Singulair Tablet, Chewable
Product Images NDC 78206-173

7 FDA label images from Organon Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Singulair (NDC 78206-173). 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 Figure 1 (Singulair 01)

Image Of Figure 1 (Singulair 01)
A line graph depicting change in height (cm) over weeks on treatment up to 56 weeks. It compares height changes among groups receiving SINGULAIR 5 mg, Beclomethasone 336 mcg, and Placebo, with data points marked for each group and lines showing growth trends over time.*
FDA Label Image

Image Of Montelukast Sodium Chemical Structure (Singulair 02)

Image Of Montelukast Sodium Chemical Structure (Singulair 02)
Chemical structure diagram of montelukast sodium, the active ingredient in SINGULAIR. The structure shows various atoms including chlorine, sulfur, and sodium arranged as per the molecular configuration of montelukast sodium.*
FDA Label Image

Image Of Figure 2 (Singulair 03)

Image Of Figure 2 (Singulair 03)
A line graph showing the mean percent change from baseline over weeks in treatment for SINGULAIR and placebo groups. The x-axis represents weeks in treatment up to week 15, including a washout period after week 12, and the y-axis shows the mean percent change from baseline. The SINGULAIR group shows a higher percent change compared to placebo throughout the treatment period.*
FDA Label Image

Principal Display Panel (4 mg Packet Carton)

Principal Display Panel (4 mg Packet Carton)
Packaging label for Singulair 4 mg oral granules containing montelukast sodium, labeled for pediatric patients 6 months to 5 years of age. The label indicates a 30-packet box distributed by Organon LLC. Storage instructions, barcode, and manufacturer information are included.*
FDA Label Image

Principal Display Panel (4 mg Tablet Bottle Label)

Principal Display Panel (4 mg Tablet Bottle Label)
Label for Singulair 4 mg chewable tablets containing montelukast sodium, indicated for pediatric patients aged 2-5 years. The label includes storage instructions, a warning for phenylketonurics, tablet count of 30, and is labeled by Organon LLC. An image of an oval pink tablet with imprint 'MSD 711' is shown.*
FDA Label Image

Principal Display Panel (5 mg Tablet Bottle Label)

Principal Display Panel (5 mg Tablet Bottle Label)
The image shows a label for Singulair chewable tablets containing montelukast sodium at a strength of 5 mg. The label specifies it is for pediatric patients aged 6 to 14 years with a package count of 30 tablets. The labeler is Organon LLC, and the label includes storage instructions, a barcode, and a small image of a pink round tablet marked 'MSD 275.' The label mentions the presence of phenylalanine and advises dispensing a medication guide with each patient.*
FDA Label Image

Principal Display Panel (10 mg Tablet Bottle Label)

Principal Display Panel (10 mg Tablet Bottle Label)
SINGULAIR 10 mg tablets label featuring montelukast sodium as the active ingredient. The label shows the Organon LLC logo and includes storage instructions, prescription only status, and a tablet image marked with 'MSD 117.' The package contains 30 tablets for oral administration, intended for adults 15 years and older.*

* 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.