tadalafil tablet film coated
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 )] .
apotex corp.
ROUND YELLOW 47
47 ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tadalafil Tablets, USP are supplied as follows: Four strengths of round, pale yellow to yellow tablets are available in different sizes, and supplied in the following package sizes: 2.5 mg tablets debossed with “43” Bottles of 30 NDC 60505-4683-3 5 mg tablets debossed with “44” Bottles of 30 NDC 60505-4684-3 10 mg tablets debossed with “45” Bottles of 30 NDC 60505-4685-3 20 mg tablets debossed with “47” Bottles of 30 NDC 60505-4686-3 16.2 Storage Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
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