Montelukast Sodium Tablet, Chewable
Product Images NDC 33342-110

This is a description of a medication called Montelukast Sodium Chewable Tablets, USP. The tablets are manufactured by Macleods Pharma USA, and come in a package with 100 (10x10) united dose tablets. The tablets are meant for pediatric patients who are 2.5 years of age or older. The usual dosage instructions are listed on the prescribing information, which is included with the tablets. The tablets should be stored in the original package, protected from moisture and light, and kept out of reach of children. The package label also includes information on the expiration date and the ingredients in the tablets.*

This is a medicine called Magzony which comes in chewable tablets containing 4.2 mg of montelukast sodium USP equivalent to montelukast 4 mg, and is typically prescribed for pediatric patients aged 2-5 years. The tablets come in a container of 30 pieces and should be stored in a cool place, away from light and out of reach of children. The medicine contains phenylalanine (as a component of aspartame) and is manufactured by Macleods Pharma USA, Inc. in Princeton, NJ 08540. It is also manufactured by Macleods Pharmaceuticals Ltd. in Badd, Himachal Pradesh, India. Dosage information is available in the Prescribing Information, and there is an attached Patient Information Leaflet.*

Montelukast Sodium Chewable Tablets, USP is a medication for pediatric patients aged 6 to 14 years old. It is produced by Macleods Pharma USA in Princeton, NJ and contains 52mg of montelukast sodium USP. The medication comes in 100 unit-dose packages and its usual dosage can be found in the prescribing information. It should be stored in original packaging at a temperature between 20°C and 25°C and protected from light. The package includes a patient information leaflet to be dispensed by a pharmacist. Phenylalanine is a component of aspartame present in the product and it should not be provided to phenylketonurics.*

Each chewable tablet contains 52 mg of montelukast sodium USP, which is equivalent to 5 mg of montelukast. The product is intended for patients of at least 6 years of age. The precise dosage should be determined by the doctor prescribing the drug. The medication is made in India by Macleods Pharmaceuticals and sold in the US by Macleods Pharma USA. The tablets should be kept in their original packaging, in tightly-closed containers protected from light, at a controlled room temperature between 15°C and 30°C. The package contains 30 tablets. Phenylketonurics should be aware that the aspartame component of the drug contains 0.842 mg of phenylalanine per tablet.*

This is a graph showing the change in height (in centimeters) over weeks on treatment for three different groups. The three groups are 8-8-8 Montelukast sodium (n=120), 4& micro;g Beclomethasone (n=119), and placebo (n=121). The graph suggests that the standard errors of the treatment group means in change in height are too small to be visible on the plot.*

The text is a table that shows the mean percent change from baseline for a treatment over 15 weeks, with measurements taken at weeks 0, 3, 6, 9, 12, and 15. The treatments evaluated are a Placebo and Montelukast Sodium.*