Vaccine Information: FluMist Quadrivalent (Page 5 of 5)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

2019-2020 Formula

Influenza Vaccine Live, Intranasal
FluMist® Quadrivalent


STORE REFRIGERATED
at 2º-8ºC (35º-46ºF)

Rx only

For 2-49 years of age

PROTECT FROM LIGHT

FOR INTRANASAL

ADMINISTRATION ONLY
Contents: 10 pre-filled sprayers
One 0.2 mL dose each
(0.1 mL per nostril)

Manufactured by MedImmune, LLC.

One MedImmune Way

Gaithersburbg, MD 20878 USA

U.S. Govt. License No. 1799

Product of the United Kingdom

MedImmune

FluMist carton
(click image for full-size original)
FLUMIST QUADRIVALENT influenza vaccine live intranasal spray
Product Information
Product Type VACCINE Item Code (Source) NDC:66019-306
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INFLUENZA A VIRUS A/SWITZERLAND/3330/2017 (H1N1) LIVE (ATTENUATED) ANTIGEN (INFLUENZA A VIRUS) INFLUENZA A VIRUS A/SWITZERLAND/3330/2017 (H1N1) LIVE (ATTENUATED) ANTIGEN 10000000 [FFU] in 0.2 mL
INFLUENZA A VIRUS A/KANSAS/14/2017 (H3N2) LIVE (ATTENUATED) ANTIGEN (INFLUENZA A VIRUS) INFLUENZA A VIRUS A/KANSAS/14/2017 (H3N2) LIVE (ATTENUATED) ANTIGEN 10000000 [FFU] in 0.2 mL
INFLUENZA B VIRUS B/PHUKET/3073/2013 LIVE (ATTENUATED) ANTIGEN (INFLUENZA B VIRUS B/PHUKET/3073/2013 LIVE (ATTENUATED) ANTIGEN) INFLUENZA B VIRUS B/PHUKET/3073/2013 LIVE (ATTENUATED) ANTIGEN 10000000 [FFU] in 0.2 mL
INFLUENZA B VIRUS B/COLORADO/06/2017 LIVE (ATTENUATED) ANTIGEN (INFLUENZA B VIRUS B/COLORADO/06/2017 LIVE (ATTENUATED) ANTIGEN) INFLUENZA B VIRUS B/COLORADO/06/2017 LIVE (ATTENUATED) ANTIGEN 10000000 [FFU] in 0.2 mL
Inactive Ingredients
Ingredient Name Strength
MONOSODIUM GLUTAMATE 0.188 mg in 0.2 mL
GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) 2.00 mg in 0.2 mL
ARGININE 2.42 mg in 0.2 mL
SUCROSE 13.68 mg in 0.2 mL
DIBASIC POTASSIUM PHOSPHATE 2.26 mg in 0.2 mL
POTASSIUM PHOSPHATE, MONOBASIC 0.96 mg in 0.2 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66019-306-10 10 APPLICATOR in 1 PACKAGE contains a APPLICATOR (66019-306-01)
1 NDC:66019-306-01 0.2 mL in 1 APPLICATOR This package is contained within the PACKAGE (66019-306-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125020 09/05/2019
Labeler — MedImmune, LLC (489176682)
Registrant — Medimmune, LLC (190639906)

Revised: 09/2019 MedImmune, LLC

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