Cialis
Product Images NDC 43353-044

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Cialis (NDC 43353-044). 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 5mg (43353 0044 04)

Label for Cialis containing Tadalafil 5 mg tablets. The label indicates a package size of 4 tablets and notes the product is repackaged by Aphena Pharma Solutions - Tennessee, LLC from Indianapolis, IN. The label includes storage instructions and a barcode.*

FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Chemical Structure (Cialis Uspi F001 Structure V1)

Chemical structure diagram of the active ingredient in Cialis, showing its molecular bonds and structure in a black line representation on a white background.*

FDA Label Image

Figure (Cialis Uspi F001 V2)

A line graph showing plasma tadalafil concentration (μg/L) over time (hours) for three dosing regimens: single 20-mg dose, single 5-mg dose, and once-daily 5-mg dose after 5 consecutive days. The graph includes error bars representing variability at each time point.*

FDA Label Image

Figure (Cialis Uspi F002 V1)

A set of four line graphs showing the difference in blood pressure measurements (systolic and diastolic) between tadalafil and placebo over time in hours. The graphs include standing systolic BP, standing diastolic BP, supine systolic BP, and supine diastolic BP, with difference values (mmHg) plotted against time points from 0 to 96 hours.*

FDA Label Image

Figure (Cialis Uspi F003 V1)

Two line graphs depicting changes in standing and supine systolic blood pressure (mmHg) over 24 hours post-dose. The top graph shows standing systolic BP changes for Tadalafil 20 mg & doxazosin 8 mg versus placebo & doxazosin 8 mg. The bottom graph shows supine systolic BP changes with the same treatments. Both graphs track blood pressure changes at hourly intervals from 0 to 24 hours.*

FDA Label Image

Figure (Cialis Uspi F004 V1)

A line graph depicting systolic blood pressure (mmHg) over 12 hours after administration of tadalafil 20 mg or placebo, both combined with doxazosin 8 mg at 08:00. Four lines represent different conditions: tadalafil at 08:00 and 20:00, and placebo at 08:00 and 20:00, showing systolic BP fluctuations over time.*

FDA Label Image

Figure 5 (Cialis Uspi F005 V1)

A line graph comparing change from baseline in IPSS total score over a 12-week treatment duration between Cialis 5 mg and placebo groups. The graph shows mean score changes at 0, 4, 8, and 12 weeks, with the Cialis group exhibiting a greater reduction in scores. An asterisk marks a statistically significant difference (p<0.01) at 12 weeks.*

FDA Label Image

Figure 6 (Cialis Uspi F006 V1)

A line graph comparing change from baseline in IPSS total score over 12 weeks between Cialis 5 mg and placebo. The x-axis represents treatment duration in weeks, and the y-axis shows change from baseline scores. Two lines indicate score trends for Cialis 5 mg (solid line with circles) and placebo (dashed line with triangles), with statistically significant differences marked by asterisks.*

FDA Label Image

Figure 7 (Cialis Uspi F007 V2)

A line graph illustrating the weeks of therapy on the x-axis and least squares mean change from baseline on the y-axis. Two treatment groups are compared: Tadalafil/Finasteride and Placebo/Finasteride, showing a decline from baseline over 26 weeks. Statistically significant differences are noted at weeks 4, 12, and 26 with p-values indicated as a (p<0.001) and b (p<0.05).*

FDA Label Image

Figure 8 (Cialis Uspi F008 V1)

A line graph comparing the change from baseline in IPSS total score over 12 weeks of treatment between Cialis 5 mg and placebo groups. The x-axis represents duration of treatment in weeks (0, 2, 4, 8, 12) and the y-axis shows the change from baseline. The Cialis 5 mg group shows a greater decrease in score than placebo, with statistically significant difference at 12 weeks (p < 0.01).*

* 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.