Breyna Aerosol, Metered
Product Images NDC 0378-7503

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Breyna (NDC 0378-7503). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan Pharmaceuticals Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Budesonide Structural Formula (Image 01)

Chemical structure diagram of the active ingredients Budesonide and Formoterol Fumarate showing their molecular arrangements as part of the BREYNA inhalation aerosol product by Mylan Pharmaceuticals Inc.*

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Formoterol Fumarate Dihydrate Structrual Formula (Image 02)

Chemical structure of Budesonide and Formoterol Fumarate, shown with detailed molecular formula including functional groups and hydrate components as part of the compound.*

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Figure 1 Mean Percent Change From Baseline In Pre-dose Fev1 Over 12 Weeks (study 1) (Image 03)

A line graph showing percent change from baseline in predose FEV1 over 12 weeks, comparing different treatment groups for Budesonide/Formoterol. The x-axis shows Weeks (0, 2, 6, 12) and the y-axis shows percent change in FEV1. Lines represent Budesonide/Formoterol 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, Budesonide 160 + Formoterol 4.5 mcg, and placebo, each given as two inhalations twice daily. Data points with corresponding participant counts at each time point are included in the graph's legend.*

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Figure 2 Mean Percent Change From Baseline In Pre-dose Fev1 Over 12 Weeks (study 2) (Image 04)

A line graph showing percent change from baseline in predose FEV1 over a 12-week period for four treatment groups: Budesonide/Formoterol 80/4.5 mcg, Budesonide 80 mcg, Formoterol 4.5 mcg, and placebo. The graph includes data point markers and a legend explaining the treatments and dosing frequency of two inhalations twice daily. Sample sizes at various weeks are listed below the chart.*

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Figure 3 Mean Percent Change From Baseline In Fev1 On Day Of Randomization (study 1) (Image 05)

A line graph illustrating percent change from baseline in FEV1 over 12 hours for different treatments including Budesonide/Formoterol 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, a combination of Budesonide 160 mcg + Formoterol 4.5 mcg, and placebo. The x-axis represents hours from 0 to 12, and the y-axis shows percent change from -10 to 25.*

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Figure 4 Mean Percent Change From Baseline In Fev1 At End Of Treatment (study 1) (Image 06)

A line graph showing the percent change from baseline in FEV1 over 12 hours for different treatments including Budesonide/Formoterol 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, Budesonide/Formoterol combined, and placebo. The x-axis represents hours post-dose, and the y-axis displays percent change from baseline in FEV1. The graph compares pulmonary function response over time following two inhalations twice daily dosing regimens.*

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Figure 5 Change From Baseline In Clinic-measured 1-hour Post-dose Fev1 Over 12 Weeks (efficacy And Safety Study In Patients 6 To Less Than 12 Years Of Age) (Image 07)

Line graph depicting change from baseline in 1-hour post-dose FEV1 (L) over 12 weeks comparing Budesonide/Formoterol 80/4.5 mcg and Budesonide 80 mcg, both administered as two inhalations twice daily. The graph includes patient counts at various assessments and shows treatment comparisons over time.*

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Figure 6 Mean Percent Change From Baseline In Pre-dose Fev1 Over 6 Months (study 1) (Image 08)

A line graph showing percent change from baseline in pre-dose FEV1 over six months of treatment for different drug groups including Budesonide/Formoterol MDI 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, Budesonide 160 + Formoterol 4.5 mcg, and Placebo. The graph depicts the comparative lung function response for these treatments over time.*

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Figure 7 Mean Percent Change From Baseline In 1-hour Post-dose Fev1 Over 6 Months (study 1) (Image 09)

A line graph showing the percent change from baseline in 1-hour post-dose FEV1 over a 6-month period for different treatment groups: Budesonide/Formoterol MDI 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, Budesonide 160 mcg plus Formoterol 4.5 mcg, and placebo. The graph includes data points at months 0, 1, 2, 4, and 6 with a numerical table of sample sizes below the x-axis.*

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Instructions For Use Figure 1 (Image 10)

An instructional illustration depicting the parts of a BREYNA (budesonide and formoterol fumarate) metered dose inhaler. The labeled components include the canister, inhaler body, mouthpiece, mouthpiece cover, and dose counter.*

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Instructions For Use Figure 2 (Image 11)

Illustration depicting a hand holding a BREYNA inhaler and another hand removing the protective cap from the mouthpiece, demonstrating the preparation for use of the aerosol metered inhaler.*

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Instructions For Use Figure 3 (Image 12)

An instructional illustration showing a hand holding and activating a blue metered-dose inhaler, with medication spraying from the device's nozzle. The image depicts proper use of the inhaler for respiratory medication delivery.*

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Instructions For Use Figure 4 (Image 13)

An instructional illustration showing a person holding a blue metered dose inhaler above their open palm, with medication being released from the inhaler nozzle into the hand. The image demonstrates how to properly deliver a dose of aerosol medication from the inhaler device.*

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Instructions For Use Figure 5 (Image 14)

An illustration showing the proper use of an aerosol metered inhaler representing Breyna (Budesonide and Formoterol Fumarate). It depicts a person holding the inhaler upright and bringing it to their mouth for inhalation, demonstrating the respiratory administration route.*

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Instructions For Use Counter Image 01 (Image 15)

The image shows a close-up of the top of a BREYNA aerosol metered inhaler canister. The top surface is blue with a circular dose counter window displaying the number '120' in white on a black background. The inhaler is used for respiratory administration of Budesonide and Formoterol Fumarate, marketed by Mylan Pharmaceuticals Inc.*

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Instructions For Use Counter Image 02 (Image 16)

Illustration showing a close-up view of a blue metered dose inhaler canister with a black circular dose counter displaying the number 119 on its top side.*

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Instructions For Use Counter Image 03 (Image 17)

Close-up image of a blue BREYNA metered aerosol inhaler showing the dose counter reading "20". BREYNA contains Budesonide and Formoterol Fumarate and is manufactured by Mylan Pharmaceuticals Inc.*

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Breyna Inhalation Aerosol 80 Mcg/4.5 Mcg Carton (Image 18)

Box packaging label for Breyna inhalation aerosol by Mylan Pharmaceuticals Inc. It contains budesonide and formoterol fumarate dihydrate at a strength of 80 mcg/4.5 mcg per inhalation. The box indicates 120 inhalations per canister and is labeled for oral inhalation only. The design includes dosage instructions, storage conditions, and safety warnings, with the Mylan logo and barcode visible.*

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Breyna Inhalation Aerosol 160 Mcg/4.5 Mcg Carton (Image 19)

Packaging label for BREYNA 160 mcg/4.5 mcg aerosol metered inhalation. Contains budesonide and formoterol fumarate dihydrate for oral inhalation. The carton states 120 inhalations per canister and is labeled with the Mylan Pharmaceuticals Inc. logo. The label includes storage instructions, dosage warnings, and a barcode.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.