Budesonide And Formoterol Fumarate Dihydrate Aerosol, Metered
Product Images NDC 0480-3080

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Budesonide And Formoterol Fumarate Dihydrate (NDC 0480-3080). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Teva 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.

FDA Label Image

1 (Image 1)

FDA Label Image

1 (Image 10)

This is a description of a canister with an actuator, dose indicator, mouthpiece, and mouthpiece cover shown in an upright position in Figure 1.*

FDA Label Image

2 (Image 11)

FDA Label Image

34 (Image 12)

FDA Label Image

5 (Image 13)

FDA Label Image

1 (Image 14)

FDA Label Image

1 (Image 15)

This text appears to be related to a pharmaceutical product, specifically an inhalation aerosol containing Budesonide and Formoterol Fumarate Dihydrate. It mentions instructions for use, dosage information, and guidance for pharmacists on dispensing to patients. The product seems to be intended for oral inhalation only, with 120 inhalations per device. It also alludes to patient information leaflets accompanying the product.*

FDA Label Image

1 (Image 16)

This is a product label for Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol, containing 160 mcg/4.5 mcg per dose. It is intended for oral inhalation only. The label provides instructions for pharmacists to dispense the product and advises patients on dosage and proper usage. The product is for prescription-only use and comes with 120 inhalations. Remembering to take the prescribed doses is emphasized on the label, along with safety precautions and instructions for device maintenance.*

FDA Label Image

1 (Image 2)

FDA Label Image

1 (Image 3)

FDA Label Image

2 (Image 4)

This is a medication use record showing the dosages for Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol at 80/4 mcg and Budesonide alone at 80 mcg as well as Formoterol alone at 4.5 mcg. The administration is two inhalations twice daily for each. It also mentions a placebo.*

FDA Label Image

3 (Image 5)

This text presents data on the percent change from baseline in FEV1 over 12 hours. The measurements are provided for different time points and treatments, including Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol, Budesonide, Formoterol, Budesonide + Formoterol, and Placebo. The text indicates the hours observed and the dosages used for each treatment. These details can be used to evaluate the impact of the different treatments on FEV1 levels over time.*

FDA Label Image

4 (Image 6)

This text provides information on the percent change from baseline in Forced Expiratory Volume in one Second (FEV1) over a 12-hour period. It includes data for different time points and treatment groups for a study involving Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol. The study involves dosages of Budesonide 160 mcg, Formoterol 4.5 mcg, and a combination of both, with comparisons to a placebo group. The results show the FEV1 measurements at different time points.*

FDA Label Image

5 (Image 7)

This text provides information on the change in 1-hour post-dose FEV1 (L) for two different medications - Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 mcg and Budesonide 80 mcg. It lists the number of patients assessed at different time points (0, 1h, 2, 4, 6, 8, 10, 12) for each medication. The data includes numerical values representing the change from baseline in FEV1 for each time point.*

FDA Label Image

6 (Image 8)

FDA Label Image

7 (Image 9)

Description: The text provides information on a medication called Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol. It includes details on the dosage, with Budesonide at 160 mcg and Formoterol at 4.5 mcg. The text also mentions the percent change from baseline in 1-hour post-dose FEV. Additionally, it indicates the treatment plan with different dosages and mentions a placebo option.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.