These highlights do not include all the information needed to use BREYNA safely and effectively. See full prescribing information for BREYNA . BREYNA ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

BREYNA is available as a metered-dose inhaler containing a combination of budesonide (80 mcg or 160 mcg) and formoterol fumarate dihydrate (4.5 mcg) as an inhalation aerosol in the following two strengths: 80 mcg/4.5 mcg and 160 mcg/4.5 mcg. Each dosage strength contains 120 actuations per/canister. Each strength of BREYNA is supplied with a blue plastic actuator with a grey dust cap.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

The use of BREYNA is contraindicated in the following conditions: • Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required. • Hypersensitivity to any of the ingredients in BREYNA.

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

LABA use may result in the following: • Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions (5.1) ] . • Cardiovascular and central nervous system effects [see Warnings and Precautions (5.12) ] . Systemic and inhaled corticosteroid use may result in the following: • Candida albicans infection [see Warnings and Precautions (5.4) ] • Pneumonia or lower respiratory tract infections in patients with COPD [see Warnings and Precautions (5.5) ] • Immunosuppression [see Warnings and Precautions (5.6) ] • Hypercorticism and adrenal suppression [see Warnings and Precautions (5.8) ] • Growth effects in pediatric patients [see Warnings and Precautions (5.14) ] • Glaucoma and cataracts [see Warnings and Precautions (5.15) ] 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.

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

In clinical studies, concurrent administration of budesonide and formoterol fumarate dihydrate inhalation aerosol and other drugs, such as short-acting beta 2 -agonists, intranasal corticosteroids, and antihistamines/decongestants has not resulted in an increased frequency of adverse reactions. No formal drug interaction studies have been performed with budesonide and formoterol fumarate dihydrate inhalation aerosol.

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

BREYNA BREYNA contains both budesonide and formoterol fumarate dihydrate; therefore, the risks associated with overdosage for the individual components described below apply to BREYNA. In pharmacokinetic studies, single doses of 960/54 mcg (12 actuations of budesonide and formoterol fumarate dihydrate inhalation aerosol 80 mcg/4.5 mcg) and 1280/36 mcg (8 actuations of 160 mcg/4.5 mcg), were administered to patients with COPD. A total of 1920/54 mcg (12 actuations of budesonide and formoterol fumarate dihydrate inhalation aerosol 160 mcg/4.5 mcg) was administered as a single dose to both healthy subjects and patients with asthma. In a long-term active-controlled safety study in adolescent and adult asthma patients 12 years of age and older, budesonide and formoterol fumarate dihydrate inhalation aerosol 160 mcg/4.5 mcg was administered for up to 12 months at doses up to twice the highest recommended daily dose. There were no clinically significant adverse reactions observed in any of these studies. Budesonide The potential for acute toxic effects following overdose of budesonide is low. If used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism may occur [see Warnings and Precautions (5) ] . Budesonide at five times the highest recommended dose (3200 mcg daily) administered to humans for 6 weeks caused a significant reduction (27%) in the plasma cortisol response to a 6-hour infusion of ACTH compared with placebo (+1%). The corresponding effect of 10 mg prednisone daily was a 35% reduction in the plasma cortisol response to ACTH. Formoterol An overdose of formoterol would likely lead to an exaggeration of effects that are typical for beta 2 ‑agonists: seizures, angina, hypertension, hypotension, tachycardia, atrial and ventricular tachyarrhythmias, nervousness, headache, tremor, palpitations, muscle cramps, nausea, dizziness, sleep disturbances, metabolic acidosis, hyperglycemia, hypokalemia. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of formoterol. No clinically significant adverse reactions were seen when formoterol was delivered to adult patients with acute bronchoconstriction at a dose of 90 mcg/day over 3 hours or to stable asthmatics 3 times a day at a total dose of 54 mcg/day for 3 days. Treatment of formoterol overdosage consists of discontinuation of the medication together with institution of appropriate symptomatic and/or supportive 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 formoterol. Cardiac monitoring is recommended in cases of overdosage.

11 DESCRIPTION

DESCRIPTION SECTION

BREYNA 80 mcg/4.5 mcg and BREYNA 160 mcg/4.5 mcg each contain micronized budesonide and micronized formoterol fumarate dihydrate for oral inhalation only. Each BREYNA 80 mcg/4.5 mcg and BREYNA 160 mcg/4.5 mcg canister is formulated as a hydrofluoroalkane (HFA 227; 1,1,1,2,3,3,3-heptafluoropropane)-propelled pressurized metered dose inhaler containing 120 actuations [see Dosage Forms and Strengths (3) and How Supplied/Storage and Handling (16) ] . After priming, each actuation meters either 91/5.1 mcg or 181/5.1 mcg from the valve and delivers either 80/4.5 mcg, or 160/4.5 mcg (budesonide micronized/formoterol fumarate dihydrate micronized) from the actuator. The actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between actuation of the device and inspiration through the delivery system. BREYNA also contains povidone K25 USP as a suspending agent and polyethylene glycol 1000 NF as a lubricant. BREYNA should be primed before using for the first time by releasing two test sprays into the air away from the face, shaking well for 5 seconds before each spray. In cases where the inhaler has not been used for more than 7 days or when it has been dropped, prime the inhaler again by shaking well for 5 seconds before each spray and releasing two test sprays into the air away from the face. One active component of BREYNA is budesonide, a corticosteroid designated chemically as (RS)‑11β, 16α, 17,21-Tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C 25 H 34 O 6 and its molecular weight is 430.5. Its structural formula is: Budesonide is a white to off-white, tasteless, odorless powder which is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 7.4 is 1.6 x 10 3 . The other active component of BREYNA is formoterol fumarate dihydrate, a selective beta 2 -agonist designated chemically as (R*,R*)-(±)-N-[2-hydroxy-5-[1-hydroxy-2-[[2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]formamide, (E)-2-butendioate(2:1), dihydrate. The empirical formula of formoterol is C 42 H 56 N 4 O 14 and its molecular weight is 840.9. Its structural formula is: Formoterol fumarate dihydrate is a powder which is slightly soluble in water. Its octanol-water partition coefficient at pH 7.4 is 2.6. The pKa of formoterol fumarate dihydrate at 25°C is 7.9 for the phenolic group and 9.2 for the amino group.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

BREYNA (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol is available in two strengths and is supplied in the following package sizes: Dosage Forms and Strengths Package Size NDC BREYNA Inhalations 80 mcg/4.5 mcg 120 0378-7502-32 BREYNA Inhalations 160 mcg/4.5 mcg 120 0378-7503-32 Each strength is supplied as a pressurized aluminum canister with an attached counting device, a blue plastic actuator body with a blue mouthpiece, and attached grey dust cap. Each 120 inhalation canister has a net fill weight of 10.3 grams. Each canister is packaged in a foil overwrap pouch with desiccant sachet and placed into a carton. Each carton contains one canister and a Patient Information leaflet. The BREYNA canister should only be used with the BREYNA actuator, and the BREYNA actuator should not be used with any other inhalation drug product. The correct amount of medication in each inhalation cannot be ensured after the labeled number of inhalations from the canister have been used, even though the inhaler may not feel completely empty and may continue to operate. The inhaler should be discarded when the labeled number of inhalations have been used or within 3 months after removal from the foil pouch. Never immerse the canister into water to determine the amount remaining in the canister (“float test”). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store the inhaler with the mouthpiece down. For best results, the canister should be at room temperature before use. Shake well for 5 seconds before using. Keep out of the reach of children. Avoid spraying in eyes. CONTENTS UNDER PRESSURE. Do not puncture or incinerate. Do not store near heat or open flame. Exposure to temperatures over 120ºF may cause bursting. Never throw container into fire or incinerator.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Serious Asthma-Related Events: Inform patients with asthma that LABA when used alone increases the risk of asthma-related hospitalization or asthma-related death. Available data show that when ICS and LABA are used together, such as with BREYNA, there is not a significant increase in risk of these events. Not for Acute Symptoms: Inform patients that BREYNA is not meant to relieve acute symptoms of asthma or COPD and extra doses should not be used for that purpose. Advise patients to treat acute symptoms with an inhaled, short-acting beta 2 -agonist such as albuterol. Provide patients with such medication and instruct the patient in how it should be used. Instruct patients to seek medical attention immediately if they experience any of the following: • Decreasing effectiveness of inhaled, short-acting beta 2 -agonists • Need for more inhalations than usual of inhaled, short-acting beta 2 -agonists • Significant decrease in lung function as outlined by the physician Tell patients they should not stop therapy with BREYNA without physician/provider guidance since symptoms may recur after discontinuation. Do Not Use Additional Long-Acting Beta 2 -Agonists: Instruct patients not to use other LABA for asthma and COPD. Local Effects: Inform patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with BREYNA, but at times therapy with BREYNA may need to be temporarily interrupted under close medical supervision. Rinsing the mouth with water without swallowing after inhalation is advised to reduce the risk of thrush. Pneumonia: Patients with COPD have a higher risk of pneumonia; instruct them to contact their healthcare provider if they develop symptoms of pneumonia. Immunosuppression: Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chicken pox or measles and, if exposed, to consult their physician without delay. Inform patients of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex. Hypercorticism and Adrenal Suppression: Advise patients that BREYNA may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to BREYNA. Reduction in Bone Mineral Density: Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk. Reduced Growth Velocity: Inform patients that orally inhaled corticosteroids, a component of BREYNA, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of children and adolescents taking corticosteroids by any route. Ocular Effects: Long-term use of inhaled corticosteroids may increase the risk of some eye problems (cataracts or glaucoma); consider regular eye examinations. Risks Associated with Beta-Agonist Therapy: Inform patients of adverse effects associated with beta 2 -agonists, such as palpitations, chest pain, rapid heart rate, tremor, or nervousness. BREYNA is a registered trademark of Mylan Pharmaceuticals Inc., a Viatris Company. © 2025 Viatris Inc. Distributed by: Mylan Pharmaceuticals Inc., a Viatris Company Morgantown, WV 26505 U.S.A. Revised: 11/2025 KD:BUFOIA:R3 3200001786

Patient Information

SPL PATIENT PACKAGE INSERT SECTION

BREYNA (brehy-nah) (budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg) Inhalation Aerosol BREYNA (brehy-nah) (budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg) Inhalation Aerosol What is BREYNA? BREYNA combines an inhaled corticosteroid medicine (ICS), budesonide and a long-acting beta 2 -adrenergic agonist (LABA) medicine, formoterol. • Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems. • LABA medicines are used in people with chronic obstructive pulmonary disease (COPD) and asthma. LABA medicines help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe. In severe cases, wheezing can stop your breathing and may lead to death if not treated right away. BREYNA is not used to relieve sudden breathing problems and will not replace a rescue inhaler. BREYNA is used for asthma and COPD as follows: • Asthma: BREYNA is used to control symptoms of asthma, and prevent symptoms such as wheezing in adults and children ages 6 and older. BREYNA contains formoterol. LABA medicines such as formoterol when used alone increase the risk of death and hospitalizations from asthma problems. BREYNA contains an ICS and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems. BREYNA is not for adults and children with asthma who are well controlled with an asthma-control medicine, such as a low to medium dose of an ICS. BREYNA is for adults and children with asthma who need both an ICS and LABA medicine. It is not known if BREYNA is safe and effective in children less than 6 years of age with asthma. • COPD: COPD is a long-term (chronic) lung disease that includes chronic bronchitis, emphysema, or both. BREYNA 160 mcg/4.5 mcg is used long-term, as 2 inhalations 2 times each day, to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days). Do not use BREYNA: • to treat sudden severe symptoms of asthma or COPD. • if you are allergic to any of the ingredients in BREYNA. See the end of this leaflet for a list of ingredients in BREYNA. Before you use BREYNA, tell your healthcare provider about all of your medical conditions, including if you: • have heart problems. • have high blood pressure. • have seizures. • have thyroid problems. • have diabetes. • have liver problems. • have osteoporosis. • have an immune system problem. • have eye problems such as increased pressure in the eye, glaucoma, or cataracts. • are allergic to any medicines. • have any type of viral, bacterial, fungal, or parasitic infection. • are exposed to chicken pox or measles. • are pregnant or plan to become pregnant. It is not known if BREYNA may harm your unborn baby. • are breastfeeding. Budesonide, one of the active ingredients in BREYNA, passes into breast milk. You and your healthcare provider should decide if you will take BREYNA while breastfeeding. Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. BREYNA and certain other medicines may interact with each other. This may cause serious side effects. Especially tell your healthcare provider if you take antifungal or anti-HIV medicines. Know all the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine. How should I use BREYNA? See the step-by-step instructions for using BREYNA at the end of this Patient Information leaflet. Do not use BREYNA unless your healthcare provider has taught you and you understand everything. Ask your healthcare provider or pharmacist if you have any questions. • Use BREYNA exactly as prescribed. Do not use BREYNA more often than prescribed. BREYNA comes in 2 strengths. Your healthcare provider has prescribed the strength that is best for you. Note the differences between BREYNA and your other inhaled medications, including the differences in prescribed use and physical appearance. • Children should use BREYNA with an adult’s help, as instructed by the child’s healthcare provider. • BREYNA should be taken every day as 2 puffs in the morning and 2 puffs in the evening about 12 hours apart. • If you miss a dose of BREYNA, you should take your next dose at the same time you normally do. • Rinse your mouth with water and spit the water out after each dose (2 puffs) of BREYNA. Do not swallow the water. This will help to lessen the chance of getting a fungus infection (thrush) in the mouth and throat. • If you take too much BREYNA, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness. • Do not spray BREYNA in your eyes. If you accidentally get BREYNA in your eyes, rinse your eyes with water, and if redness or irritation persists, consult your healthcare provider. • Do not change or stop any medicines used to control or treat your breathing problems. Your healthcare provider will change your medicines as needed. • While you are using BREYNA 2 times each day, do not use other medicines that contain a LABA for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines. • BREYNA does not relieve sudden symptoms. Always have a rescue inhaler medicine with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you. • Call your healthcare provider or get medical care right away if: o your breathing problems worsen with BREYNA. o you need to use your rescue inhaler medicine more often than usual. o your rescue inhaler medicine does not work as well for you at relieving symptoms. o your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you. o your symptoms do not improve after using BREYNA regularly for 1 week. What are the possible side effects of BREYNA? BREYNA may cause serious side effects, including: • Using too much of a LABA medicine may cause: o chest pain o a fast and irregular heartbeat o tremor o increased blood pressure o headache o nervousness • Fungal infection in your mouth or throat (thrush) . Rinse your mouth with water without swallowing after using BREYNA to help reduce your chance of getting thrush. • Pneumonia and other lower respiratory tract infections. People with COPD have a higher chance of getting pneumonia and other lung infections. Inhaled corticosteroids may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of these symptoms: o increase in mucus (sputum) production o fever o increased cough • change in mucus color • chills • increased breathing problems • Immune system effects and a higher chance for infections. Tell your healthcare provider about any signs of infection such as: o fever o body aches o feeling tired o vomiting o pain o chills o nausea • Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicine. • Increased wheezing right after taking BREYNA. Always have a rescue inhaler with you to treat sudden wheezing. • Serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction. • Lower bone mineral density. This can happen in people who have a high chance for low bone mineral density (osteoporos...

Instructions for Use

INSTRUCTIONS FOR USE SECTION

BREYNA (brehy-nah) (budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg) Inhalation Aerosol BREYNA (brehy-nah) (budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg) Inhalation Aerosol Figure 1 Upright Position How to Use BREYNA Follow the instructions below for using BREYNA. You will breathe-in (inhale) the medicine. If you have any questions, ask your doctor or pharmacist. Preparing your BREYNA inhaler for use 1. Take your BREYNA out of the moisture-protective foil pouch before you use it for the first time and throw the foil away. Write the date that you open the foil pouch on the box. 2. The inhaler comes with a counter (see Figure 1). The counter will count down each time you release a puff of BREYNA. The counter will show the number of inhalations (puffs) left in the canister. The counter will stop counting at zero (“0”). 3. Use the BREYNA canister only with the blue BREYNA inhaler supplied with the product. Parts of the BREYNA inhaler should not be used with parts from any other inhalation product. 4. Shake your BREYNA inhaler well for 5 seconds right before each use. Remove the mouthpiece cover by squeezing gently at both sides, then pulling out (see Figure 2). Check the mouthpiece for foreign objects before use. Figure 2 5. Priming your BREYNA inhaler Before you use BREYNA for the first time, you will need to prime it. To prime BREYNA, hold it in the upright position (see Figure 1). Shake the BREYNA inhaler well for 5 seconds. Hold your BREYNA inhaler facing away from you and press down the top of the canister firmly until fully depressed to release a test spray. Then shake it again for 5 seconds and release a second test spray. Your BREYNA inhaler is now primed and ready for use. After you have primed the BREYNA inhaler for the first time, the counter will read 120. If you do not use your BREYNA inhaler for more than 7 days or if you drop it, you will need to prime again. Ways to hold the BREYNA inhaler for use Figure 3 or Figure 4 Using your BREYNA inhaler 6. Shake your BREYNA inhaler well for 5 seconds. Remove the mouthpiece cover. Check the mouthpiece for foreign objects. 7. Breathe out fully (exhale). Hold the BREYNA inhaler up to your mouth. Place the blue mouthpiece fully into your mouth and close your lips around it. Make sure that the BREYNA inhaler is upright and that the opening of the mouthpiece is pointing towards the back of your throat (see Figure 5). Figure 5 8. Breathe in (inhale) deeply and slowly through your mouth. Press down the top of the canister firmly until fully depressed to release the medicine (see Figure 6). Figure 6 9. Continue to breathe in (inhale) and hold your breath for about 10 seconds, or for as long as is comfortable. Before you breathe out (exhale), release your finger from the top of the canister. Keep the BREYNA inhaler upright and remove from your mouth. 10. Shake the BREYNA inhaler again for 5 seconds and repeat steps 7 to 9. After using your BREYNA inhaler 11. After use, close the mouthpiece cover by pushing until it clicks in place. 12. After you finish taking BREYNA (2 puffs), rinse your mouth with water. Spit out the water. Do not swallow it. Reading the counter • The counter shows the number of inhalations (puffs) left in your inhaler. Counter • The counter will count down each time you release a puff of medicine (either when priming your BREYNA inhaler or when taking the medicine). • When the counter reads 20, it is time to call your healthcare provider for a refill. • It is important that you pay attention to the number of inhalations (puffs) left in your BREYNA inhaler by reading the counter. Throw away BREYNA when the counter shows zero (“0”) or 3 months after you take your BREYNA inhaler out of its foil pouch, whichever comes first. Your BREYNA inhaler may not feel empty and it may continue to operate, but you will not get the right amount of medicine if you keep using it. Use a new BREYNA inhaler and follow the instructions for priming (see instruction 5 above). How to clean your BREYNA inhaler Clean the blue mouthpiece of your BREYNA inhaler every 7 days. To clean the mouthpiece: • Remove the grey mouthpiece cover • Wipe the inside and outside of the blue mouthpiece opening with a clean, dry cloth • Replace the mouthpiece cover • Do not put the BREYNA inhaler into water • Do not try to take apart your BREYNA inhaler Distributed by: Mylan Pharmaceuticals Inc., a Viatris Company, Morgantown, WV 26505 U.S.A. This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration. BREYNA is a registered trademark of Mylan Pharmaceuticals Inc., a Viatris Company. © 2025 Viatris Inc. Revised: 11/2025 KD:IFU:BUFOIA:R3 3200001787

PRINCIPAL DISPLAY PANEL – 80 mcg/4.5 mcg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0378-7502-32 Rx only STORE UPRIGHT Breyna ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol 80 mcg/4.5 mcg FOR ORAL INHALATION ONLY 120 Inhalations Important: Please read accompanying Patient Information and Instructions for Use carefully prior to using. Contents: Each carton contains one canister. Net fill weight 10.3 g providing 120 inhalations. Each actuation delivers 80 mcg of budesonide and 4.5 mcg of formoterol fumarate dihydrate. Inactive ingredients include povidone K25, polyethylene glycol 1000, and HFA 227. Dosage: Use only as directed by Physician. Warning: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F. Keep out of the reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store the inhaler with the mouthpiece down. Shake inhaler well for 5 seconds before using. Discard within three months after removing from foil pouch. For oral inhalation with BREYNA inhaler only. Use this device for BREYNA only. Date foil pouch opened: ________ Discard the inhaler when the labeled number of inhalations have been used or within 3 months of opening the foil pouch. Don’t Forget to Take Daily www.VIATRIS.com Distributed by: Mylan Pharmaceuticals Inc., a Viatris Company Morgantown, WV 26505, U.S.A. BREYNA is a registered trademark of Mylan Pharmaceuticals Inc., a Viatris Company. © 2025 Viatris Inc. KD:7502:1C:R2 3200001785

PRINCIPAL DISPLAY PANEL – 160 mcg/4.5 mcg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0378-7503-32 Rx only STORE UPRIGHT Breyna ® (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol 160 mcg/4.5 mcg FOR ORAL INHALATION ONLY 120 Inhalations Important: Please read accompanying Patient Information and Instructions for Use carefully prior to using. Contents: Each carton contains one canister. Net fill weight 10.3 g providing 120 inhalations. Each actuation delivers 160 mcg of budesonide and 4.5 mcg of formoterol fumarate dihydrate. Inactive ingredients include povidone K25, polyethylene glycol 1000, and HFA 227. Dosage: Use only as directed by Physician. Warning: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F. Keep out of the reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store the inhaler with the mouthpiece down. Shake inhaler well for 5 seconds before using. Discard within three months after removing from foil pouch. For oral inhalation with BREYNA inhaler only. Use this device for BREYNA only. Date foil pouch opened: ________ Discard the inhaler when the labeled number of inhalations have been used or within 3 months of opening the foil pouch. Don’t Forget to Take Daily www.VIATRIS.com Distributed by: Mylan Pharmaceuticals Inc., a Viatris Company Morgantown, WV 26505, U.S.A. BREYNA is a registered trademark of Mylan Pharmaceuticals Inc., a Viatris Company. © 2025 Viatris Inc. KD:7503:1C:R2 3200001790