Montelukast Sodium Tablet, Chewable
Product Images NDC 55111-593

9 FDA label images from Dr.reddy's Laboratories Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 55111-593). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Dr.reddy's Laboratories 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.

FDA Label Image

10mgcarton (10mgcarton)

10mgcarton (10mgcarton)
Montelukast Sodium Tablets USP 10 mg carton label by Dr. Reddy's Laboratories Limited. The label indicates a package of 100 coated tablets (10 x 10 unit-dose), for adults 15 years of age and older. Instructions note the tablet contains 10.4 mg Montelukast Sodium USP equivalent to 10 mg Montelukast, with storage at 20°C to 25°C and protection from moisture and light. The distributor address and a QR code for medication guides are also included.*
FDA Label Image

10mgcontainer90 (10mgcontainer90)

10mgcontainer90 (10mgcontainer90)
Montelukast Sodium Tablets USP 10 mg, coated tablets for oral use, indicated for adults 15 years and older. The label shows a prescription-only medication with 90 tablets per container. Labeled and distributed by Dr. Reddy's Laboratories Limited. The packaging includes a medication guide reference and barcode.*
FDA Label Image

4mgcarton (4mgcarton)

4mgcarton (4mgcarton)
Label for Montelukast Sodium Chewable Tablets 4 mg by Dr. Reddy's Laboratories Limited. The label specifies the product is for pediatric patients aged 2-5 years, with 100 tablets per pack (10 x 10 unit-dose blisters). It includes storage instructions, phenylketonurics warning, and states the tablets contain 4 mg Montelukast equivalent. The label design features the manufacturer information and NDC 55111-593-78.*
FDA Label Image

4mgcontainer (4mgcontainer)

4mgcontainer (4mgcontainer)
Label for Montelukast Sodium Chewable Tablets 4 mg from Dr. Reddy's Laboratories Limited. The label indicates the product is for pediatric patients ages 2-5 years, contains 90 tablets, and requires dispensing the patient information leaflet. It includes dosage and storage instructions, manufacturer details, a barcode, and a QR code linking to patient information.*
FDA Label Image

5mgcarton (5mgcarton)

5mgcarton (5mgcarton)
Montelukast Sodium Chewable Tablets, 5 mg, packaging label for pediatric patients aged 6-14 years. The label indicates 100 tablets (10 x 10 unit-dose) in the package and states it is for prescription use only. Manufactured by Dr. Reddy's Laboratories Limited, India. The label includes storage instructions and a phenylalanine warning due to aspartame content.*
FDA Label Image

5mgcontainer (5mgcontainer)

5mgcontainer (5mgcontainer)
Montelukast Sodium Chewable Tablets 5 mg packaging label from Dr. Reddy's Laboratories Limited. The label indicates the product is for pediatric patients 6-14 years of age, with a count of 90 tablets. It includes instructions for pharmacists to dispense a patient information leaflet and provides storage conditions and dosage guidance.*
FDA Label Image

Figure1 (Figure1)

Figure1 (Figure1)
A line graph showing the change in height (cm) over weeks on treatment for Montelukast Sodium 5 mg, Beclomethasone 336 mcg, and placebo groups. The x-axis represents weeks on treatment, and the y-axis shows the change in height, with distinct lines for each treatment group.*
FDA Label Image

Figure2 (Figure2)

Figure2 (Figure2)
Line graph showing mean percent change from baseline over weeks in treatment, comparing Montelukast Sodium and placebo groups. The x-axis represents weeks in treatment up to 15 weeks, including a 3-week washout period. Error bars indicate variability in data. Montelukast Sodium shows a greater increase over time compared to placebo.*
FDA Label Image

Structure (Structure)

Structure (Structure)
Chemical structure diagram of Montelukast Sodium, showing its molecular arrangement including chlorine, sulfur, sodium carboxylate groups, and aromatic rings consistent with the known chemical formula.*

* 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.