Montelukast Sodium
Product Images NDC 68151-4186

4 FDA label images from Carilion Materials Management · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 68151-4186). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Carilion Materials Management, 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

Figure 1: Change In Height (cm) From Randomization Visit By Scheduled Week (treatment Group Mean ± Standard Error Of The Mean) (Image 01)

Figure 1: Change In Height (cm) From Randomization Visit By Scheduled Week (treatment Group Mean ± Standard Error Of The Mean) (Image 01)
A line graph showing the change in height (cm) over weeks on treatment for three groups: Montelukast 5 mg, Beclomethasone 336 mcg, and Placebo. The x-axis represents weeks from -19 to 56 and the y-axis shows height change from -3 to 7 cm. Lines indicate group trends in height change during and after treatment.*
FDA Label Image

Montelukast Sodium Structural Formula (Image 02)

Montelukast Sodium Structural Formula (Image 02)
Chemical structure of Montelukast Sodium, showing its molecular configuration including a chlorophenyl group, a cyclopropyl group attached to a sulfoether, and a sodium carboxylate functional group.*
FDA Label Image

Figure 2: Fev1 Mean Percent Change From Baseline (u.s. Trial: Montelukast Sodium N = 406; Placebo N = 270) (anova Model) (Image 03)

Figure 2: Fev1 Mean Percent Change From Baseline (u.s. Trial: Montelukast Sodium N = 406; Placebo N = 270) (anova Model) (Image 03)
A line graph showing mean percent change from baseline over weeks in treatment. Two groups are compared: Placebo (squares, solid line) and Montelukast Sodium (circles, solid and dashed line). Montelukast Sodium group shows a higher increase in percent change over time, with a decline during the washout period. Weeks in treatment are on the x-axis, and mean percent change from baseline on the y-axis.*
FDA Label Image

Label Image (Lbl681514186)

Label Image (Lbl681514186)
Montelukast Sodium 5 MG chewable tablet label shows the product strength and dosage form. It includes manufacturer information (MFG: TEVA), lot number (65M035), expiration date (EXP: 06/16), and additional product codes. A barcode is visible at the bottom.*

* 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.