tadalafil tablet 10 mg 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 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 )].
teva pharmaceuticals usa, inc.
OVAL YELLOW Teva 3018
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
TADALAFIL tablets, USP are available as follows: 2.5 mg: light yellow, round, film-coated tablets, debossed with “TEVA” on one side of the tablet and with “3016” on the other side, in the following package sizes: Bottles of 30 (NDC 0093-3016-56) Unit-Dose Boxes of 30 (2 cards of 15 tablets) (NDC 0093-3016-65) 5 mg: yellow, round, film-coated tablets, debossed with “TEVA” on one side of the tablet and with “3017” on the other side, in the following package sizes: Bottles of 30 (NDC 0093-3017-56) Unit-Dose Boxes of 30 (2 cards of 15 tablets) (NDC 0093-3017-65) 10 mg: yellow, oval-shaped, film-coated tablets, debossed with “TEVA” on one side of the tablet and with “3018” on the other side, in bottles of 30 (NDC 0093-3018-56). 20 mg: yellow, oval-shaped, film-coated tablets, debossed with “TEVA” on one side of the tablet and with “3019” on the other side, in bottles of 30 (NDC 0093-3019-56). 16.2 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep this and all medications out of the reach of children.
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