Montelukast Sodium Tablet, Chewable
Product Images NDC 13668-080

15 FDA label images from Torrent Pharmaceuticals Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Montelukast Sodium (NDC 13668-080). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Torrent Pharmaceuticals 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

Chart (Figure 1)

Chart (Figure 1)
A line graph depicting change in height (cm) over weeks on treatment, comparing three groups: Montelukast Sodium 5 mg (n=120), Beclomethasone 336 mcg (n=119), and Placebo (n=121). Height changes are tracked from before treatment (negative weeks) through 56 weeks of treatment.*
FDA Label Image

Str (Structure)

Str (Structure)
Chemical structure of Montelukast sodium, showing the arrangement of rings and functional groups including a chlorine atom, sodium carboxylate, and sulfur-containing groups.*
FDA Label Image

Chart2 (Figure 2)

Chart2 (Figure 2)
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 12 weeks, followed by a washout period to week 15. The y-axis shows mean percent change from baseline, with Montelukast Sodium group achieving higher percent changes than placebo during treatment, and a decline during washout.*
FDA Label Image
FDA Label Image
FDA Label Image

4mg (4mg Indrad)

4mg (4mg Indrad)
Label for Montelukast Sodium Chewable Tablets USP, 4 mg strength, containing 30 tablets. The label specifies pediatric use for ages 2-5 years and includes storage instructions and a pharmacy dispensing note. Manufactured by Torrent Pharmaceuticals Limited and labeled for Torrent Pharma Inc., it highlights the presence of phenylalanine in the tablets and includes the NDC 13668-079-30.*
FDA Label Image

4mg-dahej (4mg Dahej)

4mg-dahej (4mg Dahej)
Montelukast Sodium Chewable Tablets, USP 4 mg label from Torrent Pharmaceuticals Limited. The label indicates a package of 30 tablets with NDC 13668-079-30. It highlights pediatric use for patients 2-5 years old and notes the presence of phenylalanine. Storage and handling instructions are included, along with manufacturer and distributor information.*
FDA Label Image

5mg (5mg)

5mg (5mg)
Montelukast Sodium Chewable Tablets, USP 5 mg in a 30-tablet package by Torrent Pharmaceuticals Limited. The label includes storage instructions, a note that each tablet contains 5.2 mg montelukast sodium (equivalent to 5 mg montelukast), and a warning for phenylketonurics about phenylalanine content. The product is for pediatric patients 6-14 years and is prescription only (Rx only). The NDC is 13668-080-30.*
FDA Label Image

5mg-dahej (5mg Dahej)

5mg-dahej (5mg Dahej)
Label for Montelukast Sodium Chewable Tablets, USP 5 mg, manufactured by Torrent Pharmaceuticals Limited. The label includes dosage form (chewable tablets), strength (5 mg), quantity (30 tablets), and NDC 13668-080-30. It mentions pediatric use for ages 6-14 years and contains warning about phenylketonurics due to phenylalanine. Storage instructions and manufacturer details are provided.*
FDA Label Image

10mg (10mg)

10mg (10mg)
Montelukast Sodium Tablets, USP 10 mg, blister pack containing 30 tablets. Label indicates the product is for adult use 15 years and older, with storage instructions and a note for pharmacists to dispense the Medication Guide. Manufactured by Torrent Pharmaceuticals Limited, the label includes the NDC 13668-081-30 and specifies prescription use only (Rx only).*
FDA Label Image

10mg-dahej (10mg Dahej)

10mg-dahej (10mg Dahej)
Montelukast Sodium Tablets USP 10 mg label from Torrent Pharmaceuticals Limited. The label specifies 30 tablets, with storage instructions, dosage guidance for adults 15 years and older, and a directive for pharmacists to dispense the accompanying medication guide. Includes an NDC code 13668-081-30 and barcode.*
FDA Label Image

Sachet (Sachet)

Sachet (Sachet)
Montelukast Sodium Oral Granules USP 4 mg packet label from Torrent Pharmaceuticals Limited. The label indicates use for pediatric patients 6 months to 5 years of age, with instructions to fold and tear or cut at the dotted line to open. Each packet contains 4.16 mg Montelukast sodium USP, equivalent to 4 mg Montelukast. The label also lists inactive ingredients and includes an NDC number 13668-531-11.*
FDA Label Image

Sachet-dahej (Sachet Dahej)

Sachet-dahej (Sachet Dahej)
Montelukast Sodium Oral Granules USP 4 mg packet label from Torrent Pharmaceuticals Limited. The label indicates the product strength as 4 mg, intended for pediatric patients 6 months to 5 years old. It includes opening instructions, NDC 13668-531-11, and lists excipients such as mannitol and magnesium stearate. The product is labeled Rx only.*
FDA Label Image

Carton (Carton)

Carton (Carton)
Montelukast Sodium Oral Granules USP 4 mg carton label by Torrent Pharmaceuticals Limited. The label indicates pediatric use for patients 6 months to 5 years of age, contains 30 packets, and is Rx only. It provides storage and usage instructions and includes the manufacturer details and NDC 13668-531-94.*
FDA Label Image

Carton-dahej (Carton Dahej)

Carton-dahej (Carton Dahej)
Montelukast Sodium Oral Granules USP 4 mg packet packaging label. This box contains 30 packets for pediatric use in patients 6 months to 5 years old. The label includes dosage information, storage instructions, and manufacturer details for Torrent Pharmaceuticals Limited. The label states Rx only and includes the NDC 13668-531-94.*

* 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.