Tadalafil Tablet
Product Images NDC 43547-033

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 43547-033). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Solco Healthcare Us, 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

F35596a7-figure-01 (F35596a7 Figure 01)

Chemical structure of tadalafil, the active ingredient in TADALAFIL tablets. The diagram shows the molecular arrangement of atoms in the compound.*

FDA Label Image

F35596a7-figure-02 (F35596a7 Figure 02)

A set of four line graphs showing the difference in blood pressure measurements (tadalafil minus placebo) over time in hours. The graphs present standing systolic BP, standing diastolic BP, supine systolic BP, and supine diastolic BP in mmHg, illustrating the effects of tadalafil on these parameters across 0 to 96 hours.*

FDA Label Image

F35596a7-figure-03 (F35596a7 Figure 03)

This figure presents two line graphs comparing the effects of Tadalafil 20 mg with doxazosin 8 mg versus placebo with doxazosin 8 mg on standing and supine systolic blood pressure over 24 hours post-dose. The vertical axes measure systolic blood pressure changes in mmHg, while the horizontal axis shows time in hours post-dose.*

FDA Label Image

F35596a7-figure-04 (F35596a7 Figure 04)

A line graph depicting systolic blood pressure (mmHg) changes over 12 hours after administration of tadalafil or placebo with doxazosin. The x-axis shows time after administration, and the y-axis shows systolic BP change. Four data series compare 20 mg tadalafil at 08:00 and 20:00 with placebo, all combined with 8 mg doxazosin at 08:00.*

FDA Label Image

F35596a7-figure-05 (F35596a7 Figure 05)

A line graph depicting plasma tadalafil concentration (μg/L) over time (hours) for single 20 mg dose, single 5 mg dose, and once-daily 5 mg dose after 5 consecutive days. The y-axis shows plasma concentration from 0 to 500 μg/L, and the x-axis shows time from 0 to 120 hours. Data points include error bars for variability.*

FDA Label Image

F35596a7-figure-06 (F35596a7 Figure 06)

A line graph showing change from baseline in IPSS Total Score over 12 weeks of treatment, comparing Tadalafil 5 mg tablets and placebo. The y-axis represents score change; the x-axis shows treatment duration in weeks. Tadalafil shows a greater decrease in IPSS score over time compared to placebo, with a significant difference indicated at week 12 (p<0.01).*

FDA Label Image

F35596a7-figure-07 (F35596a7 Figure 07)

A line graph showing the change from baseline in IPSS Total Score over 12 weeks for Tadalafil tablets 5 mg compared to placebo. The x-axis represents duration of treatment in weeks, and the y-axis shows the change from baseline score. Tadalafil 5 mg shows a greater reduction in score than placebo, with significant differences marked at week 4 and week 12 (p<0.01).*

FDA Label Image

F35596a7-figure-08 (F35596a7 Figure 08)

A line graph showing least-squares mean change from baseline over 26 weeks of therapy comparing Tadalafil/Finasteride and Placebo/Finasteride. The x-axis represents weeks of therapy (0, 4, 12, 26) and the y-axis shows LS mean change from baseline with values decreasing to approximately -6. Tadalafil/Finasteride shows a greater reduction versus Placebo/Finasteride at each time point, with significance markers for p<0.001 and p<0.05 noted.*

FDA Label Image

F35596a7-figure-09 (F35596a7 Figure 09)

A line graph showing change from baseline in IPSS Total Score over a 12-week treatment duration. It compares tadalafil tablets 5 mg (solid line with circles) and placebo (dashed line with triangles), indicating a greater decrease in IPSS score for tadalafil over time. Statistical significance is noted at week 12 (p<0.01).*

FDA Label Image

2.5 mg Strengrh (F35596a7 Figure 10)

Tadalafil Tablets, USP 2.5 mg oral tablets packaged in a container with a label from Solco Healthcare US, LLC. The label indicates a quantity of 30 tablets, with instructions that tablets should not be split and the entire dose should be taken. Storage and manufacturer information are provided, including the NDC 43547-030-03 and a barcode on the right side.*

FDA Label Image

5 mg Strengrh (F35596a7 Figure 11)

Tadalafil Tablets USP 5 mg oral tablet label by Solco Healthcare US, LLC. The label shows the product name, strength, and provides storage instructions, manufacturer and distributor details. It states the tablets should not be split and contains 30 tablets per bottle. The label includes a barcode and a specification for no coating dimensions.*

FDA Label Image

10 mg Strengrh (F35596a7 Figure 12)

Label for Tadalafil Tablets, USP 10 mg by Solco Healthcare US, LLC. The label includes storage instructions, dosage note to see accompanying literature, and warnings. It specifies the product contains 10 mg tadalafil per tablet, comes in a package of 30 tablets, and includes manufacturing and distribution details. The barcode and NDC number 43547-032-03 appear on the label.*

FDA Label Image

20 mg Strength (F35596a7 Figure 13)

Packaging label for Tadalafil Tablets USP 20 mg oral tablets by Solco Healthcare US, LLC. The label includes dosage warnings, storage instructions, and manufacturer details (Prinston Laboratories, Charlotte, NC). The package contains 30 tablets and advises not to split tablets. It features a barcode and the NDC number 43547-033-03.*

* 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.