tadalafil 2.5 mg
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 is 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) ] .
amneal pharmaceuticals ny llc
ROUND WHITE C1
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
TADALAFIL Tablets USP, 2.5 mg are supplied as white to off-white, round, biconvex, film-coated tablets debossed with “C1” on one side and plain on the other. They are available as follows: Bottles of 30: NDC 69238-1346-3
TADALAFIL Tablets USP, 5 mg are supplied as yellow colored, round, biconvex, film-coated tablets debossed with “A13” on one side and plain on the other. They are available as follows: Bottles of 30: NDC 69238-1347-3
TADALAFIL Tablets USP, 10 mg are supplied as yellow colored, round, biconvex, film-coated tablets debossed with “AC” above “06” on one side and plain on the other. They are available as follows: Bottles of 30: NDC 69238-1348-3
TADALAFIL Tablets USP, 20 mg are supplied as yellow colored, oval, biconvex, film-coated tablets debossed with “AA” on one side and “09” on the other. They are available as follows: Bottles of 30: NDC 69238-1349-3 16.2 Storage Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Keep this and all medications out of reach of children.
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