rozerem™ 8 mg sample carton · draft copy die line final proof date: 7/28/2005 new proof required...
TRANSCRIPT
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
FINAL PROOF Date: 7/28/2005
New Proof Required OK With Changes
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
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
DIE LINE VARNISH BLACK
FINAL PROOF Date: 7/28/2005
Affix Approval Label Here
New Proof Required OK With Changes
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
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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
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
DIE LINE VARNISH BLACK
FINAL PROOF Date: 7/28/2005
Affix Approval Label Here
New Proof Required OK With Changes
Rozerem™ 8 mg/100 Count
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
(ramelteon tablets)8 mg
100 Tablets
07-1115
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FFPP
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Rx Only
N 36
47
64
-80
5-1
0
4
PMS 185C PMS 130C PMS 3435C
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
DIE LINE VARNISH BLACK
INTERNAL DRAFT PROOF SUBMISSION No.: 1 Date: 4/92/2004
Affix Approval Label Here
New Proof Required OK With Changes
Rozerem™ 8 mg/500 Count
Item No.: 07-1118 P/N.:
FINAL PROOF Date: 7/28/2005
New Proof Required OK With Changes
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
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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
PMS 185C PMS 3435C PMS 130C
NDC 64764-805-50
RozeremTM
(ramelteon tablets)8 mg
500 Tablets
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
Sam
ple
DIE LINE VARNISH BLACK
FINAL PROOF Date: 7/28/2005
Affix Approval Label Here
New Proof Required OK With Changes
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
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amr
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FFPP
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N 36
47
64
-80
5-3
3
3
PMS 185C PMS 3435C PMS 130C
NDC 64764-805-33
RozeremTM
(ramelteon tablets)8 mg
30 TabletsProfessional Sample - Not for Sale
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