125742 S54 M1 carton com25ctpus 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.
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 Injection,
for Intramuscular Use
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:
Diluent (sterile 0.9% Sodium Chloride Injection, USP)supplied separately. Use the provided diluent or analternate brand of sterile 0.9% Sodium Chloride Injection, USP.
After dilution, each vial contains 6 doses of 0.3 mL.
Please see prescribing information for additional details including 
instructions for preparation, dosage and administration.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. 2229
25 Multiple Dose Vials
(after dilution each vial contains
6 doses of 0.3 mL)Suspension for Injection,
for Intramuscular Use
COM25CTPUS
®
®
NOTE:
Area around QR Code is a requiredquiet zone.
Nothing is to print within this space.Code to scan as:
https://www.comirnatyglobal.com
GTIN: 00 300691000038
LOT:
EXP:
NOTE - expiry format:
EXP: MM/YYYYComirnaty 25ct Carton COM25CTPUS - Puurs        20P      August 16, 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 RB 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_20.pdf   1   8/16/21   8:13 PM
090177e197d3482a\Approved\Approved On: 17-Aug-2021 04:35 (GMT)
FDA-CBER-2021-5683-0651808