| L/2/9'9/438 4, "8+ B+)':8+ 4, 9.+ 7/808 4, '**/)9/43, '(:8+, '3* 2/8:8+ </9. 45/4/*8, +;+3 '9 7+)422+3*+* *48+8, 7+8+7;+ OLIN#$K ,47 :8+ /3 5'9/+398 ,47 <.42 '19+73'9/;+ 97+'92+39 459/438 %+.-., 343-45/4/* '3'1-+8/)8 47 45/4/* )42(/3'9/43 574*:)98&: G H';+ 349 (++3 941+7'9+*, 47 '7+ 349 +=5+)9+* 94 (+ 941+7'9+* G H';+ 349 574;/*+* '*+6:'9+ '3'1-+8/', 47 '7+ 349 +=5+)9+* 94 574;/*+ '*+6:'9+ '3'1-+8/'. !.+ ):2:1'9/;+ 949'1 *'/1> *48+ 8.4:1* 349 +=)++* 27 2-, '8 949'1 *'/1> *48+8 -7+'9+7 9.'3 27 2-2'> /3)7+'8+ 9.+ 7/80 ,47 Q!) /39+7;'1 574143-'9/43. CONTRAINDICATIONS OLIN#$K /8 )4397'/3*/)'9+* /3 5'9/+398 </9.: • /-3/,/)'39 7+85/7'947> *+57+88/43 • A):9+ 47 8+;+7+ (743)./'1 '89.2' /3 '3 :3243/947+* 8+99/3-47 /3 9.+ '(8+3)+ 4, 7+8:8)/9'9/;+ +6:/52+39 • K34<3 47 8:85+)9+* -'8974/39+89/3'1 4(897:)9/43, /3)1:*/3-5'7'1>9/) /1+:8 • K34<3 .>5+78+38/9/;/9> 94 41/)+7/*/3+ (+.-., '3'5.>1'=/8) WARNINGS AND PRECAUTIONS • OLIN#$K )439'/38 41/)+7/*/3+, ' ).+*:1+ [controlled substance schedule pending] )4397411+* 8:(89'3)+, 9.'9 +=548+8 :8+78 94 9.+ 7/808 4, '**/)9/43, '(:8+, '3* 2/8:8+. A19.4:-. 9.+ 7/80 4, '**/)9/43 /3 '3> /3*/;/*:'1 /8 :3034<3, /9 )'3 4)):7 /3 5'9/+398 '557457/'9+1> 57+8)7/(+* OLIN#$K. A88+88 7/80, )4:38+1, '3* 243/947 '11 5'9/+398 7+)+/;/3-45/4/*8. • +7/4:8, 1/,+-9.7+'9+3/3-7+85/7'947> *+57+88/43 .'8 (++3 7+5479+* </9. 9.+ :8+ 4, 45/4/*8, +;+3 <.+3 :8+* '8 7+)422+3*+*, +85+)/'11> /3 5'9/+398 </9. ).743/) 5:1243'7> */8+'8+, 47 /3 +1*+71>, )').+)9/) '3* *+(/1/9'9+* 5'9/+398. !.+ 7/80 /8 -7+'9+89 *:7/3-/3/9/'9/43 4, OLIN#$K 9.+7'5>, ,4114</3-' *48+ /3)7+'8+, 47 <.+3 :8+* </9. 49.+7 *7:-8 9.'9 *+57+88 7+85/7'9/43. P745+7 *48/3-4, OLIN#$K /8 +88+39/'1, +85+)/'11> <.+3 )43;+79/3-5'9/+398 ,742 '349.+7 45/4/* 574*:)9 94 ';4/* 4;+7*48+. M'3'-+2+39 4, 7+85/7'947> *+57+88/43 2'> /3)1:*+ )148+ 4(8+7;'9/43, 8:55479/;+ 2+'8:7+8, '3* :8+ 4, 45/4/* '39'-43/898, *+5+3*/3-43 9.+ 5'9/+39A8 )1/3/)'1 89'9:8. • O5/4/*8 )'3 )':8+ 81++5-7+1'9+* (7+'9./3-*/847*+78 /3)1:*/3-)+397'1 81++5 '53+' (C A) '3* 81++5-7+1'9+* .>54=+2/' </9. 7/80 /3)7+'8/3-/3 ' *48+-*+5+3*+39 ,'8./43. I3 5'9/+398 <.4 57+8+39 </9. C A, )438/*+7 *+)7+'8/3-9.+ *48+ 4, 45/4/* :8/3-(+89 57')9/)+8 ,47 45/4/* 9'5+7. INDICATIONS AND USAGE OLIN#$K /8 ' 3+< ).+2/)'1 +39/9> /3*/)'9+* /3 '*:198 ,47 9.+ 2'3'-+2+39 4, '):9+ 5'/3 8+;+7+ +34:-. 94 7+6:/7+ '3 /397';+34:8 45/4/* '3'1-+8/) '3* ,47 <.42 '19+73'9/;+ 97+'92+398 '7+ /3'*+6:'9+. 40 WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; ,# RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS A##("2(-,, A!31$, ,# M(131$ OLINVYK $6.-1$1 . 2($,21 ,# -2'$0 31$01 2-2'$ 0(1)1 -% -.(-(# ##("2(-,, !31$, ,# +(131$, 5'("' " , *$ # 2--4$0#-1$ ,# #$ 2'. A11$11 $ "' . 2($,291 0(1) !$%-0$ .0$1"0(!(,& OLINVYK, ,# +-,(2-0 ** . 2($,21 0$&3* 0*7 %-0 2'$ #$4$*-.+$,2 -% !$' 4(-01 -0 "-,#(2(-,1. L(%$-T'0$ 2$,(,& R$1.(0 2-07 D$.0$11(-, S$0(-31, *(%$-2'0$ 2$,(,&, -0 % 2 * 0$1.(0 2-07 #$.0$11(-, + 7 -""30 5(2' 31$ -% OLINVYK. M-,(2-0 %-0 0$1.(0 2-07 #$.0$11(-,, $1.$"( **7 #30(,& (,(2( 2(-, -% OLINVYK -0 %-**-5(,& #-1$ (,"0$ 1$. N$-, 2 * O.(-(# W(2'#0 5 * S7,#0-+$ P0-*-,&$# 31$ -% OLINVYK #30(,& .0$&, ,"7 " , 0$13*2 (, ,$-, 2 * -.(-(# 5(2'#0 5 * 17,#0-+$, 5'("' + 7 !$ *(%$-2'0$ 2$,(,& (% ,-2 0$"-&,(8$# ,# 20$ 2$#, ,# 0$/3(0$1 + , &$+$,2 ""-0#(,& 2-.0-2-"-*1 #$4$*-.$# !7 ,$-, 2-*-&7 $6.$021. I% -.(-(# 31$ (1 0$/3(0$# %-0 .0-*-,&$# .$0(-# (, .0$&, ,2 5-+ ,, #4(1$ 2'$ . 2($,2 -% 2'$ 0(1) -% ,$-, 2 * -.(-(# 5(2'#0 5 * 17,#0-+$ ,# $,130$ 2' 2 ..0-.0( 2$ 20$ 2+$,2 5(** !$ 4 (* !*$. R(1) F0-+ C-,"-+(2 ,2 U1$ W(2' B$,8-#( 8$.(,$1 -0 O2'$0 CNS D$.0$11 ,21 C-,"-+(2 ,2 31$ -% -.(-(#1 5(2' !$,8-#( 8$.(,$1 -0 -2'$0 CNS #$.0$11 ,21, (,"*3#(,& *"-'-*, + 7 0$13*2 (, .0-%-3,# 1$# 2(-,, 0$1.(0 2-07 #$.0$11(-,, "-+ , ,# #$ 2'. R$1$04$ "-,"-+(2 ,2 .0$1"0(!(,& %-0 31$ (, . 2($,21 %-0 5'-+ *2$0, 2(4$ 20$ 2+$,2 -.2(-,1 0$ (, #$/3 2$; *(+(2 #-1 &$1 ,# #30 2(-,1 2-2'$ +(,(+3+ 0$/3(0$#; ,# %-**-5 . 2($,21 %-0 1(&,1 ,# 17+.2-+1 -% 0$1.(0 2-07 #$.0$11(-, ,# 1$# 2(-,. |