tadalafil 5 mg
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 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)] .
sun pharmaceutical industries, inc.
OVAL YELLOW S 5
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
TADALAFIL tablets, USP are supplied as follows: 2.5 mg tablets are yellow colored, round shaped, biconvex, film-coated tablets, debossed with “2½” on one side and plain on other side. They are supplied in the following package sizes: Unit-dose blister pack of 30 (2 × 15) tablets ……………….………….. NDC 47335-009-64 5 mg tablets are yellow colored, oval shaped, biconvex, film-coated tablets, debossed with “5” on one side and “S” on other side. They are supplied in the following package sizes: Bottles of 30’s with Child Resistant Closure ……………….……..….... NDC 47335-010-83 Unit-dose blister pack of 30 (2 × 15) tablets ……………….………….. NDC 47335-010-64 10 mg tablets are yellow colored, oval shaped, biconvex, film-coated tablets, debossed with “10” on one side and “S” on other side. They are supplied in the following package sizes: Bottles of 30’s with Child Resistant Closure ……………….……..….... NDC 47335-011-83 20 mg tablets are yellow colored, oval shaped, biconvex, film-coated tablets, debossed with “20” on one side and “S” on other side. They are supplied in the following package sizes: Bottles of 30’s with Child Resistant Closure ……………….……..….... NDC 47335-012-83 16.2 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
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