Tadalafil
Product Images NDC 71610-298

12 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 71610-298). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, 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 Label 5 mg (71610 0298 08)

Bottle Label 5 mg (71610 0298 08)
Tadalafil 5 mg tablet bottle label from Aphena Pharma Solutions - Tennessee, LLC, containing 8 tablets. The label includes storage instructions, manufacturer Hetero Labs Limited in Hyderabad, India, and the distributor Aphena Pharma in Cookeville, TN. It is marked Rx only and includes lot number and expiration date details.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Camber1jpj (Camber1jpg)

FDA Label Image

Tadalafilfigure1.jpg (Tadalafilfigure1)

Tadalafilfigure1.jpg (Tadalafilfigure1)
Four line graphs showing blood pressure changes over time for Tadalafil compared to placebo. Graphs depict differences in standing systolic BP, standing diastolic BP, supine systolic BP, and supine diastolic BP measured in mmHg across various time intervals up to 96 hours.*
FDA Label Image

Tadalafilfigure2.jpg (Tadalafilfigure2)

Tadalafilfigure2.jpg (Tadalafilfigure2)
A two-part line graph showing standing and supine systolic blood pressure (mmHg) over 24 hours post-dose. The upper graph compares Tadalafil 20 mg combined with doxazosin 8 mg to placebo with doxazosin 8 mg on standing systolic blood pressure. The lower graph shows the same comparison for supine systolic blood pressure over time.*
FDA Label Image

Tadalafilfigure4.jpg (Tadalafilfigure4)

Tadalafilfigure4.jpg (Tadalafilfigure4)
A line graph showing systolic blood pressure (mmHg) changes over 12 hours after administration of tadalafil or placebo combined with doxazosin, comparing different combinations of tadalafil doses and timing. The x-axis represents time post-dose, and the y-axis shows systolic blood pressure variation from baseline.*
FDA Label Image

Tadalafilfigure5.jpg (Tadalafilfigure5)

Tadalafilfigure5.jpg (Tadalafilfigure5)
A pharmacokinetic line graph showing plasma tadalafil concentration (µg/L) on the vertical axis versus time (hours) on the horizontal axis. The graph compares three dosing regimens: a single 20-mg tadalafil dose, a single 5-mg tadalafil dose, and once-daily 5-mg tadalafil following 5 consecutive days of administration. Concentration levels peak early and decline over time with error bars shown.*
FDA Label Image

Tadalfilfigure6.jpg (Tadalafilfigure6)

Tadalfilfigure6.jpg (Tadalafilfigure6)
A line graph showing the change from baseline in IPSS Total Score over a 12-week treatment period. The x-axis represents Duration of Treatment (weeks) and the y-axis shows the Change from Baseline in IPSS Total Score. Two lines compare Tadalafil 5 mg and placebo, with Tadalafil showing a greater decrease in score over time. A statistical significance marker (*p<0.01) is indicated on the graph.*
FDA Label Image

Tadalafilfigure7.jpg (Tadalafilfigure7)

Tadalafilfigure7.jpg (Tadalafilfigure7)
A line graph showing change from baseline in IPSS total score over 12 weeks comparing Tadalafil 5 mg treatment to placebo. The x-axis represents duration of treatment in weeks, and the y-axis shows the change in score. Tadalafil shows a greater decrease in score compared to placebo over time, with statistical significance indicated at certain points.*
FDA Label Image

Tadalafilfigure8 (Tadalafilfigure8)

Tadalafilfigure8 (Tadalafilfigure8)
A line graph depicting the least squares mean change from baseline in a measure over 26 weeks of therapy comparing Tadalafil/Finasteride and Placebo/Finasteride. Data points are shown at weeks 0, 4, 12, and 26, with Tadalafil/Finasteride displaying greater improvement throughout the duration. Statistical significance markers for p<0.001 and p<0.05 are noted.*
FDA Label Image

Tadalfilfigure9.jpg (Tadalafilfigure9)

Tadalfilfigure9.jpg (Tadalafilfigure9)
A line graph depicting the change from baseline in IPSS total score over a 12-week treatment duration comparing Tadalafil and placebo groups. The graph shows a greater decrease in IPSS score for Tadalafil compared to placebo, with data points at multiple weeks, and a note indicating statistical significance (p<0.01).*
FDA Label Image

Tadalafilstructure.jpg (Tadalafilstructure)

Tadalafilstructure.jpg (Tadalafilstructure)
Chemical structure diagram of the active ingredient Tadalafil, showing the molecular arrangement including fused ring systems and functional groups as depicted.*

* 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.