Symbicort Aerosol
Product Images NDC 50090-4509

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Symbicort (NDC 50090-4509). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by A-s Medication Solutions, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure 1 (Figure1bodytext)

A line graph depicting percent change from baseline in predicted FEV1 over 12 weeks for different treatments, including SYMBICORT 160/4.5 mcg (two inhalations twice daily), Budesonide 160 mcg (two inhalations twice daily), Formoterol 4.5 mcg (two inhalations twice daily), Budesonide 160 mcg plus Formoterol 4.5 mcg (two inhalations twice daily), and placebo. Data points are shown at multiple weeks with a legend and sample sizes at each time point.*

FDA Label Image

Figure 2 (Figure2bodytext)

A line graph showing the percent change from baseline in predose FEV1 over 12 weeks for multiple treatments: SYMBICORT 80/4.5 mcg (two inhalations twice daily), Budesonide 80 mcg (two inhalations twice daily), Formoterol 4.5 mcg (two inhalations twice daily), and placebo. The graph includes sample sizes at several time points and depicts the effectiveness of each treatment in improving lung function over time.*

FDA Label Image

Figure 3 (Figure3bodytext)

A line graph depicting percent change from baseline in FEV1 over 12 hours for different dosing regimens of SYMBICORT and its individual components. The x-axis represents time in hours from 0 to 12, and the y-axis shows percent change from baseline. Various symbols differentiate SYMBICORT 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, and their combination administered via two inhalations twice daily.*

FDA Label Image

Figure 4 (Figure4bodytext)

Line graph showing percent change from baseline in FEV1 over 12 hours for different treatment groups in a study, including SYMBICORT 160/4.5 mcg, Budesonide 160 mcg, Formoterol 4.5 mcg, Budesonide plus Formoterol combination, and placebo. The x-axis represents time in hours, and the y-axis represents percent change in FEV1.*

FDA Label Image

Figure 5 (Figure5bodytext)

A line chart showing change from baseline in 1-hour post-dose FEV1 (liters) over 12 weeks comparing SYMBICORT 80/4.5 mcg (two inhalations twice daily) and Budesonide 80 mcg (two inhalations twice daily). Data points at weeks 0, 1, 2, 4, 8, and 12 illustrate greater lung function improvement with SYMBICORT versus Budesonide. Patient numbers at each time point are also listed below the x-axis.*

FDA Label Image

Figure 6 (Figure6bodytext)

A line graph showing the percent change from baseline in pre-dose FEV1 over six months for different treatments: SYMBICORT MDI 160/4.5 mcg (two inhalations twice daily), Budesonide 160 mcg (two inhalations twice daily), Formoterol 4.5 mcg (two inhalations twice daily), Budesonide 160 mcg plus Formoterol 4.5 mcg (two inhalations twice daily), and placebo. The graph includes sample sizes at various months and labels for each treatment curve.*

FDA Label Image

Figure 7 (Figure7bodytext)

Line graph depicting percent change from baseline in 1-hour post-dose FEV1 over 6 months for SYMBICORT MDI 160/4.5 mcg, budesonide 160 mcg, formoterol 4.5 mcg, budesonide plus formoterol 4.5 mcg, and placebo, each administered as two inhalations twice daily. The x-axis shows time in months, and the y-axis shows percent change in FEV1. Treatment group sample sizes at each time point are listed below the graph.*

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Budesonide Structural Formula (Image 01)

Chemical structure diagram showing the molecular structures of the active ingredients in SYMBICORT: Budesonide and Formoterol Fumarate Dihydrate.*

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Structural Fumarate (Image 02)

Chemical structure diagram of Budesonide and Formoterol Fumarate Dihydrate, the active ingredients in SYMBICORT inhalation aerosol. The image shows detailed molecular components including the fumarate and dihydrate groups.*

FDA Label Image

Figure 1 (Image 03)

Illustration of a respiratory inhaler device labeled with parts including counter, canister inside, inhaler, mouthpiece, strap, and mouthpiece cover. The diagram shows the components of the device intended for delivering medication by inhalation.*

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Figure 2 (Image 04)

An instructional illustration showing a person removing the cap from a red aerosol inhaler device, identified as SYMBICORT. The figure demonstrates the proper way to grip the inhaler and pull off the mouthpiece cover by applying lateral force indicated by arrows.*

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Figure 3 (Image 05)

An instructional illustration showing a hand holding a Symbicort aerosol inhaler with the mouthpiece cap removed and sprayed, demonstrating proper usage by pressing down the canister to release the medication spray.*

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Figure 4 (Image 06)

An instructional diagram showing hands holding a Symbicort aerosol inhaler with the cap removed, demonstrating powdered medication being released from the inhaler onto a finger, labeled as Figure 4.*

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Figure 5 (Image 07)

An instructional illustration showing a person using a Symbicort aerosol inhaler by bringing the mouthpiece to their mouth and pressing the canister to release the medication for inhalation.*

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Counter (arrow pointing to 80)

An illustration showing a circular dial scale ranging from 0 to 120 with marked intervals at every 10 units. A pointer is positioned near 80, and shaded areas highlight the range between 0 to approximately 20. This diagram likely represents a dose counter or meter related to Symbicort aerosol inhaler usage.*

FDA Label Image

Counter (arrow pointing to 15)

An illustration resembling a circular gauge or dial ranging from 0 to 120 with shaded areas between 0 and 20, and a black pointer indicating approximately 25. The image does not contain any text related to the drug or its labeling.*

FDA Label Image

Label Image (Lbl500904509)

SYMBICORT 160/4.5 inhalation aerosol label from A-S Medication Solutions, LLC. Each actuation delivers 160 mcg budesonide and 4.5 mcg formoterol fumarate dihydrate. The label includes storage instructions to keep at 68 to 77 degrees Fahrenheit with the mouthpiece down. Package contains 120 inhalations.*

* 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.