tadalafil 20 MG Oral Tablet
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 )] .
cipla usa inc.
OVAL YELLOW Cipla 376
Cipla 376 OVAL YELLOW
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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: Cream coloured, circular, biconvex film coated tablet with "C" debossed on one side and '373' on other side. NDC 69097-373-94 Blisters cards of 2 x 15 NDC 69097-373-02 Bottles of 30 with child resistant closure NDC 69097-373-05 Bottles of 90 with child resistant closure NDC 69097-373-15 Bottles of 1000
TADALAFIL tablets, USP, 5 mg: Cream coloured, circular, biconvex film coated tablet with "C" debossed on one side and '374' on other side. NDC 69097-374-94 Blisters cards of 2 x 15 NDC 69097-374-02 Bottles of 30 with child resistant closure NDC 69097-374-05 Bottles of 90 with child resistant closure NDC 69097-374-15 Bottles of 1000
TADALAFIL tablets, USP, 10 mg: yellow coloured, capsule shaped, biconvex film coated tablet with "Cipla" debossed on one side and '375' on other side. NDC 69097-375-02 Bottles of 30 with child resistant closure NDC 69097-375-05 Bottles of 90 with child resistant closure NDC 69097-375-15 Bottles of 1000
TADALAFIL tablets, USP, 20 mg: yellow coloured, capsule shaped, biconvex film coated tablet with "Cipla" debossed on one side and '376' on other side. NDC 69097-376-02 Bottles of 30 with child resistant closure NDC 69097-376-05 Bottles of 90 with child resistant closure NDC 69097-376-15 Bottles of 1000 16.2 Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
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