FDA Label for Pfizer-biontech Covid-19 Vaccine
View Indications, Usage & Precautions
Pfizer-biontech Covid-19 Vaccine Product Label
The following document was submitted to the FDA by the labeler of this product Pfizer Manufacturing Belgium Nv. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Principal Display Panel – 3 Doses Of 0.3 Ml Multiple Dose Vial Label
Pfizer-BioNTech COVID-19 Vaccine
2023 – 2024 Formula
DILUTE PRIOR TO USE
Age 6m to < 5y
After dilution – 3 doses of 0.3 mL
For intramuscular use. Contains no preservative.
For use under Emergency Use Authorization.
After dilution store at 2 to 25°C (35 to 77°F) and
discard after 12 hours.
Dilution date and time:
NDC 59267-4315-1
Principal Display Panel – 10 Multiple Dose Vial Carton
NDC 59267-4315-2
Pfizer-BioNTech
COVID-19 Vaccine
2023 – 2024 Formula
Suspension for Intramuscular Injection
DILUTE PRIOR TO USE
10 Multiple Dose Vials
After dilution each vial contains 3 doses of 0.3 mL
For age 6 months to < 5 years
For use under Emergency Use Authorization.
BIONTECH
Pfizer
Rx only
Principal Display Panel – 0.3 Ml Single Dose Vial Label
Pfizer-BioNTech COVID-19 Vaccine
2023 – 2024 Formula
DO NOT DILUTE
Age 5y to < 12y
Vial contains 1 dose of 0.3 mL
For intramuscular use.
For use under Emergency Use Authorization.
NDC 59267-4331-1
Principal Display Panel – 10 Single Dose Vial Carton
NDC 59267-4331-2
Pfizer-BioNTech
COVID-19 Vaccine
2023 – 2024 Formula
Suspension for Intramuscular Injection
DO NOT DILUTE
10 Single Dose Vials
Each vial contains 1 dose of 0.3 mL
For age 5 years to < 12 years
For use under Emergency Use Authorization.
BIONTECH
Pfizer
Rx only
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