FDA Label for Antigen Component
View Indications, Usage & Precautions
Antigen Component Product Label
The following document was submitted to the FDA by the labeler of this product Sanofi Pasteur Inc.. 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.
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Principal Display Panel - 10 Dose Vial Label
NDC 49281-618-78
Vial 1 of 2
ANTIGEN COMPONENT
for Sanofi Pasteur COVID-19 Vaccine, Adjuvanted
After mixing, emulsion for intramuscular injection
For use under Emergency Use Authorization.
NOT TO BE USED ALONE.
Add 1 vial of AS03 Adjuvant Component to form the Vaccine.
Multiple Dose Vial (after mixing, contains 10 doses of 0.5 mL). After
mixing, hold at 23°C to 27°C (73°F to 80°F). Discard after 6 hours.
Refer to FDA-authorized Fact Sheet for mixing instructions.
No Preservative
Record date and time of mixing:
Manufactured by: Sanofi Pasteur Inc.
Principal Display Panel - 10 Vial Carton
NDC 49281-618-20
ANTIGEN COMPONENT
for Sanofi Pasteur COVID-19 Vaccine, Adjuvanted
After mixing, emulsion for intramuscular injection
For use under Emergency Use Authorization
CONTENTS: 10 Multiple Dose Vials (after mixing with AS03 Adjuvant Component,
each vial contains ten 0.5 mL doses of Vaccine)
NOTICE: NOT TO BE USED ALONE
One vial of AS03 Adjuvant Component MUST BE ADDED to one vial of
Antigen Component to form the Vaccine.
794426
SANOFI PASTEUR
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