Emsam, Page 7
Emsam (selegiline transdermal system) is a transdermally administered antidepressant. When applied to intact skin, Emsam is designed to continuously deliver selegiline over a 24-hour period. Emsam is indicated for the treatment of major depressive disorder.
- 2
Adapted from K.I. Shulman, S.E. Walker, Psychiatric Annals 2001; 31:378-384
PRINCIPAL DISPLAY PANEL — 6 mg/24 h
NDC-49502-900-30
EACH UNIT DOSE PACKAGE IS NOT CHILD RESISTANT
Rx only
EMSAM®
(selegiline transdermal system)
6 mg/24 h
FOR TRANSDERMAL USE ONLY
Patient: Read enclosed Medication Guide.
Pharmacist: Dispense with enclosed
Medication Guide.
30 TRANSDERMAL
SYSTEMS
INSTRUCTIONS FOR APPLICATION
- Select and prepare an appropriate site on the (A) upper chest or back (below the neck and above the waist), (B) upper thigh, or (C) outer surface of the upper arm, as directed in the enclosed Medication Guide.
- Bend both sides of the clear peelable liner. Peel off one strip only of the clear liner. Avoid touching the sticky side of the transdermal system.
- Apply sticky side of the transdermal system to the chosen skin site. Remove remaining strip, gently roll remaining part onto skin, and press transdermal system firmly in place with the tips of your fingers.
For more detailed instructions, read enclosed Medication Guide.
Dosage: Apply one (1) transdermal system every 24 hours. Read enclosed Medication Guide.
Each transdermal system has a release rate of 6 mg selegiline per 24 hour period. Wear only one transdermal system at a time.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Distributed by
Dey Pharma, L.P.
Napa, CA 94558
Manufactured for
Somerset
Pharmaceuticals, Inc.
Morgantown, WV 26505
Rx only
PRINCIPAL DISPLAY PANEL — 9 mg/24 h
NDC-49502-901-30
EACH UNIT DOSE PACKAGE IS NOT CHILD RESISTANT
Rx only
EMSAM®
(selegiline transdermal system)
9 mg/24 h
Important: Do not eat certain foods.
Read enclosed Medication Guide.
FOR TRANSDERMAL USE ONLY
Pharmacist: Dispense with enclosed
Medication Guide.
30 TRANSDERMAL
SYSTEMS
INSTRUCTIONS FOR APPLICATION
- Select and prepare an appropriate site on the (A) upper chest or back (below the neck and above the waist), (B) upper thigh, or (C) outer surface of the upper arm, as directed in the enclosed Medication Guide.
- Bend both sides of the clear peelable liner. Peel off one strip only of the clear liner. Avoid touching the sticky side of the transdermal system.
- Apply sticky side of the transdermal system to the chosen skin site. Remove remaining strip, gently roll remaining part onto skin, and press transdermal system firmly in place with the tips of your fingers.
For more detailed instructions, read enclosed Medication Guide.
Dosage: Apply one (1) transdermal system every 24 hours. Read enclosed Medication Guide.
Each transdermal system has a release rate of 9 mg selegiline per 24 hour period. Wear only one transdermal system at a time.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Distributed by
Dey Pharma, L.P.
Napa, CA 94558
Manufactured for
Somerset
Pharmaceuticals, Inc.
Morgantown, WV 26505
Rx only
PRINCIPAL DISPLAY PANEL — 12 mg/24 h
NDC-49502-902-30
EACH UNIT DOSE PACKAGE IS NOT CHILD RESISTANT
Rx only
EMSAM®
(selegiline transdermal system)
12 mg/24 h
Important: Do not eat certain foods.
Read enclosed Medication Guide.
FOR TRANSDERMAL USE ONLY
Pharmacist: Dispense with enclosed
Medication Guide.
30 TRANSDERMAL
SYSTEMS
INSTRUCTIONS FOR APPLICATION
- Select and prepare an appropriate site on the (A) upper chest or back (below the neck and above the waist), (B) upper thigh, or (C) outer surface of the upper arm, as directed in the enclosed Medication Guide.
- Bend both sides of the clear peelable liner. Peel off one strip only of the clear liner. Avoid touching the sticky side of the transdermal system.
- Apply sticky side of the transdermal system to the chosen skin site. Remove remaining strip, gently roll remaining part onto skin, and press transdermal system firmly in place with the tips of your fingers.
For more detailed instructions, read enclosed Medication Guide.
Dosage: Apply one (1) transdermal system every 24 hours. Read enclosed Medication Guide.
Each transdermal system has a release rate of 12 mg selegiline per 24 hour period. Wear only one transdermal system at a time.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Distributed by
Dey Pharma, L.P.
Napa, CA 94558
Manufactured for
Somerset
Pharmaceuticals, Inc.
Morgantown, WV 26505
Rx only
| EMSAM selegiline patch | |||||||||||||||||||||||||||||||||
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| EMSAM selegiline patch | |||||||||||||||||||||
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| EMSAM selegiline patch | |||||||||||||||||||||
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| Labeler — Dey Pharma, L.P. (194775557) |
| Registrant — Somerset Pharmaceuticals, Inc (154311393) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Mylan Technologies Inc. | 063790265 | MANUFACTURE, ANALYSIS | |
Revised: 01/2010 Dey Pharma, L.P.





