Montelukast Sodium Tablet, Chewable
Product Images NDC 50268-574

6 FDA label images from Avpak · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 50268-574). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avpak, 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

Label 5026857315 Montelukast Sodium 2019 4mg

Label 5026857315 Montelukast Sodium 2019 4mg
Montelukast Sodium 4 mg chewable tablets label showing 50 tablets in unit dose packaging (5 x 10). The label states Rx only, pediatric use for ages 2-5 years, storage instructions, and manufacturer AvPAK, a product of AvKARE, Pulaski, TN. Contains barcode and dosing note indicating 4.2 mg equivalent per tablet.*
FDA Label Image

Label 5026857415 Montelukast Sodium 2019 5mg

Label 5026857415 Montelukast Sodium 2019 5mg
Montelukast Sodium chewable tablets, 5 mg strength, labeled by AvPAK. The image shows two identical panels indicating the product is Rx only, contains 50 tablets in unit dose packaging (5 x 10), with storage instructions and pediatric patient information for ages 6-14 years. The label includes barcode and manufacturer details for AvKARE, Inc., Pulaski, TN.*
FDA Label Image

Label 5026857515 Montelukast Sodium 2019 10mg

Label 5026857515 Montelukast Sodium 2019 10mg
Montelukast Sodium Tablets 10 mg unit dose packaging label showing two identical panels. Each panel states Rx only with 50 tablets (5 x 10) and includes a barcode. Additional text details adult use, storage instructions at 25°C (77°F), and manufacturer AvPAK, Inc., Pulaski, TN. The label features the AvPAK logo and manufacturing dates.*
FDA Label Image

Figure 1 (Montelukast Sodium Tablets And Chewable Tablets 1)

Figure 1 (Montelukast Sodium Tablets And Chewable Tablets 1)
A line graph showing change in height (cm) over weeks on treatment for three groups: Montelukast Sodium 5 mg, Beclomethasone 336 mcg, and placebo. The x-axis represents weeks on treatment from -19 to 56, and the y-axis represents change in height ranging from -3 to 7 cm.*
FDA Label Image

Chemical Structure (Montelukast Sodium Tablets And Chewable Tablets 2)

Chemical Structure (Montelukast Sodium Tablets And Chewable Tablets 2)
Chemical structure of Montelukast Sodium, showing its molecular framework including a chlorophenyl group, pyridine ring, cyclopropyl group, and a sodium carboxylate moiety.*
FDA Label Image

Figure 2 (Montelukast Sodium Tablets And Chewable Tablets 3)

Figure 2 (Montelukast Sodium Tablets And Chewable Tablets 3)
A line graph showing mean percent change from baseline over 15 weeks of treatment with Montelukast Sodium compared to placebo. Data points for Montelukast Sodium and placebo are plotted, with an additional washout period indicated after week 12. The y-axis measures mean percent change, and the x-axis indicates weeks in treatment.*

* 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.