tadalafil 5 mg
1 INDICATIONS & 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 tablet is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 erectile dysfunction Tadalafil tablet is indicated for the treatment of erectile dysfunction (ED). 1.2 benign prostatic hyperplasia Tadalafil tablet is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 erectile dysfunction and benign prostatic hyperplasia Tadalafil tablet is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). 1.4 Limitation of Use If tadalafil tablet is 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 )].
camber pharmaceuticals, inc.
ROUND WHITE T17 H
T17 H ROUND WHITE
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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 blue color, round shaped, biconvex, film-coated tablets debossed with 'T18' on one side and 'H' on the other side. Bottles of 30 tablets NDC 31722-643-30 Carton of 30 (3×10) unit-dose tablets NDC 31722-643-31
TADALAFIL tablets USP, 5 mg are white color, round shaped, biconvex, film-coated tablets debossed with 'T17' on one side and 'H' on the other side. Bottles of 30 tablets NDC 31722-644-30 Carton of 30 (3×10) unit-dose tablets NDC 31722-644-31
TADALAFIL tablets USP, 10 mg are white color, capsule shaped, biconvex, film-coated tablets debossed with 'T16' on one side and 'H' on the other side. Bottles of 30 tablets NDC 31722-645-30 Carton of 100 (10×10) unit-dose tablets NDC 31722-645-31
TADALAFIL tablets USP, 20 mg are white color, capsule shaped, biconvex, film-coated tablets debossed with 'T15' on one side and 'H' on the other side. Bottles of 30 tablets NDC 31722-646-30 Carton of 100 (10×10) unit-dose tablets NDC 31722-646-31 16.2 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Keep out of reach of children.
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