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 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 )] .
vkt pharma private limited
OVAL YELLOW V 5
V 5 OVAL 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 yellow coloured, oval-shaped tablets are available in different sizes and supplied in the following package sizes:
TADALAFIL tablets, USP, 2.5 mg: 2.5 mg tablets debossed with ‘2.5’ on one side and “V” on the other side. Blisters of 2 x 15 NDC 71821-006-01
TADALAFIL tablets, USP, 5 mg: 5 mg tablets debossed with ‘5’ on one side and “V” on the other side. Blisters of 2 x 15 NDC 71821-007-01 Bottles of 30 NDC 71821-007-02
TADALAFIL tablets, USP, 10 mg: 10 mg tablets debossed with ‘10’ on one side and “V” on the other side. Bottles of 30 NDC 71821-008-01
TADALAFIL tablets, USP, 20 mg: 20 mg tablets debossed with ‘20’ on one side and “V” on the other side. Bottles of 30 NDC 71821-009-01 16.2 Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
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