Singulair
Product Images NDC 68258-3032

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Singulair (NDC 68258-3032). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Dispensing Solutions 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

Chemical Structure (1978bde5 271a 493c B2ed 0349051a6a42 01)

Chemical structure diagram showing the molecular formula of the active ingredient in SINGULAIR. The structure includes several aromatic rings, a chlorine atom, and a sodium carboxylate group, representing the composition of montelukast sodium.*

FDA Label Image

Figure 1 (1978bde5 271a 493c B2ed 0349051a6a42 02)

A line graph comparing mean percent change from baseline over weeks in treatment between Placebo and SINGULAIR groups. The x-axis represents weeks in treatment up to 15 weeks, and the y-axis shows percent change. The graph depicts an upward trend for both groups initially, with SINGULAIR showing a greater increase compared to Placebo.*

FDA Label Image

Figure 2 (1978bde5 271a 493c B2ed 0349051a6a42 03)

A line graph comparing mean percent changes from baseline over weeks in treatment and washout periods for SINGULAIR, placebo, and desloratadine. The x-axis represents weeks in treatment and washout, while the y-axis shows mean percent change from baseline.*

FDA Label Image

Figure 3 (1978bde5 271a 493c B2ed 0349051a6a42 04)

A bar graph comparing the percent change from baseline in FEV1 for patients taking SINGULAIR versus those taking beclomethasone. The x-axis shows ranges of percent change from baseline, and the y-axis shows the percent of patients in each range. Bars indicate the distribution of patient responses for both treatments.*

FDA Label Image

Figure 4 (1978bde5 271a 493c B2ed 0349051a6a42 05)

A line chart illustrating the change in height (cm) over weeks on treatment comparing SINGULAIR 5 mg, Beclomethasone 336 mcg, and placebo groups. The x-axis represents weeks on treatment, ranging from -20 to 60, and the y-axis shows change in height from -1 to 7 cm. The graph highlights treatment effects with mean height changes over time.*

FDA Label Image

Chewable Tablets (Bottle Label)

SINGULAIR 5 mg chewable tablets label showing the product name, dosage strength, and tablet count of 30. The label states the active ingredient as montelukast sodium equivalent to 5 mg montelukast, with a note for pediatric patients aged 6-14 years. It includes directions to chew and swallow as directed by a physician, lot and expiration information marked as sample, NDC 68258-3032-03, and the labeler Dispensing Solutions Inc. The label also contains warnings about storing at 77°F and keeping out of children's reach.*

FDA Label Image

Tablets (Bottle Label)

Pharmaceutical label for SINGULAIR 10 mg tablets, showing a count of 30 tablets. The label indicates the active ingredient is montelukast sodium equivalent to 10 mg montelukast per tablet. It includes manufacturer details with Merck & Co., Inc. as the distributor and Dispensing Solutions Inc. as the packager. Additional information includes storage instructions at 77°F, prescription-only status, and patient usage directions advising to take the tablets orally as directed by a physician.*

* 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.