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 is 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 is 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 )] .
ajanta pharma limited
OVAL YELLOW T 5
T 5 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Tadalafil Tablets, USP are supplied as follows: 2.5 mg: Light yellow to yellow colored, oval-shaped, film-coated tablets, debossed with “T2 1/2 ” on one side and plain on other side. Bottle of 30 NDC 27241-111-03 Bottle of 500 NDC 27241-111-05 5 mg: Light yellow to yellow colored, oval-shaped, film-coated tablets, debossed with “T5” on one side and plain on other side. Bottle of 30 NDC 27241-112-03 Bottle of 500 NDC 27241-112-05 10 mg: Light yellow to yellow colored, oval-shaped, film-coated tablets, debossed with “T10” on one side and plain on other side. Bottle of 30 NDC 27241-113-03 Bottle of 500 NDC 27241-113-05 20 mg: Light yellow to yellow colored, oval-shaped, film-coated tablets, debossed with “T20” on one side and plain on other side. Bottle of 30 NDC 27241-114-03 Bottle of 500 NDC 27241-114-05 16.2 Storage Store at 20° to 25°C (68° to 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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