Zyflo Tablet
Product Images NDC 10122-901

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Zyflo (NDC 10122-901). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Chiesi Usa, 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

Zileuton (Zyflo 1)

Chemical structure of zileuton, the active ingredient in ZYFLO 600 mg oral tablets by Chiesi USA, Inc. The diagram shows the molecular arrangement including sulfur and nitrogen atoms associated with the zileuton molecule.*

FDA Label Image

Mean Change From Baseline To End Of Study (Zyflo 2)

A data table titled 'Mean Change from Baseline to End of Study' summarizing efficacy endpoints for ZYFLO 600 mg taken 4 times/day versus placebo over a six-month study. The table lists clinical measurements such as trough FEV1, AM and PM PEFR, beta-agonist use, daily symptom score, and nocturnal symptom score with numerical results for both treatment and placebo groups.*

FDA Label Image

Mean Change From Baseline To Trough Fev1 (l) (Zyflo 3)

A line graph titled 'Mean Change From Baseline To Trough FEV1 (L)' showing changes in lung function over 25 weeks. The x-axis represents weeks, and the y-axis shows mean change from baseline in liters. Two data series are shown: ZYFLO 600 mg four times daily (solid line with squares) and placebo (dashed line with circles), with statistical significance noted at several time points.*

FDA Label Image

Proportion Of Patients Experiencing Adverse Events In Placebo-controlled Studies In Asthma (Zyflo 4)

Data table presenting the proportion of patients experiencing adverse events in placebo-controlled asthma studies comparing ZYFLO 600 mg (4 times daily) and placebo. The table lists events by body system, including headache, abdominal pain, dyspepsia, nausea, and myalgia, with respective occurrence percentages for both treatment groups.*

FDA Label Image

Zyflo Bottle (Zyflo 5)

ZYFLO zileuton tablets 600 mg oral dosage form label containing 120 tablets. The label includes the proprietary name Zyflo, generic name zileuton, strength 600 mg, package count of 120 tablets, and the labeler Chiesi USA, Inc. The label also displays the NDC number 10122-901-12 and states Rx only for prescription use.*

* 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.