Advise patients not to breastfeed if they are taking ADDYI [see Use in Specific Populations (8.2)]. Bedtime Dosing Advise patients to take only one tablet at bedtime and not to take ADDYI at any other time of day [see Dosage and Administration (2)]. Distributed by: Sprout Pharmaceuticals, Inc. Raleigh, NC 27609 USA Product and trademark licensed from: Sprout Pharmaceuticals, Inc. Copyright 2019 Sprout Pharmaceuticals, Inc. ALL RIGHTS RESERVED ADDYI tablets are covered by U.S. Patents Nos. 7,151,103; 7,420,057; 7,183,410; 8,227,471; 9,468,639; and 9,782,403. IT5046AJ0909 10005639/01 Reference ID: 4865026