tadalafil 20 MG Oral Tablet
1 INDICATIONS AND USAGE Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1 ) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 erectile dysfunction Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED). 1.2 benign prostatic hyperplasia Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 erectile dysfunction and benign prostatic hyperplasia Tadalafil tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). 1.4 Limitation of Use If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is unknown [see Clinical Studies ( 14.3 )] .
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OVAL YELLOW FJ4
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
TADALAFIL tablets, USP 2.5 mg are available for oral administration as off white to pale yellow coloured, almond shaped, biconvex, film coated tablets debossed with “FJ1” on one side and plain on other side Bottles of 30 count comes in a child-resistant package (NDC 16729-369-10) Bottles of 90 count comes in a child-resistant package (NDC 16729-369-15) Bottles of 500 count (NDC 16729-369-16) Bottles of 1000 count (NDC 16729-369-17) Carton of 30 (Blisters of 2 x 15) (NDC 16729-369-97)
TADALAFIL tablets, USP 5 mg are available for oral administration as light yellow coloured, almond shaped, biconvex, film coated tablets debossed with “FJ2” on one side and plain on other side Bottles of 30 count comes in a child-resistant package (NDC 16729-370-10) Bottles of 90 count comes in a child-resistant package (NDC 16729-370-15) Bottles of 500 count (NDC 16729-370-16) Bottles of 1000 count (NDC 16729-370-17) Carton of 30 (Blisters of 2 x 15) (NDC 16729-370-97)
TADALAFIL tablets, USP 10 mg are available for oral administration as yellow coloured, almond shaped, biconvex, film coated tablets, debossed with “FJ3” on one side and plain on other side Bottles of 30 count comes in a child-resistant package (NDC 16729-371-10) Bottles of 90 count comes in a child-resistant package (NDC 16729-371-15) Bottles of 500 count (NDC 16729-371-16) Bottles of 1000 count (NDC 16729-371-17)
TADALAFIL tablets, USP 20 mg are available for oral administration as yellow coloured, almond shaped, biconvex, film coated tablets, debossed with “FJ4” on one side and plain on other side Bottles of 30 count comes in a child-resistant package (NDC 16729-372-10) Bottles of 90 count comes in a child-resistant package (NDC 16729-372-15) Bottles of 500 count (NDC 16729-372-16) Bottles of 1000 count (NDC 16729-372-17) 16.2 Storage Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
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