125742 S2 M1 com25ctkz carton kzoo

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.NDC 0069-1000-03
25 Multiple Dose Vials
(after dilution each vial contains 6 doses of 0.3 mL)Suspension for Intramuscular Injection
See prescribing information
or scan QR code.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 contains 6 doses of 0.3 mL.
Contains no preservative.
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 only300691000038Manufactured for
BioNTechManufacturing GmbHAn der Goldgrube 1255131 Mainz, Germany
Manufactured by
Pfizer Inc.New York, NY 10017
US License No. XXXXCOM25CTKZ
LOT/EXP:
FPO 128 10 mil
PAAXXXXXX
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 - Kzoo COM25CTKZ        16P    April 23, 2021     am
Black      PMS 7671      PMS 2162      PMS 7597
Minimum point size - 7pt.
FPOFPO UPC-A
B NT C P Z B ONT HP Z RB O T CHP Z RB NT C P Z B ONT HP Z RB O T CHP Z RB NT C P Z B ONT HP Z RB O T CHP Z RB NT C P Z B ONT HP Z R
090177e196fd281e\Approved\Approved On: 10-May-2021 03:36 (GMT)
FDA-CBER-2021-5683-0225022