Download - Rozerem™ 8 mg Sample Carton · DRAFT COPY DIE LINE FINAL PROOF Date: 7/28/2005 New Proof Required OK With Changes Rozerem™8 mg Sample Carton Item No.:09-1114 P/N.: Size:2.00"X

DRAFT COPY DIE LINE

FINAL PROOF Date: 7/28/2005

New Proof Required OK With Changes

Rozerem™ 8 mg Sample Carton

Item No.: 09-1114 P/N.:

Size: 2.00" X .703" X 3.4375"

Rozerem™ 8 mg Sample Carton

VARNISH PMS 185C PMS 3435C PMS 130C

(50.8 mm X 17.86 mm X 87.31 mm)

Roz

erem

TM

(ram

elte

on ta

blet

s)

8 m

g

09-1

114

FP

O

09-1

114

FP

O

Lot:

Exp.:

(ramelteon tablets) 8 mg

RozeremTM

For complete prescribing information,please visit www.rozerem.com.

Store at 25ºC (77ºF); excursions15º–30ºC (59º–86ºF).

Protect from moisture and humidity.

Keep out of reach of children.

Each film-coated tablet contains 8 mg of ramelteon.

See bottom panel for lot number and expiration date.

© 2005 Takeda Pharmaceuticals America, Inc.08/05 Printed in U.S.A. 09-1114

Rozerem™ is a trademark ofTakeda Pharmaceutical Company Limitedand used under license byTakeda Pharmaceuticals America, Inc.

Professional Sample—Not for SaleNDC 64764-805-37

Contains 1 patient sample of 3 tablets

Rx Only

(ramelteon tablets)

8 mg

RozeremTM

09-1114

FPO

09-1114

FPO

Drug Substance: Product of Japan

Drug Product manufactured byTakeda Pharmaceutical Company Limitedin Kilruddery, Co. Wicklow, Ireland

Marketed by:Takeda Pharmaceuticals America, Inc.Lincolnshire, IL 60069

See package insert for complete prescribing information.Store at 25ºC (77ºF); excursions 15º–30ºC (59º–86ºF).Protect from moisture and humidity.Keep out of reach of children.Each film-coated tablet contains 8 mg of ramelteon.

RozeremTM is a trademark ofTakeda Pharmaceutical Company Limitedand used under license byTakeda Pharmaceuticals America, Inc.

©2005 Takeda Pharmaceuticals America, Inc.08/05 Printed in U.S.A. 12-1117

(ramelteon tablets)RozeremTM

Rx Only



No.: 12-1117 P/N.:

Size: 4.875" x 3.5625" x 2.09375"(123.83 mm x 90.49 mm x 53.18 mm)

DRAFT COPY DIE LINE VARNISH PMS 185C PMS 3435C

See package insert for complete prescribing information.Store at 25ºC (77ºF); excursions 15º–30ºC (59º–86ºF).Protect from moisture and humidity.Keep out of reach of children.Each film-coated tablet contains 8 mg of ramelteon.

Rozerem™ 8 mg Sample Tray

Contains 6 patient sample units of 3 tablets eachProfessional Sample—Not for Sale

8 mg

Contains 6 patient sample units of 3 tablets eachNDC 64764-805-37

8 mg

(ramelteon tablets)Rozerem

TM

Contains 6 patient sample units of 3 tablets eachNDC 64764-805-37

8 mg

PMS 130C

12-1

117

Lot:

Exp.:

(ramelteon tablets)RozeremTM




DIE LINE VARNISH BLACK


Affix Approval Label Here


Rozerem™ 8 mg/30 Count

Item No.: 07-1112 P/N.:

Size: 3.50" x 1.625" (88.9 mm x 41.275 mm)

Rozerem ™ 8 mg/30 Count Label

Do not accept if seal imprintedwith “SEALED for YOURPROTECTION” over bottle opening is broken or missing.Each film-coated tablet contains 8 mg of ramelteon.Dispense in a USP tight,light-resistant container.See package insert forcomplete prescribing information.Keep out of reach of children.™ - Trademark

Lot:

Exp.:

Rx Only07-1112

.)F°68-°95( C °03 -° 51 s

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N 36

47

64

-80

5-3

0

2

PMS 185C PMS 3435C PMS 130C

NDC 64764-805-30

RozeremTM

(ramelteon tablets)8 mg

30 Tablets






Item No.: 07-1115 P/N.:

Size: 3.50" x 1.625" (88.9 mm x 41.275 mm)

Rozerem™ 8 mg/100 Count Label

Do not accept if seal imprintedwith ”SEALED for YOURPROTECTION” over bottle opening is broken or missing.Each film-coated tablet contains 8 mg of ramelteon.Dispense in a USP tight,light-resistant container.See package insert forcomplete prescribing information.Keep out of reach of children.™ - Trademark

NDC 64764-805-10

Lot:

Exp.:

RozeremTM


100 Tablets

07-1115

.)F°68-°95( C°03- °51 s

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Rx Only

N 36

47

64

-80

5-1

0

4






INTERNAL DRAFT PROOF SUBMISSION No.: 1 Date: 4/92/2004




Item No.: 07-1118 P/N.:



Rozerem™ 8 mg/500 Count Label

Do not accept if seal imprintedwith ”SEALED for YOURPROTECTION” over bottle opening is broken or missing.Each film-coated tablet contains 8 mg of ramelteon.Dispense in a USP tight,light-resistant container.See package insert forcomplete prescribing information.Keep out of reach of children.™ - Trademark

07-1118

.)F°68-°95( C°03 -°5 1 s

no isr

ucx e; )F°77(

C °52 ta

ero tS

.yt idi

mu

h d

na

eru tsi

om

mo rf t

ce t

orP K.

des

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hgit r

eni

a tn

oc

pe

e ©.

cnI,

acir

em

A slacituec

am r

ahP a

dekaT 50 02

FFPP

OO

Lot:

Exp.:

Size: 4.00" x 1.75" (101.6 mm x 44.45 mm)

N 36

47

64

-80

5-5

0

0

Rx Only


NDC 64764-805-50

RozeremTM


500 Tablets




Sam

ple





Rozerem™ 8 mg/30 Count Sample Label

Item No.: 07-1148 P/N.:

Size: 3.50" x 1.625" (88.9 mm x 41.275 mm)

Rozerem™ 8 mg/30 Count Sample Label

Do not accept if seal imprintedwith “SEALED for YOURPROTECTION” over bottle opening is broken or missing.Each film-coated tablet contains 8 mg of ramelteon.

K

See package insert forcomplete prescribing information.eep out of reach of children.

™ - Trademark

Lot:

Exp.:

Rx Only07-1148

.)F°68-°95( C °03 -° 51 s

noi sr

ucxe;)F °77(

C° 52 ta

erotS

.ytidi

muh

dn

a er

utsio

m m

orf tc

e torP K

.d

esolc ylt

hgit r

eni

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cnI,

ac ir

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A s la

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ekaT 5 002

FFPP

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N 36

47

64

-80

5-3

3

3


NDC 64764-805-33

RozeremTM


30 TabletsProfessional Sample - Not for Sale


