Mesalamine Capsule, Extended Release
Product Images NDC 50742-371

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Mesalamine (NDC 50742-371). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ingenus Pharmaceuticals, Llc, 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

Bottle (Bottle)

This is a product label for Mesalamine Extended-Release Capsules. Each capsule contains 0.375 g of mesalamine. The recommended storage temperature is between 20° and 25°C (68° to 77°F), with excursions allowed between 15° and 30°C (59° and 86°F). The label also includes information on prescribing, dosage, and precautions like keeping out of reach of children. The expiration date and lot number are provided for reference.*

FDA Label Image

Mesalamine Structural Formula (Image 02)

FDA Label Image

Logo (Logo)

FDA Label Image

Table1 (Table1)

This is a table showing common adverse reactions observed in clinical trials for adults with Ulcerative Colitis comparing Mesalamine Extended-Release Capsules and Placebo. Adverse reactions listed include Headache, Diarrhea, Upper Abdominal Pain, Nausea, and Nasopharyngitis with corresponding percentages for each treatment group.*

FDA Label Image

Table2 (Table2)

This is a table displaying the mean plasma pharmacokinetic parameters of Mesalamine (5-ASA) and N-Ac-5-ASA after the administration of 1.5 g Mesalamine Extended-Release Capsules in healthy subjects. It provides details such as AUC, Cmax, T(max), and t1/2 for both single-dose and multiple-dose regimens of Mesalamine and N-Ac-5-ASA. The data is presented with standard deviations for each parameter.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.