125742 S2 M1 com25ctpus carton puurs

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

1

Document text

MUST BE DILUTED BEFORE USE with 
sterile 0.9% Sodium Chloride Injection, USP (supplied separately).
After dilution, store the vaccine at 
2°C to 25°C (35°F to 77°F). 
Discard after 6 hours.25 Multiple Dose Vials
(after dilution each vial contains 
6 doses of 0.3 mL)Suspension for Intramuscular Injection
Rx onlyNDC 0069-1000-03
STORAGE: Prior to dilution, store at -90°C to -60°C (-130°F to -76°F).Store in this carton to protect from light.
DOSAGE AND ADMINISTRATION:
After dilution, each vial contains6 doses of 0.3 mL.
Contains no preservative.
300691000038
See prescribing 
information or scan QR code.Manufactured for
BioNTechManufacturing GmbHAn der Goldgrube 1255131 Mainz, Germany
Manufactured by 
Pfizer Inc. New York, NY 10017
US License No. XXXX
25 Multiple Dose Vials
(after dilution each vial contains
6 doses of 0.3 mL)Suspension for Intramuscular Injection
COM25CTPUS
NOTE:
Area around QR Code is a requiredquiet zone.
Nothing is to print within this space.Code to scan as:
https://www.pfi.sr/comirnatyComirnaty 25ct Carton COM25CTPUS - Puurs        15P      April 23, 2021     am
Black      PMS 7671      PMS 2162      PMS 7597
Minimum point size - 7pt.
B O T CHP Z RB NT HP Z RB NT C P Z B ONT HP Z RB NT HP Z B O T CHP Z B ONT HP Z RB NT C P Z B O T CHP Z R ONT HP Z RFPO
FPO UPC-AComirnaty 25ct Carton COM25CTPUS - Puurs_15.pdf   1   4/23/21   1:24 PM
090177e196fd381d\Approved\Approved On: 10-May-2021 03:41 (GMT)
FDA-CBER-2021-5683-0225023