Tadalafil Tablet, Film Coated
Product Images NDC 42291-866

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 42291-866). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avkare, 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

2.5 (864 30 2.5mg)

This is a description of Tadalafil, USP tablets manufactured by AVKARE for once daily use. Each film-coated tablet contains 25mg of Tadalafil. The usual dosage should be seen in accompanying literature. The tablets should not be split and the entire dose should be taken. They come in a bottle of 30 tablets and should be stored at 20-25°C (68-77°F) with excursions permitted between 15-30°C (59-86°F). It is recommended to keep this medication out of the reach of children and dispense in a tight container. The text includes other manufacturing details and a non-varnish area for some unknown product.*

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5 (865 30 5mg)

This is a description of Tadalafil tablets with NDC code 42291-865-30. The tablets are film-coated and contain 5mg of Tadalafil USP. The usual dosage can be found in the accompanying literature. Tablets should not be split and the entire dose should be taken. The tablets must be stored within a temperature range of 20°C to 25°C (68°F to 77°F), with excursions allowed between 15°C to 30°C (59°F to 86°F). The tablets should be kept out of the reach of children and dispensed in a tight container. The tablets are manufactured for AVKARE located in Pulaski, TN, and there is a non-varnish area for Lot No. and Exp. Date.*

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10 (866 30 10mg)

This is a description of Tadalafil tablets, USP with the drug code NDC 42291-866-30. Each film-coated tablet contains 10mg of Tadalafil, and the usual dosage should be checked in the accompanying literature. Tablets should not be split, and the entire dose should be taken. The medication should be stored at 20° to 25°C (68° to 77°F), and dispensed in a tight container. The manufacturer is AVKARE, and the lot number and expiration date are provided, along with instructions to keep the medication out of reach of children.*

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20 (867 30 20mg)

This is a description of Tadalafil tablets, which come in a 20mg strength per tablet. The label advises not to split the tablet and to take the entire dose. It recommends referring to the accompanying literature for dosage information. The tablets should be stored at room temperature, between 20°C to 25°C (68°F to 77°F), with occasional excursions between 15°C to 30°C (59°F to 86°F). The medication should be kept out of children's reach and dispensed in a tight container. The label also indicates the manufacturer, AVKARE, Pulaski, TN, and includes a lot number and expiration date.*

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10 (Tadalafil Tablets Usp 1)

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10 (Tadalafil Tablets Usp 2)

The text appears to be a table showing the difference in blood pressure (in mmHg) between subjects who were administered Tadalafil and those given a placebo. The table shows measurements for standing and supine systolic and diastolic blood pressure at various time intervals (in hours) after administration. However, the formatting of the text is not easily understandable and the characters are distorted, making it difficult to fully interpret.*

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10 (Tadalafil Tablets Usp 3)

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10 (Tadalafil Tablets Usp 4)

This appears to be a medical chart showing different dosages of tadalafil and doxazosin and their effects on systolic blood pressure at different times after administration. The chart includes dosages of 20mg tadalafil and 8mg doxazosin, as well as a placebo.*

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10 (Tadalafil Tablets Usp 5)

This is a graph showing the concentration of plasma Tadalafil (in mcg/L) over time (in hours) for different doses (20 mg single dose, 5 mg single dose, and 5 mg once-daily dose for five consecutive days). The graph shows the concentration levels up to 120 hours.*

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10 (Tadalafil Tablets Usp 6)

The text describes a graph or table showing the change in IPSS total score with Tadalafil 5 mg and Placebo. The duration of treatment in weeks is also included. The graph or table shows that Tadalafil 5 mg is statistically significant compared to Placebo (*p<0.01).*

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10 (Tadalafil Tablets Usp 7)

This is a graph displaying the change from baseline in IPSS total score in weeks for two groups. One group was given Tadalafil 5 mg and the other group was given Placebo. The asterisk symbol (*) next to p < 0.01 indicates a statistically significant difference between the two groups.*

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10 (Tadalafil Tablets Usp 8)

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10 (Tadalafil Tablets Usp 9)

This is a table showing the comparison between the effects of Tadalafil 5mg and Placebo on the change from Baseline in IPSS Total Score for a certain duration of treatment measured in weeks. The result of the study indicates a significant difference between the two drugs with Tadalafil showing a superior effect.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.