Janssen COVID-19 Vaccine: Package Insert and Label Information (Page 5 of 5)
PRINCIPAL DISPLAY PANEL — 2.5 mL Vial Label
AW_177786
For use
under
Emergency
Use
Authorization
Janssen COVID-19
Vaccine
5 doses of 0.5 mL
Intramuscular Injection
No Preservative
For EXP: www.vaxcheck.jnj
After first use, hold at
2°C to 8°C (36°F to 46°F).
Discard after 6 hours.
Record date and time of first use:
LOT
PRINCIPAL DISPLAY PANEL — 10 Vial Carton
NDC 59676-580-15
No Preservative
10 Multi-dose Vials
Each vial contains 5 doses of 0.5 mL
Janssen COVID-19 Vaccine
SUSPENSION FOR INTRAMUSCULAR INJECTION
For use under Emergency Use Authorization
Attention: After first use, hold at 2°C to 8°C (36°F to 46°F)
for up to 6 hours or at room temperature (maximally
25°C/77°F) for up to 2 hours. Discard if not used within
these times. Do not freeze.
janssen
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Labeler — Janssen Products, LP (804684207) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Janssen | 415960780 | api manufacture (59676-580) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Jannsen Biologics B.V. | 409612918 | api manufacture (59676-580) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Grand River Aseptic Manufacturing, Inc. | 005593490 | manufacture (59676-580) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Emergent Manufacturing Operations Baltimore LLC | 968316831 | manufacture (59676-580), analysis (59676-580) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Packaging Coordinators, LLC | 078525133 | pack (59676-580), label (59676-580) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Catalent Indiana, LLC | 172209277 | manufacture (59676-580), pack (59676-580), analysis (59676-580) |
Revised: 03/2023 Janssen Products, LP
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