tadalafil 5 mg
1 INDICATIONS AND USAGE Tadalafil tablets USP are 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 USP 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 USP are indicated for the treatment of erectile dysfunction (ED). 1.2 benign prostatic hyperplasia Tadalafil tablets USP 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 USP are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). 1.4 Limitation of Use If tadalafil tablets USP are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets USP decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets USP beyond 26 weeks is unknown [see Clinical Studies (14.3)] .
Alembic Pharmaceuticals Inc.
ROUND YELLOW 337
337 ROUND YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
TADALAFIL tablets USP 2.5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘336’ on one side and plain on other side. NDC Number Size 62332-177-30 bottle of 30 Tablets 62332-177-15 30 Tablets (2 blisters of 15 tablets)
TADALAFIL tablets USP 5 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘337’ on one side and plain on other side. NDC Number Size 62332-178-30 bottle of 30 Tablets 62332-178-15 30 Tablets (2 blisters of 15 tablets)
TADALAFIL tablets USP 10 mg are yellow to light yellow, round shaped, beveled edge, coated tablets debossed with ‘338’ on one side and plain on other side. NDC Number Size 62332-179-30 bottle of 30 Tablets
TADALAFIL tablets USP 20 mg are yellow to light yellow, oval shaped, beveled edge, coated tablets debossed with ‘L339’ on one side and plain on other side. NDC Number Size 62332-180-30 bottle of 30 Tablets 16.2 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
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