Montelukast Sodium Tablet, Film Coated
Product Images NDC 57237-255

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 57237-255). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Rising Pharma Holdings, 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.

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Figure 1: Change In Height (cm) From Randomization Visit By Scheduled Week (treatment Group Mean ± Standard Error* Of The Mean) (Montelukast Fig1)

The figure shows the change in height (cm) from the randomization visit by scheduled week for three treatment groups: Nontelukast 5 mg (n=120), Beclomethasone 336 meg (n=119), and Placebo (n=121). The standard errors of the treatment group means in change in height are too small to be visible on the plot.*

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Figure 2: Fev1 Mean Percent Change From Baseline (u.s. Trial: Montelukast Sodium N=406; Placebo N=270) (anova Model) (Montelukast Fig2)

This is a chart showing the mean percent change from baseline in FEV over 15 weeks of treatment with Montelukast Sodium or Placebo in a U.S. Trial. The chart was analyzed using ANOVA model. The x-axis shows the weeks in treatment, including a washout phase, and the y-axis shows the mean percent change from baseline.*

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Package Label-principal Display Panel (4 mg (30 Tablets Bottle))

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Package Label-principal Display Panel (5 mg (30 Tablets Bottle))

Rising® Montelukast is a medication available in the form of chewable tablets containing 5.19 mg of montelukast sodium USP, equivalent to 5 mg of montelukast. It is prescribed for pediatric patients aged 6 to 14 years. The medication guide should be dispensed to each patient by the pharmacist. It contains phenylalanine and should be kept away from children. The tablets should be stored at a temperature of 20° to 25°C (68° to 77°F) and protected from moisture and light. Distributed by Rising Health, LLC, it is made in India. The code for the medication is TS/DRUGS/22/2009, revised in May 2020.*

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Package Label-principal Display Panel (10 mg (30 Tablets Bottle))

Rising® is a medication containing 30 tablets of Montelukast Sodium USP, with a dosage for adults of 15 years and older. Each film-coated tablet contains 10.38 mg of Montelukast Sodium, equivalent to 10 mg of Montelukast. It is necessary to dispense the medication guide separately to each patient. The usual dosage depends on the prescribing information. The tablets should be stored in the original package, protected from moisture and light at 20° to 25°C (68° to 77°F) in a USP Controlled Room Temperature. This drug has been distributed by Rising Health, LLC located in Saddle Brook, NJ 07663 and was made in India. Last revised in May 2020.*

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Chemical Structure (Montelukast Str)

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