tadalafil tablet film coated
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 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) ].
aurobindo pharma limited
OVAL YELLOW L 58
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
TADALAFIL tablets USP are supplied as follows:
TADALAFIL Tablets USP 2.5 mg are light orange-yellow colored, oval shaped, film-coated tablets debossed with ‘1’ on one side and ‘L’ on the other side. Bottles of 30 NDC 65862-850-30 Cartons of 30 (2x15 Unit-dose Tablets) NDC 65862-850-32
TADALAFIL Tablets USP 5 mg are light yellow colored, oval shaped, film-coated tablets debossed with ‘56’ on one side and ‘L’ on the other side. Bottles of 30 NDC 65862-851-30 Cartons of 30 (2x15 Unit-dose Tablets) NDC 65862-851-32
TADALAFIL Tablets USP 10 mg are light yellow colored, oval shaped, film-coated tablets debossed with ‘57’ on one side and ‘L’ on the other side. Bottles of 30 NDC 65862-852-30 Bottles of 500 NDC 65862-852-05 Bottles of 1,000 NDC 65862-852-99
TADALAFIL Tablets USP 20 mg are yellow colored, oval shaped, film-coated tablets debossed with ‘58’ on one side and ‘L’ on the other side. Bottles of 30 NDC 65862-853-30 Bottles of 500 NDC 65862-853-05 Bottles of 1,000 NDC 65862-853-99 16.2 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
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