Back to Top Skip to main content

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)
 October 19, 2018
Cholera Date 
Vaxchora June 10, 2016
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
September 27, 2016
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 March 22, 2018 
Pediarix
April 25, 2016 
Recombivax HB
December 21, 2018
Twinrix (prescribing information starts on page 2)
December 18, 2018
Human Papillomavirus (HPV) Date 
Gardasil 9 (prescribing information starts on page 2) October 5, 2018
Influenza Seasonal Date 
Afluria (Quadrivalent) (prescribing information starts on page 2) July 2, 2019
Fluad (Trivalent) July 2, 2019
Fluarix (Quadrivalent) July 2, 2019
Flublok (Quadrivalent) (prescribing information starts on page 2) July 2, 2019
Flucelvax (Quadrivalent)
July 2, 2019
Flulaval (Quadrivalent) (prescribing information starts on page 2)
July 2, 2019
FluMist (Quadrivalent) (prescribing information starts on page 2) July 15, 2019
Fluzone (Quadrivalent) (prescribing information starts on page 2)
July 2, 2019
Fluzone High-Dose
Coming soon
Japanese Encephalitis Date 
Ixiaro (prescribing information starts on page 2) October 4, 2018
Meningococcal Date 
Bexsero (B)
May 31, 2018
Trumenba (B)
March 14, 2018 
Menactra
April 27, 2018 
Menveo (prescribing information starts on page 2)
October 4, 2018
Measles-Mumps-Rubella Date 
M-M-R II
May 16, 2017 
ProQuad (MMRV) (prescribing information starts on page 2)
October 23, 2018
Pneumococcal Date 
Pneumovax 23
December 30, 2014
Prevnar 13 August 22, 2017
Polio Date 
IPOL
August 6, 2015
Kinrix
April 25, 2016
Pediarix
April 25, 2016
Pentacel
September 27, 2016 
Quadracel (prescribing information starts on page 2) June 11, 2019
Rabies Date 
Imovax July 3, 2013
RabAvert August 3, 2018
Rotavirus Date 
Rotarix
April 25, 2016
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
Vaccinia Immune Globulin January 1, 2010
Tetanus-Diphtheria-Pertussis Date 
Adacel (prescribing information starts on page 2)
September 29, 2017
Boostrix
April 25, 2019
Daptacel
September 16, 2016
Diphtheria and Tetanus Toxoid Adsorbed (prescribing information starts on page 2)
December 20, 2018
Infanrix
April 28, 2016 
Kinrix April 25, 2016
Pediarix April 25, 2016
Pentacel
September 27, 2016
Quadracel (prescribing information starts on page 2) June 11, 2019
Tenivac
 October 25, 2013
Tuberculosis Date 
Aplisol
February 19, 2014 
Tubersol April 22, 2016
Typhoid Date 
Typhim Vi March 27, 2014
Vivotif September 1, 2013
Yellow Fever Date 
YF-VAX June 15, 2016
COMING SOON

DHA Address: 7700 Arlington Boulevard | Suite 5101 | Falls Church, VA | 22042-5101

Some documents are presented in Portable Document Format (PDF). A PDF reader is required for viewing: Download a PDF Reader or learn more about PDFs.