Montelukast Tablet, Film Coated
Product Images NDC 0781-5560

6 FDA label images from Sandoz Inc · 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 (NDC 0781-5560). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sandoz 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

Montelukast 01

Montelukast 01
Line graph comparing change in height over weeks of treatment among three groups: Montelukast 5 mg, Beclomethasone 336 mcg, and Placebo. The y-axis shows change in height in centimeters, and the x-axis shows weeks on treatment from -19 to 56. Data points for each group are connected with different markers and the graph depicts growth trends during the treatment period.*
FDA Label Image

Montelukast 02

Montelukast 02
Chemical structure of Montelukast shown as a molecular diagram with labeled atoms and bonds. The image depicts the chemical arrangement relevant to the active ingredient Montelukast in the product.*
FDA Label Image

Montelukast 03

Montelukast 03
A line graph depicting mean percent change from baseline over weeks in treatment for Montelukast 10 mg tablets compared to placebo. The x-axis represents time in weeks up to week 15 including a washout period, and the y-axis shows the mean percent change. Montelukast shows a higher increase than placebo through week 12, with error bars indicating variability.*
FDA Label Image

Montelukast 04

Montelukast 04
Montelukast Sodium Chewable Tablets 5 mg, for pediatric patients aged 6 to 14 years. The label indicates 30 tablets per package, with warnings for phenylketonurics regarding phenylalanine content. Manufacturer is Sandoz Inc., with production in India. The label includes storage instructions and a barcode.*
FDA Label Image

Montelukast 05

Montelukast 05
Montelukast Sodium Tablets 10 mg film-coated tablets label for adult use aged 15 years and older. The label states Rx Only and package contains 30 tablets. Manufactured by Sandoz Inc, with storage instructions and caution to keep drugs out of reach of children. Features the NDC 0781-5560-31 and a barcode on the right side.*
FDA Label Image

Montelukast 06

Montelukast 06
Montelukast Sodium Chewable Tablets 4 mg for pediatric patients 2 to 5 years of age. Bottle contains 30 chewable tablets. Label states it is Rx only and manufactured by Sandoz Inc. Includes storage instructions, a phenylketonurics warning about phenylalanine content, and a barcode on the right side.*

* 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.