Dulera Aerosol
Product Images NDC 78206-127

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Dulera (NDC 78206-127). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Organon Llc, 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

Image Of Mometasone Furoate Chemical Structure (Dulera 01)

Chemical structure diagram of mometasone furoate, an active ingredient in Dulera. The diagram displays the molecular framework with various chemical groups and bonds shown.*

FDA Label Image

Image Of Formoterol Fumarate Dihydrate Chemical Structure (Dulera 02)

Chemical structure of mometasone furoate and formoterol fumarate dihydrate, the active ingredients in Dulera inhalation aerosol. The image depicts molecular diagrams with labeled functional groups and stereochemistry as presented in the product labeling.*

FDA Label Image

Image Of Figure 1 (Dulera 03)

A line graph depicting the change from baseline FEV1 (liters) over 12 hours relative to AM dosing in a clinical study. It compares the mean FEV1 response at week 12 for Dulera 100 mcg/5 mcg (N=166), formoterol fumarate 5 mcg (N=135), mometasone furoate 100 mcg (N=169), and placebo (N=128). The graph shows time on the x-axis (hours 0 to 12) and change in FEV1 on the y-axis.*

FDA Label Image

Figure 2 (Dulera 03a)

A line graph depicting study visit data over time from baseline through week 12. The graph compares two treatments: MF MDI 50 mcg and MF/F MDI 50/5 mcg, showing changes in LS Mean values. The x-axis represents study visits, and the y-axis shows the LS Mean values with respective trends for each treatment.*

FDA Label Image

Image Of Figure 1 (Dulera 04)

Illustration of a Dulera inhaler device showing labeled parts including the dose counter, canister, blue actuator, and the blue mouthpiece with a green cap. This respiratory aerosol is used for administration of mometasone furoate and formoterol fumarate dihydrate.*

FDA Label Image

Image Of Figure 2 (Dulera 05)

An instructional illustration showing proper handling of an inhaler for Dulera aerosol. It depicts a hand holding the inhaler upright, with arrows pointing to the blue mouthpiece and the green cap being removed.*

FDA Label Image

Image Of Figure 3 (Dulera 06)

Instructional illustration showing a person removing the protective cap from a Dulera inhaler aerosol device for respiratory inhalation use. The image demonstrates the first step in preparing the inhaler for administration.*

FDA Label Image

Image Of Figure 4 (Dulera 07)

Instructional illustration featuring a woman demonstrating the use of an inhaler for oral inhalation. The image shows the woman holding the inhaler to her mouth and a close-up of the inhaler device itself, emphasizing proper inhaler use for respiratory medication.*

FDA Label Image

Image Of Figure 5 (Dulera 08)

An instructional illustration showing hands holding a Dulera respiratory aerosol inhaler. One hand is gripping the inhaler while the other hand is removing the protective cap, with an arrow indicating the direction to remove the cap.*

FDA Label Image

Image Of Dose Counter (Dulera 09)

Close-up images of dose counters on Dulera aerosol inhalers showing counts of 60 and 120 doses remaining. The inhaler is used for respiratory delivery of mometasone furoate and formoterol fumarate dihydrate by Organon LLC.*

FDA Label Image

Principal Display Panel (100 mcg/5 mcg Canister Carton)

Dulera 100 mcg/5 mcg per actuation inhalation aerosol packaging label. The label includes the proprietary name Dulera, the active ingredients mometasone furoate and formoterol fumarate dihydrate, and the dosage strength 100 mcg/5 mcg per actuation. The label shows 120 metered actuations, instructions to shake well before using, and storage conditions at controlled room temperature. The product is manufactured for Organon LLC and includes warnings and barcode information.*

FDA Label Image

Principal Display Panel (200 mcg/5 mcg Canister Carton)

Packaging label for Dulera 200 mcg/5 mcg inhalation aerosol, containing mometasone furoate and formoterol fumarate dihydrate. The label displays the brand name Dulera prominently, with strength and dosing form noted. It includes usage instructions such as 'Shake well before using,' storage conditions, manufacturer information (Organon LLC), and safety warnings. The label also shows barcodes and serialization space, indicating a 120 metered actuation canister.*

FDA Label Image

Principal Display Panel (50 mcg/5 mcg Canister Carton)

Dulera 50 mcg/5 mcg inhalation aerosol carton label with prescribing information highlights. Manufactured by Organon LLC, the label shows the dosage strength and formoterol fumarate dihydrate and mometasone furoate as active ingredients. The packaging includes storage instructions, cautionary statements, and barcode for scanning. Contains 120 metered actuations.*

* 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.