Montelukast Sodium Tablet, Chewable
Product Images NDC 65862-567

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 65862-567). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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 (Montelukast Fig1)

A line graph titled 'Change in Height (cm) from Randomization Visit by Scheduled Week' comparing the treatment groups Montelukast 5 mg, Beclomethasone 336 mcg, and Placebo. The x-axis shows weeks on treatment from -19 to 56, and the y-axis shows change in height in cm from -3 to 7. Each treatment group is represented by a different marker, illustrating changes in height over time with standard errors noted as too small to be visible.*

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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)

Line graph depicting mean percent change from baseline in FEV1 over 15 weeks in a U.S. trial comparing Montelukast Sodium (N=406) with placebo (N=270). The graph shows higher mean percent improvements for Montelukast Sodium than placebo during treatment weeks with a decline after washout at week 12.*

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

Label for Montelukast Sodium Chewable Tablets USP 4 mg by Aurobindo Pharma Limited. This carton contains 30 chewable tablets with each tablet providing 4 mg of montelukast. The label includes dosage form, strength, pediatric use for ages 2 to 5 years, storage instructions, distribution details, and phenylketonurics warning.*

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

Montelukast Sodium Chewable Tablets USP 5 mg label by Aurobindo Pharma Limited. The label states each chewable tablet contains 5 mg equivalent montelukast. It indicates prescription use with dosage information referencing the prescribing guide. The label notes storage instructions and includes distributor information, barcode, and packaging details. The package size is 30 tablets, intended for pediatric patients aged 6 to 14 years.*

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

Montelukast Sodium Tablets USP 10 mg label for chewable tablets by Aurobindo Pharma Limited. The label indicates the product is for prescription use only and contains 30 tablets. It includes storage instructions, distributor information (Aurobindo Pharma USA, Inc.), and an NDC number 65862-574-30. Made in India.*

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Package Label-principal Display Panel (10 mg Blister Carton (10 x 10 Unit-dose))

Packaging label for Montelukast Sodium Tablets USP 10 mg in unit-dose tablet form. The label indicates 100 tablets (10 x 10), intended for adults 15 years of age and older. The labeler is Aurobindo Pharma Limited, with distribution by Aurobindo Pharma USA, Inc. The packaging includes storage instructions and states the product is for Rx only.*

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Chemical Structure (Montelukast Str)

Chemical structure of Montelukast Sodium, showing a complex arrangement of carbon rings, sulfur, chlorine, and a sodium carboxylate group as part of the molecular structure.*

* 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.