Vaccine Information: Janssen COVID-19 Vaccine (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 timeof 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
JANSSEN COVID-19 VACCINE ad26.cov2.s injection, suspension | ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
|
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: 05/2022 Janssen Products, LP
VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.
https://vxlabels.com/lib/vaccines/vax/janssen-covid-19-vaccine/page/5/