Montelukast Sodium Tablet, Chewable
Product Images NDC 57237-212

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 57237-212). 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.

FDA Label Image

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

A line graph titled 'Change in Height (cm) from Randomization Visit by Scheduled Week' depicting mean height changes over 56 weeks of treatment. It compares three groups: Montelukast 5 mg, Beclomethasone 336 mcg, and Placebo, with labeled lines and markers. The y-axis shows change in height in centimeters, and the x-axis represents weeks on treatment, including negative weeks before treatment start. Standard errors are noted as too small to show.*

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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)

A line graph depicting the mean percent change from baseline in FEV1 over 15 weeks of treatment, comparing Montelukast Sodium to placebo. The x-axis shows weeks in treatment, and the y-axis shows mean percent change from baseline. Montelukast Sodium demonstrates a higher increase in FEV1 compared to placebo throughout the treatment period, including a washout phase after week 12.*

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

Montelukast Sodium Chewable Tablets USP 4 mg bottle label by Rising Pharma Holdings, Inc. The label indicates 30 chewable tablets for oral use, targeted for pediatric patients aged 2 to 5 years. It includes drug content details, storage instructions, distributor information (Rising Health, LLC, NJ), and a barcode. The label is marked Rx only.*

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

Montelukast Sodium Chewable Tablets USP 5 mg by Rising Pharma Holdings, Inc. The label indicates a 30-count package of chewable tablets for oral use, intended for pediatric patients 6 to 14 years of age. It highlights the presence of 5 mg of montelukast sodium per tablet and notes distribution by Rising Health, LLC, made in India. Additional storage instructions and allergen warnings are included.*

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

Montelukast Sodium 10 mg film-coated tablets label from Rising Pharma Holdings, Inc. The label specifies the dosage form as tablets, quantity of 30 tablets, and includes storage instructions (20° to 25°C). It states the product is for adults 15 years and older and is prescription-only, distributed by Rising Health, LLC, made in India, with a revised date of 05/2020. The NDC code 57237-255-30 is visible.*

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Chemical Structure (Montelukast Str)

Chemical structure diagram of Montelukast Sodium, showing its molecular framework including aromatic rings, a cyclopropyl group, and sodium carboxylate.*

* 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.