tadalafil tablet film coated
1 INDICATIONS AND USAGE Tadalafil tablets are 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 decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil beyond 26 weeks is unknown [ see Clinical Studies ( 14.3 ) ].
zydus pharmaceuticals (usa) inc.
OVAL YELLOW 897
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied:
TADALAFIL Tablets USP, 2.5 mg are white colored, capsule shape, biconvex, film-coated tablets debossed 'T 1' on one side and plain on the other side and are supplied as follows: NDC 68382-896-06 in bottle of 30 tablets with child-resistant closure NDC 68382-896-16 in bottle of 90 tablets with child-resistant closure NDC 68382-896-01 in bottle of 100 tablets NDC 68382-896-05 in bottle of 500 tablets NDC 68382-896-10 in bottle of 1000 tablets NDC 68382-896-99 in child resistant cartons of 30 tablets (2 x 15 unit dose)
TADALAFIL Tablets USP, 5 mg are yellow colored, oval shape, biconvex with bevel edge, film-coated tablets debossed '897' on one side and plain on the other side and are supplied as follows: NDC 68382-897-50 in bottle of 10 tablets with child-resistant closure NDC 68382-897-06 in bottle of 30 tablets with child-resistant closure NDC 68382-897-16 in bottle of 90 tablets with child-resistant closure NDC 68382-897-01 in bottle of 100 tablets NDC 68382-897-05 in bottle of 500 tablets NDC 68382-897-10 in bottle of 1000 tablets NDC 68382-897-99 in child resistant cartons of 30 tablets (2 x 15 unit dose)
TADALAFIL Tablets USP, 10 mg are yellow colored, capsule shape, biconvex, film-coated tablets debossed '898' on one side and plain on the other side and are supplied as follows: NDC 68382-898-06 in bottle of 30 tablets with child-resistant closure NDC 68382-898-16 in bottle of 90 tablets with child-resistant closure NDC 68382-898-01 in bottle of 100 tablets NDC 68382-898-05 in bottle of 500 tablets NDC 68382-898-10 in bottle of 1000 tablets NDC 68382-898-99 in child resistant cartons of 30 tablets (2 x 15 unit dose)
TADALAFIL Tablets USP, 20 mg are yellow colored, oval shape, biconvex with bevel edge, film-coated tablets debossed '899' on one side and plain on the other side and are supplied as follows: NDC 68382-899-06 in bottle of 30 tablets with child-resistant closure NDC 68382-899-16 in bottle of 90 tablets with child-resistant closure NDC 68382-899-01 in bottle of 100 tablets NDC 68382-899-05 in bottle of 500 tablets NDC 68382-899-10 in bottle of 1000 tablets NDC 68382-899-99 in child resistant cartons of 30 tablets (2 x 15 unit dose) 16.2 Storage Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
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