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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
April 1, 2014
Anthrax Date 
BioThrax (Anthrax Vaccine Adsorbed)
November 23, 2015
Chickenpox Date 
ProQuad (MMRV) (prescribing information starts on page 2) October 23, 2018
Varivax (refrigerated) (prescribing information starts on page 2)
 October 19, 2018
Varivax (frozen) (prescribing information starts on page 2)
 October 19, 2018
Cholera Date 
Vaxchora June 10, 2016
Haemophilus Influenzae type b (Hib) Date 
Hiberix
April 30, 2018  
Pentacel
September 27, 2016 
ActHIB May 25, 2016
Menhibrix November 27, 2013
PedvaxHIB April 27, 2011
Hepatitis A Date 
Twinrix
December 8, 2016 
Havrix
April 25, 2016
Vaqta February 1, 2014
Hepatitis B Date 
Heplisav-B March 22, 2018 
Twinrix
December 8, 2016 
Engerix-B April 28, 2016
Pediarix
April 25, 2016 
Recombivax HB November 1, 2014
Human Papillomavirus (HPV) Date 
Gardasil 9 (prescribing information starts on page 2) October 5, 2018
Influenza Seasonal Date 
Afluria (Quadrivalent) June 4, 2018
Fluad (Trivalent)  June 2018
Fluarix (Quadrivalent) June 2018
Flublok (Quadrivalent) June 2018
Flucelvax (Quadrivalent)
July 2018
Flulaval (Quadrivalent)
June 2018
FluMist (Quadrivalent) August 2018 
Fluzone (Quadrivalent)
June 2018
Fluzone High-Dose
June 2018
Japanese Encephalitis Date 
Ixiaro (prescribing information starts on page 2) October 4, 2018
Meningococcal Date 
Trumenba (B)
March 14, 2018 
Bexsero (B)
October 12, 2017 
Menveo (prescribing information starts on page 2)
 October 4, 2018
Menactra
April 26, 2018 
Menomune  April 6, 2016
Menhibrix
November 27, 2013
Measles-Mumps-Rubella Date 
M-M-R II
May 16, 2017 
ProQuad (MMRV) (prescribing information starts on page 2)
October 23, 2018
Pneumococcal Date 
Prevnar 13 August 22, 2017
Pneumovax 23 December 30, 2014
Polio Date 
Pentacel
September 27, 2016 
Kinrix April 25, 2016
Pediarix April 25, 2016
IPOL August 6, 2015
Quadracel March 24, 2015
Rabies Date 
RabAvert August 3, 2018
Imovax July 3, 2013
Rotavirus Date 
RotaTeq
February 23, 2017 
Rotarix April 25, 2016
Shingles Date 
Zostavax (refrigerated) April 19, 2018
Zostavax (frozen)
April 19, 2018 
Shingrix (prescribing information starts on page 2)
September 18, 2018
Smallpox Date 
ACAM2000 March 1, 2018
Vaccinia Immune Globulin January 1, 2010
Tetanus-Diphtheria-Pertussis Date 
Adacel
September 29, 2017
Pentacel
September 27, 2016 
Daptacel
September 16, 2016 
Infanrix
April 28, 2016 
Boostrix April 25, 2016
Kinrix April 25, 2016
Pediarix April 25, 2016
Quadracel March 24, 2015
Tenivac
 October 25, 2013
Diphtheria and Tetanus Toxoid Adsorbed June 1, 2013 
Tuberculosis Date 
Tubersol April 22, 2016
Aplisol February 19, 2014
Typhoid Date 
Typhim Vi March 27, 2014
Vivotif September 1, 2013
Yellow Fever Date 
YF-VAX June 15, 2016
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