Darifenacin
Product Images NDC 70754-162

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Darifenacin (NDC 70754-162). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alan Laboratories, Inc., 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

Chemical Structure (Darifenacin 01)

Chemical structure diagram of darifenacin, showing its molecular framework including a fused ring system, piperidine ring, and functional groups. The image depicts the arrangement of atoms and bonds characteristic of darifenacin's chemical composition.*

FDA Label Image

Figure 1 (Darifenacin 02)

A line graph showing darifenacin plasma concentration (ng/mL) over time post-dose in hours, comparing 7.5 mg once daily (od) and 15 mg once daily doses. The graph includes mean values and standard deviations, illustrating higher concentrations for the 15 mg dose throughout 24 hours.*

FDA Label Image

Figure 2a (Darifenacin 03)

A line graph showing median reduction (and 95% confidence interval) in incontinence episodes per week from baseline over time (weeks). The graph compares placebo and two darifenacin dosages, 7.5 mg and 15 mg, indicating greater reduction with higher darifenacin dose across 2, 6, and 12 weeks.*

FDA Label Image

Figure 2b (Darifenacin 04)

A line graph showing median reduction in incontinence episodes per week over 12 weeks, comparing placebo, darifenacin 7.5 mg, and darifenacin 15 mg groups. The y-axis shows median reduction from baseline, and the x-axis shows time in weeks. Darifenacin 15 mg shows the greatest reduction, followed by 7.5 mg, and placebo the least.*

FDA Label Image

Figure 2c (Darifenacin 05)

A line graph depicting median reduction (and 95% confidence intervals) in incontinence episodes per week from baseline over 12 weeks. Two lines represent placebo (dashed line with circles) and darifenacin 15 mg (solid line with squares). The darifenacin 15 mg group shows a greater decrease in incontinence episodes compared to placebo over time. The x-axis is labeled "Time (Weeks)" and the y-axis shows the median reduction from baseline.*

FDA Label Image

Principal Display Panel (7.5 mg 30 Tablet Bottle Label)

Darifenacin Extended-Release Tablets 7.5 mg per tablet, supplied as a package of 30 tablets. The label shows the active ingredient darifenacin hydrobromide equivalent to 7.5 mg darifenacin, with usual dosage instructions to take one tablet daily. It includes storage directions to keep at 25°C (77°F) with permitted excursions between 15 to 30°C, protecting the product from light. Manufactured by Alan Laboratories, Inc.*

FDA Label Image

Principal Display Panel (7.5 mg 500 Tablet Bottle Label)

Darifenacin Extended-Release Tablets 7.5 mg per tablet label showing 500 tablets by Alan Laboratories, Inc. The label includes dosage strength, tablet count, storage and handling instructions, manufacturer and labeler information, and contact details for reporting adverse reactions. The label has a barcode on the right side and states Rx only.*

FDA Label Image

Principal Display Panel (15 mg 30 Tablet Bottle Label)

Darifenacin Extended-Release Tablets 15 mg label from Alan Laboratories, Inc. The label shows the product name, strength (15 mg), and dosage form as tablets. It indicates a count of 30 tablets per package. Additional information includes storage instructions, usage dosage, lot, and expiration fields, along with manufacturer contact details and a barcode.*

FDA Label Image

Principal Display Panel (15 mg 500 Tablet Bottle Label)

Darifenacin Extended-Release Tablets 15 mg label showing a package containing 500 tablets. The label includes usage instructions, storage information, and contact details for adverse reaction reporting. It is manufactured by Alan Laboratories, Inc., and specifies the active ingredient amount per tablet.*

* 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.