 200 actuations (NDC 45802-088-01). 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 at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. 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 white actuator supplied with albuterol sulfate inhalation aerosol should not be used with the canister from any other inhalation aerosol products. The albuterol sulfate inhalation aerosol canister should not be used with the actuator from any other inhalation aerosol products.

Albuterol sulfate inhalation aerosol 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 parts inside the actuator. Discard the albuterol sulfate inhalation aerosol 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 inhalation aerosol does not contain chlorofluorocarbons (CFCs) as the propellant.

📋 Description 201 words ▾

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) 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 (C13H21NO3)2•H2SO4. 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 inhalation aerosol 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.

DESCRIPTION

💬 Patient Medication Information ~3 min read ▾

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 you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is Albuterol Sulfate Inhalation Aerosol? Albuterol Sulfate Inhalation Aerosol is a prescription medicine used in people 4 years of age and older to: • treat or prevent bronchospasm in people who have reversible obstructive airway disease • prevent exercise induced bronchospasm It is not known if Albuterol Sulfate Inhalation Aerosol is safe and effective in children under 4 years of age. Who should not use Albuterol Sulfate Inhalation Aerosol?

Do not use Albuterol Sulfate Inhalation Aerosol if you are allergic to albuterol sulfate or any of the ingredients in Albuterol Sulfate Inhalation Aerosol. See the end of this leaflet for a complete list of ingredients in Albuterol Sulfate Inhalation Aerosol. What should I tell my doctor before I use Albuterol Sulfate Inhalation Aerosol?

Before you use Albuterol Sulfate Inhalation Aerosol, tell your doctor if you: • have heart problems • have high blood pressure (hypertension) • have convulsions (seizures) • have thyroid problems • have diabetes • have low potassium levels in your blood • are pregnant or plan to become pregnant. It is not known if Albuterol Sulfate Inhalation Aerosol will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. • are breastfeeding or plan to breastfeed.

It is not known if Albuterol Sulfate Inhalation Aerosol passes into your breast milk. Talk to your doctor about the best way to feed your baby if you are using Albuterol Sulfate Inhalation Aerosol. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Albuterol Sulfate Inhalation Aerosol and other medicines may affect each other and cause side effects. Albuterol Sulfate Inhalation Aerosol may affect the way other medicines work, and other medicines may affect the way Albuterol Sulfate Inhalation Aerosol works. Especially tell your doctor if you take: • other inhaled medicines or asthma medicines • beta blocker medicines • diuretics • digoxin • monoamine oxidase inhibitors • tricyclic antidepressants Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I use Albuterol Sulfate Inhalation Aerosol? • For detailed instructions, see “Instructions for Use” at the end of this Patient Information. • Use Albuterol Sulfate Inhalation Aerosol exactly as your doctor tells you to use it. • If your child needs to use Albuterol Sulfate Inhalation Aerosol, watch your child closely to make sure your child uses the inhaler correctly.

Your doctor will show you how your child should use Albuterol Sulfate Inhalation Aerosol. • Each dose of Albuterol Sulfate Inhalation Aerosol should last up to 4 hours to 6 hours. • Do not increase your dose or take extra doses of Albuterol Sulfate Inhalation Aerosol without first talking to your doctor. • Get medical help right away if Albuterol Sulfate Inhalation Aerosol no longer helps your symptoms. • Get medical help right away if your symptoms get worse or if you need to use your inhaler more often. • While you are using Albuterol Sulfate Inhalation Aerosol, do not use other inhaled rescue medicines and asthma medicines unless your doctor tells you to do so. • Call your doctor if your asthma symptoms like wheezing and trouble breathing become worse over a few hours or days.

Your doctor may need to give you another medicine (for example, corticosteroids) to treat your symptoms. What are the possible side effects of Albuterol Sulfate Inhalation Aerosol? Albuterol Sulfate Inha…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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