Formoterol Fumarate Solution
Product Images NDC 0378-1631

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Formoterol Fumarate (NDC 0378-1631). 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.

FDA Label Image

Formoterol Fumarate Inhalation Solution 20 Mcg/2 mL Vial Carton Label (Image 01)

Carton label for Formoterol Fumarate Inhalation Solution 20 mcg/2 mL vial by Mylan Pharmaceuticals Inc. The label states it is for oral inhalation only and contains sterile unit-dose vials individually wrapped. The carton contains 30 vials. The label includes patient information notices and lists the active ingredient as formoterol fumarate USP with inactive ingredients such as citric acid, sodium citrate, sodium chloride, and water. The NDC number 0378-1631-93 is displayed.*

FDA Label Image

Formoterol Fumarate Structural Formula (Image 02)

Chemical structure of formoterol fumarate dihydrate, the active ingredient in FORMOTEROL FUMARATE inhalation solution. The structure shows the formoterol moiety complexed with fumaric acid and associated water molecules (dihydrate).*

FDA Label Image

Figure 1: Mean* Fev1 At Day 1 (Image 03)

A line graph comparing mean FEV1 in liters over 12 hours between Formoterol Fumarate Inhalation Solution 20 mcg and placebo groups. The x-axis represents time in hours, and the y-axis shows mean FEV1 values, illustrating higher lung function measurements in the formoterol group compared to placebo throughout the time period.*

FDA Label Image

Figure 2: Mean* Fev1 At Endpoint After 12 Weeks Of Treatment (Image 04)

A line graph depicting mean FEV1 (liters) over 12 hours comparing Formoterol Fumarate Inhalation Solution 20 mcg and placebo. The y-axis shows mean FEV1 in liters, ranging from 1.20 to 1.80, while the x-axis shows time in hours from 0 to 12. Data points indicate higher mean FEV1 values for the Formoterol Fumarate group compared to placebo throughout the 12-hour period.*

FDA Label Image

Instructions For Use Figure 1 (Image 05)

An instructional illustration showing a hand holding a device above another component, likely demonstrating how to assemble or prepare a respiratory inhalation solution device, specifically for Formoterol Fumarate inhalation solution 20 ug/2mL by Mylan Pharmaceuticals.*

FDA Label Image

Instructions For Use Figure 2 (Image 06)

An instructional line drawing showing a close-up of a formoterol fumarate dihydrate respiratory inhalation solution device. The image depicts a hand holding the inhaler, with an arrow indicating the insertion of a component into the inhaler's top section.*

FDA Label Image

Instructions For Use Figures 3 And 4 (Image 07)

Illustrations showing two methods of using a respiratory inhalation solution device. The left image depicts a person inhaling through the mouthpiece, and the right image shows a person inhaling through a facemask attached to the device. Both images highlight correct usage hand positioning on the inhaler.*

* 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.