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1 INDICATIONS AND USAGE CIALIS ® 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 CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 erectile dysfunction CIALIS ® is indicated for the treatment of erectile dysfunction (ED). 1.2 benign prostatic hyperplasia CIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 erectile dysfunction and benign prostatic hyperplasia CIALIS is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). 1.4 Limitation of Use If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown [see Clinical Studies ( 14.3 )] .
eli lilly and company
TEAR YELLOW C 5
C 5 TEAR YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied CIALIS (
TADALAFIL) is supplied as follows: Four strengths of almond-shaped tablets are available in different sizes and different shades of yellow, and supplied in the following package sizes: 2.5 mg tablets debossed with “C 2 1/2” Blisters of 2 x 15 NDC 0002-4465-34 5 mg tablets debossed with “C 5” Bottles of 30 NDC 0002-4462-30 10 mg tablets debossed with “C 10” Bottles of 30 NDC 0002-4463-30 20 mg tablets debossed with “C 20” Bottles of 30 NDC 0002-4464-30 16.2 Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.
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