Tadalafil Tablet, Film Coated
Product Images NDC 33342-268

18 FDA label images from Macleods Pharmaceuticals Limited · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 33342-268). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Macleods Pharmaceuticals Limited, 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

Stru (Tadalafil Structure)

Stru (Tadalafil Structure)
Chemical structure diagram of the active ingredient tadalafil, showing its molecular framework with multiple rings including an indole and a tetrahydrofuran moiety.*
FDA Label Image

Fig1 (Tadalafil Figure 1)

Fig1 (Tadalafil Figure 1)
This figure contains four line graphs displaying blood pressure changes over time in hours. The top left graph shows standing systolic blood pressure differences between tadalafil and placebo. The top right graph shows standing diastolic blood pressure differences. The bottom left graph shows supine systolic blood pressure differences, and the bottom right graph shows supine diastolic blood pressure differences over the same time period. Error bars indicate variability at each time point.*
FDA Label Image

Fig (Tadalafil Figure 2)

Fig (Tadalafil Figure 2)
A figure consisting of two line graphs showing changes in systolic blood pressure (mmHg) over 24 hours post-dose (h). The top graph displays standing systolic blood pressure, and the bottom graph shows supine systolic blood pressure. Both graphs compare Tadalafil 20 mg plus doxazosin 8 mg versus placebo plus doxazosin 8 mg, with time on the x-axis and blood pressure on the y-axis.*
FDA Label Image

Fig (Tadalafil Figure 3)

Fig (Tadalafil Figure 3)
A line graph showing the effects on systolic blood pressure (mmHg) over 12 hours after administration of tadalafil or placebo combined with 8 mg daily doxazosin at two different times (08:00 and 20:00). The chart compares 20 mg tadalafil versus placebo for each dosing time, illustrating blood pressure changes over time.*
FDA Label Image

Fig (Tadalafil Figure 4)

Fig (Tadalafil Figure 4)
A pharmacokinetic graph showing plasma concentration of Tadalafil (µg/L) over time (hours). It compares single 20 mg and 5 mg doses, and once-daily 5 mg dosing after 5 days, with error bars indicating variability in plasma levels over approximately 120 hours.*
FDA Label Image

Fig (Tadalafil Figure 5)

Fig (Tadalafil Figure 5)
A line graph comparing the change from baseline in IPSS total score over 12 weeks between Tadalafil 5 mg tablets and placebo. The x-axis shows treatment duration in weeks (0, 4, 8, 12), and the y-axis shows change in score. Tadalafil shows a greater reduction over time compared to placebo, with statistical significance indicated at p<0.01.*
FDA Label Image

Fig (Tadalafil Figure 6)

Fig (Tadalafil Figure 6)
A line graph comparing change from baseline in IPSS Total Score over a 12-week treatment duration between Tadalafil 5 mg tablets and placebo groups. The X-axis represents treatment duration in weeks, and the Y-axis shows the change in IPSS score, with Tadalafil showing a greater reduction compared to placebo, with statistical significance at week 4 (p<0.01).*
FDA Label Image

Fig (Tadalafil Figure 7)

Fig (Tadalafil Figure 7)
A line graph depicting the least-squares (LS) mean change from baseline over 26 weeks of therapy, comparing Tadalafil/Finasteride and Placebo/Finasteride treatment groups. The x-axis represents weeks of therapy (0, 4, 12, 26), and the y-axis measures LS mean change values from 0 to -7. Data points include statistical significance markers 'a' (p<0.001) and 'b' (p<0.05). The graph illustrates greater LS mean decreases for the Tadalafil/Finasteride group compared to Placebo/Finasteride.*
FDA Label Image

Fig (Tadalafil Figure 8)

Fig (Tadalafil Figure 8)
A line graph comparing change from baseline in IPSS total score over a 12-week treatment duration between Tadalafil Tablets 5 mg and placebo groups. The x-axis represents treatment duration in weeks, and the y-axis shows the change in IPSS score. The Tadalafil group shows a greater reduction in score compared to placebo, with statistical significance indicated.*
FDA Label Image

111 (Tadalafil Tablets 2 5 30s)

111 (Tadalafil Tablets 2 5 30s)
The label for Tadalafil Tablets USP 2.5 mg film-coated tablets by Macleods Pharmaceuticals Ltd. It indicates a package of 30 tablets for once daily use, with dosage strength prominently shown in purple. The label includes storage instructions, manufacturer details, and warnings to keep out of reach of children and not to split tablets.*
FDA Label Image

898 (Tadalafil 2 5 30s Daman)

898 (Tadalafil 2 5 30s Daman)
Label for Tadalafil Tablets USP 2.5 mg film-coated tablets by Macleods Pharmaceuticals Ltd. and Macleods Pharma USA, Inc. The label states the dosage form, strength, and packaging of 30 tablets with directions to take whole tablets. Storage instructions and warnings to keep out of reach of children are included. Manufacturer details and barcodes are visible.*
FDA Label Image

898 (Tadalafil 2 5 1000s Daman)

898 (Tadalafil 2 5 1000s Daman)
Label for Tadalafil Tablets, USP 2.5 mg film-coated tablets by Macleods Pharmaceuticals Limited. The label states the product is for once daily use, with instructions not to split tablets and to take the entire dose. It includes storage conditions, warnings to keep out of reach of children, and details of manufacturing sites in the USA and India. The package contains 1000 tablets.*
FDA Label Image

222 (Tadalafil Tablets 5 30s)

222 (Tadalafil Tablets 5 30s)
Label for Tadalafil Tablets, USP 5 mg, film coated oral tablets by Macleods Pharmaceuticals Limited. The label states a 30-tablet package and includes storage instructions, dosage warning, manufacturer details for Macleods Pharma USA, Inc., and Macleods Pharmaceuticals Ltd. It specifies tablets should not be split and must be kept out of reach of children.*
FDA Label Image

565 (Tadalafil 5 30s Daman)

565 (Tadalafil 5 30s Daman)
Label for Tadalafil Tablets, USP 5 mg film-coated tablets by Macleods Pharmaceuticals Limited. The packaging indicates 30 tablets per container. Includes storage instructions, warnings, and manufacturer details for Macleods Pharma USA, Inc. and Macleods Pharmaceuticals Ltd.*
FDA Label Image

444 (Tadalafil Tablets 10 30s)

444 (Tadalafil Tablets 10 30s)
Tadalafil Tablets USP 10 mg film coated tablets label by Macleods Pharmaceuticals Limited. The label, marked for Macleods Pharma USA distribution, states a 30 tablet count. It includes dosage warnings, storage instructions (20 to 25°C), and advises tablets should not be split. Contains barcodes and manufacturing location in India.*
FDA Label Image

454 (Tadalafil 10 30s Daman)

454 (Tadalafil 10 30s Daman)
Tadalafil Tablets USP 10 mg film-coated tablets label from Macleods Pharmaceuticals Limited. The label includes dosage strength (10 mg), package size (30 tablets), handling instructions to not split tablets and to take entire dose, storage conditions, and manufacturer information for Macleods Pharma USA and Macleods Pharmaceuticals Ltd. The label also features barcodes and a designated printable area.*
FDA Label Image

666 (Tadalafil Tablets 20 30s)

666 (Tadalafil Tablets 20 30s)
Label for Tadalafil Tablets USP 20 mg film-coated oral tablets, containing 30 tablets per container. The label includes storage instructions, manufacturer information for Macleods Pharma USA, Inc. and Macleods Pharmaceuticals Ltd., and warnings not to split tablets and to keep out of reach of children. The label displays barcodes and NDC 33342-268-07.*
FDA Label Image

565 (Tadalafil 20 30s Daman)

565 (Tadalafil 20 30s Daman)
Label for Tadalafil Tablets, USP 20 mg film coated tablets by Macleods Pharmaceuticals Limited. The label indicates a package size of 30 tablets with a storage temperature range of 20° to 25°C. The labeler is Macleods Pharma USA, Inc., Princeton, NJ, with manufacturing noted in Daman, India.*

* 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.