tadalafil 10 mg
1 INDICATIONS AND USAGE Tadalafil tablet 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 )].
nivagen pharmaceuticals, inc.
TEAR YELLOW T10
T10 TEAR 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 almond-shaped tablets are available in yellow color and different sizes, and supplied in the following package sizes: 2.5 mg tablets debossed with “TAD” Bottle of 30 with child-resistant closure, NDC 75834-247-30 Bottle of 1000 NDC 75834-247-01 Blisters of 2 x 15 NDC 75834-247-15 5 mg tablets debossed with “T5” Bottle of 30 with child-resistant closure, NDC 75834-248-30 Bottle of 1000 NDC 75834-248-01 Blisters of 2 x 15 NDC 75834-248-15 10 mg tablets debossed with “T10” Bottle of 30 with child-resistant closure, NDC 75834-249-30 Bottle of 1000 NDC 75834-249-01 Blisters of 3 x 10 NDC 75834-249-10 20 mg tablets debossed with “T20” Bottle of 30 with child-resistant closure, NDC 75834-250-30 Bottle of 1000 NDC 75834-250-01 Blisters of 3 x 10 � NDC 75834-250-10 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]. Bottle of 30s package is child resistant. Keep out of reach of children.
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