Montelukast Sodium Tablet, Chewable
Product Images NDC 65162-772

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Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 65162-772). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals 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

6faadd90-figure-01 (Montelukast Sodium Chewable Tablets 1)

6faadd90-figure-01 (Montelukast Sodium Chewable Tablets 1)
The text indicates a graph showing the change in height in centimeters over a period of time (in weeks) as a result of treatment with either Montelukast Sodium 5mg, Beclomethasone 336mcg, or Placebo. However, due to the garbled text in the middle, it is difficult to provide a more detailed description.*
FDA Label Image

6faadd90-figure-02 (Montelukast Sodium Chewable Tablets 2)

FDA Label Image

6faadd90-figure-03 (Montelukast Sodium Chewable Tablets 3)

6faadd90-figure-03 (Montelukast Sodium Chewable Tablets 3)
The text represents a graph showing the mean percent change from baseline for two treatments - placebo and Montelukast Sodium - over 15 weeks. The x-axis represents weeks in treatment and the y-axis represents the percent change from baseline. There is no further information available in the text.*
FDA Label Image

4 mg 30 Ct Label (Montelukast Sodium Chewable Tablets 4)

4 mg 30 Ct Label (Montelukast Sodium Chewable Tablets 4)
NDC 65162-771-03 is Montelukast Sodium Chewable Tablets, USP for pediatric patients aged 2 to 5 years. Each tablet contains 4.2 mg of Montelukast Sodium, USP equivalent to 4 mg of Montelukast. It contains phenylalanine (a component of aspartame) of 0.674 mg per 4 mg chewable tablet. The usual dosage is indicated in the package insert. It is important to keep this drug out of the reach of children and store it in the original package in a dry and dark place, between 20° to 25°C (68° to 77°F), with excursions permitted between 15° to 30°C (59° to 86°F). A medication guide should be dispensed with each tablet. Distributed by Amneal Pharmaceuticals LLC in Bridgewater, NJ 08807. The lot number and expiration date are not available.*
FDA Label Image

5 mg 30 Ct Label (Montelukast Sodium Chewable Tablets 5)

5 mg 30 Ct Label (Montelukast Sodium Chewable Tablets 5)
Montelukast Sodium Chewable Tablets are designed for pediatric patients between 6 to 14 years of age. Each chewable tablet contains 5.2 mg of Montelukast sodium, which is equivalent to 5 mg of Montelukast. A single tablet contains phenylalanine (a component of aspartame) of 0.842 mg per 5 mg of chewable tablet. The usual dosage and full prescribing information is mentioned on the package insert. The pharmacist is advised to dispense an accompanying medication guide to each patient. The tablets should be kept away from children and stored in original packaging at a temperature range of 20° to 25°C. Commercial distribution of the product is undertaken by Amneal Pharmaceuticals LLC. The lot number and expiry date are not available.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.