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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 (prescribing information starts on page 2)
October 15, 2019
Anthrax Date
BioThrax (Anthrax Vaccine Adsorbed)
November 23, 2015
Chickenpox Date
ProQuad (MMRV) (prescribing information starts on page 2)
September 15, 2020
Varivax (refrigerated) (prescribing information starts on page 2)
September 15, 2020
Varivax (frozen) (prescribing information starts on page 2)
September 15, 2020
Cholera Date
Vaxchora (prescribing information starts on page 2)
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 (prescribing information starts on page 2)
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 (prescribing information starts on page 2)
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)
August 27, 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) (prescribing information starts on page 2)
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
June 19, 2020
ProQuad (MMRV) (prescribing information starts on page 2)
September 15, 2020
Pneumococcal Date
Pneumovax 23
November 26, 2019
Prevnar 13
August 22, 2017
Polio Date
IPOL
August 6, 2015
Kinrix (prescribing information starts on page 2)
November 6, 2019
Pediarix (prescribing information starts on page 2)
November 6, 2019
Pentacel (prescribing information starts on page 2)
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 (prescribing information starts on page 2)
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 (prescribing information starts on page 2)
September 10, 2020
Daptacel (prescribing information starts on page 2)
September 16, 2016
Diphtheria and Tetanus Toxoid Adsorbed (prescribing information starts on page 2)
December 20, 2018
Infanrix (prescribing information starts on page 2)
November 6, 2019
Kinrix (prescribing information starts on page 2)
November 6, 2019
Pediarix (prescribing information starts on page 2)
November 6, 2019
Pentacel (prescribing information starts on page 2)
June 11, 2019
Quadracel (prescribing information starts on page 2)
June 11, 2019
Tenivac (prescribing information starts on page 2)
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 (prescribing information starts on page 2)
March 20, 2020
Vivotif
September 1, 2013
Yellow Fever Date
YF-VAX
August 6, 2019

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