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tadalafil 20 mg

1 INDICATIONS AND USAGE Tadalafil Tablets 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 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 )] .

Unichem Pharmaceuticals (USA), Inc.


11 months ago TEAR YELLOW U 289 tadalafil 20 mg

TEAR YELLOW U 289

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied

TADALAFIL Tablets USP are supplied as follows:

TADALAFIL Tablets USP, 2.5 mg Light orange color, oval shaped film coated tablets debossed with "286" on one side of the tablet and "U" on other side of tablet. Bottle of 30 29300-286-13 Bottle of 100 29300-286-01 Bottle of 500 29300-286-05 Carton of 30 tablets (2 cards of 15 tablets) 29300-286-82

TADALAFIL Tablets USP, 5 mg yellow color, almond shaped film coated tablets debossed with "287" on one side of the tablet and "U" on other side of tablet. Bottle of 30 29300-287-13 Bottle of 100 29300-287-01 Bottle of 500 29300-287-05 Carton of 30 tablets (2 cards of 15 tablets) 29300-287-82

TADALAFIL Tablets USP, 10 mg Light orange colored, almond shaped film coated tablets, debossed with "288" on one side of the tablet and "U" on other side of tablet. Bottle of 30 29300-288-13 Bottle of 100 29300-288-01 Bottle of 500 29300-288-05

TADALAFIL Tablets USP, 20 mg yellow color, almond shaped tablets film coated tablets debossed with "289" on one side of the tablet and "U" on other side of tablet. Bottle of 30 29300-289-13 Bottle of 100 29300-289-01 Bottle of 500 29300-289-05 16.2 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep this and all drugs out of reach of children.


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Unichem Pharmaceuticals (USA), Inc.












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