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Keep this medication in the container it came in, tightly closed, and out of reach of children. Store at room temperature and away from excess heat and moisture not in the bathroom.

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The processes of the invention prepare tadalafil having high purity. In particular, the content of the trans-tadalafil impurity 6S, 12aR -2,3,6,7,12,12a- hexahydromethyl 3,4-methylenedioxyphenyl pyrazino[2,1]pyrido[3,4- b]indole-1 ,4-dione having the structure below in the tadalafil Erectile Dysfunction causes is less than about 0. Further, the content of the chiral tadalafil impurity 6S, 12aS - 2,3,6,7,12,12a-hexahydromethyl 3,4-methyleneclioxyphenyl pyrazino [2,1 :6,1]pyrido[3,4-b]indole-1 ,4-dione having the structure below in the tadalafil product of the processes of this invention is less than about 0.

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