tadalafil 2.5 MG Oral Tablet
1 INDICATIONS AND USAGE Tadalafil tablets are 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 tablets decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets beyond 26 weeks is unknown [see Clinical Studies (14.3) ] .
Mylan Pharmaceuticals Inc.
ROUND YELLOW M TL 1
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tadalafil Tablets, USP are available containing 2.5 mg, 10 mg or 20 mg of tadalafil, USP. The 2.5 mg tablets are light yellow, film-coated, round, unscored tablets debossed with M on one side of the tablet and TL over 1 on the other side. They are available as follows: NDC 0378-6970-93 bottles of 30 tablets NDC 0378-6970-77 bottles of 90 tablets NDC 0378-6970-01 bottles of 100 tablets NDC 0378-6970-85 carton of 30 tablets (two blister cards x 15 tablets) The 10 mg tablets are light yellow, film-coated, round, unscored tablets debossed with M on one side of the tablet and TL3 on the other side. They are available as follows: NDC 0378-6972-93 bottles of 30 tablets NDC 0378-6972-77 bottles of 90 tablets NDC 0378-6972-01 bottles of 100 tablets The 20 mg tablets are light yellow, film-coated, round, unscored tablets debossed with M on one side of the tablet and TL4 on the other side. They are available as follows: NDC 0378-6973-93 bottles of 30 tablets NDC 0378-6973-91 bottles of 60 tablets NDC 0378-6973-77 bottles of 90 tablets NDC 0378-6973-80 bottles of 180 tablets NDC 0378-6973-05 bottles of 500 tablets 16.2 Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep out of reach of children. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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