`
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`INS H01 LON ' 31dWV$
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`$13|q21(3UIZBU8q9J181l18p)
`opaqsnv
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`0L‘Z8 L'917989 DCIN
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`{##1## 101
`MW WdX3
`
`
`
`NDC 68546-18270
`
`NDC 68546-18270
`
`NDC 68546-182-70
`
`RX Only
`
`NDC 685464 82-70
`
`Tardive Dyskinesia
`4 Week Patient Titration Kit
`12 mg Starting Dose
`
`
`
`Austedo
`Austedo
`Austedo
`Austedo
`(deutetrabenazine) tablets
`(deute
`enazine))tablets
`(deute abenazine) tablets
`(d
`etrabenazine) tablets
`
`
`To learn more about patient support services
`and financial assistance. scan the code below.
`call 1—800—887—8100, or visit TDPatientAssist.com.
`
`.
`
`Usual Dosage: See full Prescribing
`'"fOrmat'on-swallomabletwmlsv
`d° ”MW ”“5” 0' break-
`Storage muons: Store at 25° c (77" F);
`excursions permitted to 15'—30' C (SW—86° F).
`Protect from lIght and mulsture. Keep out of
`reach of children.
`
`
`
`
`Wuk lT-blm per day
`
`
`lTake 1 (6 mg) tablet every morning and l (6 mg)tablet every evening
`1
`NO ART WORK
`
`
`2
`lTake 1(9 mg] tablet every momIng and l (9 mg)tablet every evening
`
`3
`lTake 1 (12 mg)tabiet every morning and l (12 mgltablet every evening
`4
`Take 2 tablet: every morning (one 9 mg tablet and one 6 mg tablet)» and
`
`Take 2 table: every evening {one 9 mg tablet and one 6 mg tablet]
`
`SAMPLE- NOT FORSALE
`
`Medlcatlon Gulde Requlred: Each time AUSTEDO is
`dispensed. give the patient the accompanying Medication Guide.
`
`Dlspense In thls sealed carton.
`
`
`
`
`teva
`
`
`
`Dlstrlbuted by:
`Teva Pharmaceuticals USA. Inc.
`Parslppany. NJ 07054
`Rev. 11/2020
`
`N3
`
`Monthly carbon contains 70 tablets in 3 child-resistant packs
`including, 28 purple tablets, each containing 6 mg of
`deutetrabenazine, 28 blue tablets. each containing 9 mg
`of deutetrabenazine, and 14 beige tablets. each containing
`12 mg of deutetrabenazine.
`
`
`
`
`
`68546-182-70 I.
`
`
`
`
`
`
`
`513;:1801'JDN '31dWVS
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`NDC 68546-18149
`NDC 68546-18149
`NDC 68546-18149
`
`
`
`
`NDC 68546—18149
`
`
`
`
`
`
`
`
`
`Austedo
`Austedo
`Austedo
`
`(dwieirabenazineitablets
`(deutetiabenazine)ta)b|ets
`(deutetrabenazine) tablets
`
`
`Usual Dosage: See full
`
`
`To learn more about patient support services
`
`Prescribing Information.
`and financial assistance. scan the code below,
`Swallow tablet whole,
`
`
`
`
`call 1-800—887-8100, or visit HDPatientAssisLoom.
`do not chew, crush. or break.
`
`Storage Condltlona:
`
`Store at 25' c (77' F);
`excursions permitted to
`
`15'-30' c (59-86” F).
`Protect from light and
`moisture. Keep out of
`reach of children.
`
`
`
`NO ART WORK
`
`
`Medlcaflon Glide Rewlred: Each time AUSTEDO ls
`
`
`dispensed. give the patient the accompanying Medication Guide.
`
`
`
`
`
`Monthly carton contains 49 td)lets In 2 mild-resbtant packs
`
`including, 8. purple tablets. each containing 6 mg of
`deutetrabenazine, 14 blue tdalets. each contdning 9 mg of
`deutetrabenazine, and 14 beige tables, each containing
`
`
`
`nlstrlh
`12 mg ofdeutetrdaenazlne.
`Iby:
`
`Teva Pharmaceuticals USA. Inc.
`Parslpparly. NJ 07054
`N
`
`Rev.11!2020
`68566-181-69 3
`
`
`
`
`
`
`
`Usual Dosage: See full Prescribing Information.
`Swallow tablet whole. do not chew. crush. or break.
`
`Store at 25' c (77' F); excursions permitted t015'-30' C (59'-86' F).
`Protect from light md moisture.
`Keep out of reach of children.
`
`
`
`
`
`
`
`0303/117‘9?!7901.0f‘N'ilueddgsmd
`
`NO ART WORK
`
`
`
`
`'aui'vsns1aopnaaemque/ial:Kqpaznqgnsga
`
`
`
`
`
`NDC 68546-177-21
`
`I
`
`(deutetrabenazine) tablets
`
`SAMPLE - NOT FORSALE
`
`button
`Press& hold 0
`Pull out card
`
`Medlcauon Gulde Requlred: Each time AUSTEDO is
`dispensed. give the patient the accompanying Medication Guide.
`
`1 tablet dBpenser containing 21 tablets in the following order.
`0 Week 1: 7 purple tablets conia'ning 6 mg deutetruzenazine
`0 Week 2: 14 purple tablets containing 6 mg deutetrabenazine
`
`NO ART WORK
`
`NO ART WORK
`
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`NO ART WORK
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`NO ART WORK
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`
`Huntington's disease Titration Pack
`Week 3 and Week 4
`
`0Pull uutcard
`
`NO ART WORK
`
`NO ART WORK
`
`NO ART WORK
`Extended Label Area
`
`NO ART WORK
`
`NO ART WORK
`
`Chorea associated with
`
`(deutetrabenazine) tablets
`
`9mg and 12mg
`
`Pressa. hold
`button
`
`
`
`Day‘IS—Day16—Day‘I7—Day18—Day19—Day20—Day21
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`
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`
`
`
`
`
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`
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`
`Day22—Day23—Day24—Day25—Day26—Day27—Day28
`
`OO OO OO OO
`
`NO ART WORK
`
`NO ART WORK
`
`NO ART WORK
`
`(0
`
`0]
`
`Rev. "/2020
`
`Distributed by
`Teva Pharmaceuticals USA. Int.
`Parsippany. NJ 07054
`
`Rev. "/2020
`
`Distributed by.
`Teva Pharmaceuticals USA. Int;
`Parsippany. NJ 07054
`
`Rev. “/2020
`
`Distributed by:
`Teva Pharmaceuticals USA, Inc.
`Parsippany. NJ 07054
`
`OOOO
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`######### M M M/YYYY
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`
`
`
`Usual Dosage: See full Prescribing Information.
`Swallow tablet whole. do not chew. crush. or break.
`
`NDC 68546-176-28
`
`Store at 25’ C (77° F); excursions permitted to 15°—30' C (59—86” F).
`Protect from Light and moisture.
`Keep out of reach of children.
`
`
`
`OZOZ/II7‘9879010[N‘I‘UdeEJQd
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`
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`‘oui'VSfls1eapnaoewquEllai:Kqpaznqinsga
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`44/0 HOV
`
`Tardive Dyskinesia Titration Pack
`Week 1 and Week 2
`
`Austedo
`(d
`tetrabenazine) tablets
`
`6 mg and 9 mg
`
`SAMPLE-NOTFORSALE
`
`Press& hold
`
`button
`
`Pulloutcard
`
`Medlcatlon Guide Required: Each time AUSTEDO is
`dispensed. give the patient the accompanying Medication Guide.
`
`1 tablet dispenser containing 28 tablets in the following order:
`0 Week 1:14 purple tablets containing 6 mg deutetrabenazine
`0 Week 2: 14 blue tablets containing 9 mg deutetrabenazine
`
`NO ART WORK
`
`NO ART WORK
`Extended Label Area
`
`Z>199MPUBI>199M
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`6
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`
`Usual Dosage: See full Prescribing Information.
`Swallow tablet whole. do not chew. crush. or break.
`
`NDC 68546-1 79-1 4
`
`£3
`a:
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`9
`“7/110 “0"
`
`Tardive Dyskinesia Titration Pack
`Week 3
`
`
`
`
`
`
`
`Store at 25’ C (77‘ F); excursions permitted to 15°—30' C (59-86“ F).
`Protect from light and moisture.
`Keep out of reach of children.
`
`
`
`
`
`0303/11:7‘9879010[W"UeddfiJBd
`
`'OU|'VSfls1eognaoeuueqdEllai:Kqpaznqgnsga
`
`NO ART WORK
`
`N0 ART WORK
`
`N0 ART WORK
`
`N0 ART WORK
`
`Extended Label Area
`
`Press&hold 0Pull uutcard
`
`Medlcatlon Guide Required: Each time AUSTEDO is
`dispensed, give the patient the accompanying Medication Guide.
`
`1 tablet dispenser containing 14 tablets:
`0 Week 3: l4 beige tablets containing 12 mg deutetrabenazine
`
`3
`
`6 85‘
`
`6-179-1‘
`
`6
`
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`
`NO ART WORK
`
`
`
`Day20—Day21
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`
`
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`
`
`
`
`Day15—Day16—Day17—Day18—Day19—
`
`
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`
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`
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`
`(0
`
`N
`
`Rev. "/2020
`
`Distributed by".
`Teva Pharmaceuticals USA. Inc
`Parsippany. NJ 07054
`
`Rev. "/2020
`
`Distributed by:
`Teva Pharmaceuticals USA. Inc
`Parsippany. NJ 07054
`
`Rev. "/2020
`
`Distributed by:
`Teva Pharmaceuticals USA, Inc.
`Parsippany. NJ 07054
`
`OQOQ
`OQOQ
`OQOQ
`OQOQ
`OQOQ
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`@090
`
`######### M M M/YYYY
`
`
`\
`
`
`
`######### M M M/YYYY
`
`FP'Q
`
`
`
`Usual Dosage: See full Prescribing Information.
`Swallow tablet whole. do not chew. crush. or break.
`
`NDC 68546-180-28
`
`
`
`‘OU|'VSfls1eogneoeuueqdBAai:Kqpaznqgnsga
`
`'
`
`
`
`
`
`Store at 25’ C (77° F); excursions permitted to 15°—30' C (59’»86’ F).
`Protect from Light and moisture.
`Keep out of reach of children.
`
`
`
`OZOZ/II7‘9879010[N'Kuedd!519d
`
`N0 ART WORK
`
`NO ART WORK
`
`NO ART WORK
`Extended Label Area
`
`685 66-180-28
`
`1
`
`NO ART WORK
`
`NO ART WORK
`
`'u
`
`u!
`
`'3
`g
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`44/0 HOV
`
`Tardive Dyskinesia Titration Pack
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`Austedo
`(d
`tetrabenazine) tablets
`
`6 mg and 9 mg
`
`Press& hold
`button
`
`Pulloutcard
`
`Medlcauon Guide Required: Each time AUSTEDO is
`dispensed, give the patient the accompanying Medication Guide.
`
`1 tablet dispenser containing 28 tablets in the following order:
`0 Week 4:14 purple tablets containing 6 mg deutetr‘abenazine
`and 14 blue tablets containing 9 mg deutetrabenazine
`
`
`
`Day22—Day23—Day24—Day25—Day26—Day27—Day28
`
`OO OO OO OO
`
`lalquuadfws tqqmauuwg
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`
`
`0000000
`0000000
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`Day22—Day23—Day24—Day25—Day26—Day27—Day28
`
`
`
`
`
`Day22—Day23—Day24—Day25—Day26—Day27—Day28
`
`Day22_Day23—Day24—Day25_Day26_Day27—Day28
`
`OO OO OO OO
`
`NO ART WORK
`
`NO ART WORK
`
`NO ART WORK
`
`(0
`
`0]
`
`Rev. "/2020
`
`Distributed by".
`Teva Phannaceuticals USA. Int.
`Parsippany. NJ 07054
`
`Rev. "/2020
`
`Distributed by.
`Teva Pharmaceuticals USA. Int;
`Parsippany. NJ 07054
`
`Rev. “/20le
`
`Distributed by:
`Teva Pharmaceuticals USA, Inc.
`Parsippany, NJ 07054
`
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`
`OOOO
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`
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`
`######### M M M/Y YYY
`
`\
`
`OOOO
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`
`
`
`K ######### MMM/YYYY
`
`FP
`
`
`
`David
`Lewis
`
`Digitally signed by David Lewis
`Date: 2/09/2021 09:17:52AM
`GUID: 508da72000029f287fa31e664741b577
`
`(
`
`
`
`
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