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Dose Dosing: 2.5 mg once daily. Storage And Handling. 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 2½” Blisters of 2 x 15 NDC 0002-4465-34.

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5 mg tablets debossed with “C 5” Bottles of 30 NDC 0002-4462-30 Blisters of 2 x 15 NDC 0002-4462-34. 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. Storage. Store at 25°C (77°F); excursions permitted to 15-50°C (59-86°F) [see USP Controlled Room Temperature ]. Keep out of reach of children. Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA Revised: Feb 2018. SLIDESHOW.

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SIDE EFFECTS. Clinical Trials Experience. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Tadalafil was administered to over 9000 men during clinical trials worldwide. In trials of CIALIS for once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively.

For CIALIS for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively. CIALIS For Use As Needed For ED. In eight primary placebo-controlled clinical studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and the discontinuation rate due to adverse events in patients treated with tadalafil 10 or 20 mg was 3.1%, compared to 1.4% in placebo treated patients. When taken as recommended in the placebo-controlled clinical trials, the following adverse reactions were reported (see Table 1) for CIALIS for use as needed: Table 1: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with CIALIS (10 or 20 mg) and More Frequent on Drug than Placebo in the Eight Primary Placebo-Controlled Clinical Studies (Incomplete Use) for CIALIS for Use as Needed for ED Adverse Reaction Placebo (Incomplete Use) Tadalafil 5 mg Tadalafil 10 mg Tadalafil 20 mg (Day 1) (Incomplete use) (Incomplete use) (Incomplete use) (Incomplete use) (Incomplete use) (Incomplete use) (Incomplete use) (Incomplete use) (Incomplete use) (Incomplete use) (Incomplete use) (Incomplete use) (Incomplete use) (Incomplete use) (Incomplete use) (Incomplete use)

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