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Package Inserts

The Food & Drug Administration's Center for Biologics Evaluation and Research (CBER) regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products. It also approves the product labeling (package insert).

Please click below for the latest package inserts for licensed vaccines:

Adenovirus Date 
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
October 15, 2019
Anthrax Date 
BioThrax (Anthrax Vaccine Adsorbed)
November 23, 2015
Chickenpox Date 
ProQuad (MMRV) (prescribing information starts on page 2) January 22, 2019
Varivax (refrigerated) (prescribing information starts on page 2)
January 23, 2019
Varivax (frozen)
January 23, 2019
Cholera Date 
Vaxchora February 13, 2020
Haemophilus Influenzae type b (Hib) Date 
ActHIB (prescribing information starts on page 2) May 24, 2019
Hiberix
April 30, 2018
PedvaxHIB
April 27, 2011
Pentacel
June 11, 2019
Vaxelis (prescribing information starts on page 2) May 5, 2020
Hepatitis A Date 
Havrix (prescribing information starts on page 2)
December 19, 2018
Twinrix (prescribing information starts on page 2)
December 18, 2018
Vaqta (prescribing information starts on page 2) December 20, 2018
Hepatitis B Date 
Engerix-B
December 19, 2018
Heplisav-B (prescribing information starts on page 2) May 6, 2020 
Pediarix
November 6, 2019 
Recombivax HB
December 21, 2018
Twinrix (prescribing information starts on page 2)
December 18, 2018
Vaxelis (prescribing information starts on page 2)
May 5, 2020
Human Papillomavirus (HPV) Date 
Gardasil 9 (prescribing information starts on page 2) June 12, 2020
Influenza, Northern Hemisphere Date 
DoD-contracted
Afluria (Quadrivalent) (prescribing information starts on page 2)
July 2, 2020
Flucelvax (Quadrivalent) (prescribing information starts on page 2)
July 2, 2020
Fluad (Quadrivalent) July 2, 2020
Not DoD-contracted
Fluarix (Quadrivalent) (prescribing information starts on page 2)
July 2, 2020
Flublok (Quadrivalent) (prescribing information starts on page 2)
July 2, 2020
FluLaval (Quadrivalent) (prescribing information starts on page 2)
July 2, 2020
FluMist Intranasal (Quadrivalent) (prescribing information starts on page 2)
July 9, 2020
Fluzone (Quadrivalent) (prescribing information starts on page 2)
July 2, 2020
Fluzone High-Dose (Quadrivalent) (prescribing information starts on page 2)
July 2, 2020
Influenza, Southern Hemisphere Date 
Fluzone (Quadrivalent) Southern Hemisphere September 2019
Japanese Encephalitis Date 
Ixiaro (prescribing information starts on page 2) October 4, 2018
Meningococcal Date 
Bexsero (B)
October 24, 2019
Trumenba (B)
March 14, 2018 
Menactra
April 27, 2018 
Menveo (prescribing information starts on page 2)
July 28, 2020
Measles-Mumps-Rubella Date 
M-M-R II
May 16, 2017 
ProQuad (MMRV) (prescribing information starts on page 2)
January 22, 2019
Pneumococcal Date 
Pneumovax 23
November 26, 2019
Prevnar 13 August 22, 2017
Polio Date 
IPOL
August 6, 2015
Kinrix
November 6, 2019
Pediarix
November 6, 2019
Pentacel
June 11, 2019 
Quadracel (prescribing information starts on page 2)
June 11, 2019
Vaxelis (prescribing information starts on page 2)
May 5, 2020
Rabies Date 
Imovax October 25, 2019
RabAvert August 3, 2018
Rotavirus Date 
Rotarix
November 12, 2019
RotaTeq
February 23, 2017 
Shingles Date 
Shingrix (prescribing information starts on page 2)
May 17, 2019
Zostavax (refrigerated) (prescribing information starts on page 2) February 21, 2019
Zostavax (frozen) (prescribing information starts on page 2)
February 21, 2019
Smallpox Date 
ACAM2000 March 1, 2018
JYNNEOS September 24, 2019 
Vaccinia Immune Globulin January 1, 2010
Tetanus-Diphtheria-Pertussis Date 
Adacel (prescribing information starts on page 2)
January 11, 2019
Boostrix
April 25, 2019
Daptacel
September 16, 2016
Diphtheria and Tetanus Toxoid Adsorbed (prescribing information starts on page 2)
December 20, 2018
Infanrix
November 6, 2019
Kinrix November 6, 2019
Pediarix November 6, 2019
Pentacel
June 11, 2019
Quadracel (prescribing information starts on page 2) June 11, 2019
Tenivac
December 6, 2019
Vaxelis (prescribing information starts on page 2)
May 5, 2020
Tuberculosis Date 
Aplisol
February 19, 2014 
Tubersol April 22, 2016
Typhoid Date 
Typhim Vi March 20, 2020
Vivotif September 1, 2013
Yellow Fever Date 
YF-VAX August 6, 2019
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