HOME
ABOUT IAC
CONTACT
A-Z INDEX
DONATE
SHOP
SUBSCRIBE
Immunization Action Coalition

Food and Drug Administration

Package Inserts & FDA Product Approvals

Adenovirus Hib Meningococcal B Smallpox and Monkeypox
Anthrax Hepatitis A Mumps Td
BCG Hepatitis B Pneumococcal - PCV Tdap
Cholera HPV Pneumococcal - PPSV Typhoid
Dengue Influenza Polio - IPV Varicella (chickenpox)
DT Japanese encephalitis Rabies Yellow fever
DTaP Measles Rotavirus Zoster (shingles)
Ebola virus Meningococcal ACWY Rubella  

Product Approval - Adenovirus

Adenovirus Package Insert
Barr Labs Inc.
Adenovirus Product Approval 
 
 
     

Product Approval - Anthrax

BioThrax Package Insert
Emergent BioSolutions
BioThrax Product Approval 
 
 
     

Product Approval - BCG Vaccine (tuberculosis)

BCG Package Insert
Organon Teknica (Merck)
BCG Product Approval 
   
     

Product Approval - Cholera

Back to top
Vaxchora Package Insert
Emergent BioSolutions
Vaxchora Product Approval 
   
     

Product Approval - Dengue

Back to top
Dengvaxia Package Insert
Sanofi Pasteur
Dengvaxia Product Approval 
   
     

Product Approval - DT

DT (generic) Package Insert
Sanofi Pasteur
DT (generic) Product Approval 
   
     

Product Approval - DTaP

Daptacel Package Insert
Sanofi Pasteur
Daptacel Product Approval 
 
Pentacel Package Insert
Sanofi Pasteur
Pentacel Product Approval 
     
Infanrix Package Insert
GlaxoSmithKline
Infanrix Product Approval 
 
Quadracel Package Insert
Sanofi Pasteur
Quadracel Product Approval 
     
Kinrix Package Insert
GlaxoSmithKline
Kinrix Product Approval 
 
Vaxelis Package Insert
Sanofi Pasteur
Vaxelis Product Approval 
     
Pediarix Package Insert
GlaxoSmithKline
Pediarix Product Approval 
   
     

Product Approval - Ebola virus disease (EVD)

Ervebo Package Insert
Merck & Co, Inc.
Ervebo Product Approval 
 
 
     

Product Approval - Haemophilus influenzae type b

Back to top
ActHIB Package Insert
Sanofi Pasteur
ActHIB Product Approval 
 
Pentacel Package Insert
Sanofi Pasteur
Pentacel Product Approval 
     
Hiberix Package Insert
GlaxoSmithKline
Hiberix Product Approval 
 
Vaxelis Package Insert
Sanofi Pasteur
Vaxelis Product Approval 
     
PedvaxHIB Package Insert
Merck & Co., Inc.
PedvaxHIB Product Approval 
   
     

Product Approval - Hepatitis A

Havrix Package Insert
GlaxoSmithKline
Havrix Product Approval 
 
Vaqta Package Insert
Merck & Co., Inc.
Vaqta Product Approval 
     
Twinrix Package Insert
GlaxoSmithKline
Twinrix Product Approval 
   
     

Product Approval - Hepatitis B

Back to top
Engerix-B Package Insert
GlaxoSmithKline
Engerix-B Product Approval 
 
Recombivax HB Package Insert
Merck & Co., Inc.
Recombivax HB Product Approval 
     
Heplisav-B Package Insert
Dynavax Technologies
Heplisav-B Product Approval 
 
Twinrix Package Insert
GlaxoSmithKline
Twinrix Product Approval 
     
Pediarix Package Insert
GlaxoSmithKline
Pediarix Product Approval 
 
Vaxelis Package Insert
Sanofi Pasteur
Vaxelis Product Approval 
     

Product Approval - Human papillomavirus (HPV)

Gardasil 9 Package Insert
Merck & Co., Inc.
Gardasil 9 Product Approval 
   
     

Product Approval - Influenza

Back to top
Afluria Quadrivalent Package Insert
Seqirus
Afluria Quadrivalent Product Approval (injectable) 
 
Flucelvax Quadrivalent Package Insert
Seqirus
Flucelvax Quadrivalent Product Approval (injectable) 
     
Fluad Package Insert
Seqirus
Fluad Product Approval (injectable) 
 
FluLaval Quadrivalent Package Insert
ID Biomedical Corporation
FluLaval Quadrivalent Product Approval (injectable) 
     
Fluad Quadrivalent Package Insert
Seqirus
Fluad Quadrivalent Product Approval (injectable) (available in 2020–21 season) 
 
FluMist Quadrivalent Package Insert
MedImmune, Inc.
FluMist Quadrivalent Product Approval (intranasal) 
     
Fluarix Quadrivalent Package Insert
GlaxoSmithKline
Fluarix Quadrivalent Product Approval (injectable) 
 
Fluzone High Dose Quadrivalent Package Insert
Sanofi Pasteur
Fluzone High Dose Quadrivalent Product Approval (injectable)
     
Flublok Quadrivalent Package Insert
Protein Sciences Corporation
Flublok Quadrivalent Product Approval (injectable) 
 
Fluzone Quadrivalent Package Insert
Sanofi Pasteur
Fluzone Quadrivalent Product Approval (injectable) 
     

Product Approval - Japanese encephalitis

IXIARO Package Insert
Valneva
IXIARO Product Approval 
 
 
 
 
     

Product Approval - Measles

MMR II Package Insert
Merck & Co., Inc.
MMR II Product Approval 
 
ProQuad Package Insert
Merck & Co., Inc.
ProQuad Product Approval 
     

Product Approval - Meningococcal ACWY

Back to top
Menactra Package Insert
Sanofi Pasteur
Menactra Product Approval 
 
Menveo Package Insert
Glaxo Smith Kline
Menveo Product Approval 
     
MenQuadfi Package Insert
Sanofi Pasteur
MenQuadfi Product Approval 
   
     

Product Approval - Meningococcal B

Back to top
Bexsero Package Insert
GlaxoSmithKline
Bexsero Product Approval 
 
Trumenba Package Insert
Pfizer
Trumenba Product Approval 
     

Product Approval - Mumps

Back to top
MMR II Package Insert
Merck & Co.
MMR II Product Approval 
 
ProQuad Package Insert
Merck & Co.
ProQuad Product Approval 
     

Product Approval - Pneumococcal (PCV)

Prevnar 13 Package Insert
Pfizer
Prevnar 13 Product Approval 
   
     

Product Approval - Pneumococcal (PPSV)

Pneumovax 23 Package Insert
Merck & Co., Inc.
Pneumovax 23 Product Approval 
   
     

Product Approval - Polio (IPV)

IPOL Package Insert
Sanofi Pasteur
IPOL Product Approval 
 
Pentacel Package Insert
Sanofi Pasteur
Pentacel Product Approval 
     
Kinrix Package Insert
GlaxoSmithKline
Kinrix Product Approval 
 
Quadracel Package Insert
Sanofi Pasteur
Quadracel Product Approval 
     
Pediarix Package Insert
GlaxoSmithKline
Pediarix Product Approval 
 
Vaxelis Package Insert
Sanofi Pasteur
Vaxelis Product Approval 
     

Product Approval - Rabies

Back to top
Imovax Package Insert
Sanofi Pasteur
Imovax Product Approval 
 
RabAvert Package Insert
Glaxo Smith Kline
RabAvert Product Approval 
     

Product Approval - Rotavirus

Rotarix Package Insert
GlaxoSmithKline
Rotarix Product Approval 
 
RotaTeq Package Insert
Merck & Co., Inc.
RotaTeq Product Approval 
     

Product Approval - Rubella

MMR II Package Insert
Merck & Co., Inc.
MMR II Product Approval 
 
ProQuad Package Insert
Merck & Co., Inc.
ProQuad Product Approval 
     

Product Approval - Smallpox and Monkeypox

ACAM2000 Package Insert - (smallpox only)
Emergent Biosolutions
ACAM2000 Product Approval - (smallpox only)
 
Jynneos Package Insert
Bavarian Nordic A/S
Jynneos Product Approval 
     

Product Approval - Tetanus (Td)

Back to top
Td (generic) Package Insert
Mass. Biological Lab
Td (generic) Product Approval 
 
Tenivac Package Insert
Sanofi Pasteur
Tenivac Product Approval 
     

Product Approval - Tetanus (Tdap)

Adacel Package Insert
Sanofi Pasteur
Adacel Product Approval 
 
Boostrix Package Insert
GlaxoSmithKline
Boostrix Product Approval 
     

Product Approval - Typhoid

Typhim Vi Package Insert
Sanofi Pasteur
Typhim Vi Product Approval 
 
Vivotif Package Insert
Emergent BioSoulutions
Vivotif Product Approval 
     

Product Approval - Varicella (chickenpox)

Varivax Package Insert
Merck & Co., Inc.
Varivax Product Approval 
 
ProQuad Package Insert
Merck & Co., Inc.
ProQuad Product Approval 
     

Product Approval - Yellow Fever

Back to top
YF-Vax Package Insert
Sanofi Pasteur
YF-Vax Product Approval 
   
     

Product Approval - Zoster (shingles)

Shingrix Package Insert
GlaxoSmithKline
Shingrix Product Approval 
   
   
This page was updated on November 20, 2020.
This page was reviewed on July 23, 2020.
 
- Guide to immunize.org -
A-Z INDEX
ABOUT IAC
IAC in the News
Staff
IAC History through Film
ACIP
RECOMMENDATIONS
ADOLESCENT VACCINATION
ADULT VACCINATION
ADULT VACCINATION GUIDE
ASK THE EXPERTS
Administering Vaccines
COVID-19 & Routine Vac
Hepatitis B
MMR
Storage and Handling
>> view all
BECKY PAYNE AWARD
BILLING & CODING
BIRTH DOSE GUIDEBOOK
CALENDAR OF EVENTS
CDC INFORMATION
CDC SCHEDULES
CLINIC TOOLS
Administering Vaccines
Adolescent Vaccination
Adult Vaccination
Screening for Contraindications
Vaccination and COVID-19
Vaccine Recommendations
Vaccine Storage & Handling
>> view all
COALITIONS FOR
IMMUNIZATION
CONTRIBUTE TO IAC
COVID-19 RELATED
Ask the Experts: COVID-19
   & Routine Vac
Clinic Tools: Vaccination and
   COVID-19
Repository of Resources
DEAR COLLEAGUE LETTERS
16-year-old Visit
HPV
MenACWY Dose #2
DONATE TO IAC
EDUCATIONAL MATERIALS
EMAIL NEWS SERVICES
E-NEWSLETTER: IAC EXPRESS
EXEMPTIONS
FAQs
FAVORITES
FDA PACKAGE INSERTS
FILMS ABOUT IAC
GIVE BIRTH TO THE
END OF HEP B
HANDOUTS FOR
PATIENTS & STAFF
View All Materials
Administering Vaccines
Adolescent Vaccination
Adult Vaccination
Contraindications / Precautions
Documenting Vaccination
Healthcare Personnel
Managing Vaccine Reactions
Parent Handouts
Pregnancy and Vaccines
Q&As: Diseases and Vaccines
Q&As: Easy-to-Read
Schedules for Patients
Screening Checklists
Standing Orders Templates
Storage & Handling
Strategies & Policies
Temperature Logs
Top Handouts
Vaccine Confidence
Vaccine Recommendations
>> view all
HEP B BIRTH DOSE
HONOR ROLLS
Hep B Birth Dose
Mandatory Flu Vaccination for HCP
MenB Vaccination for Colleges
IAC EXPRESS
Subscribe to IAC Express
IMAGE LIBRARY
LAWS AND MANDATES
MANUFACTURERS
MASS VACCINATION
RESOURCES
NATIONAL ADULT &
INFLUENZA
IMMUNIZATION SUMMIT
NEWS & INFORMATION
NEWSLETTER SIGN UP
OFFICIAL RELEASES
ACIP
CDC
FDA
PACKAGE INSERTS
PARTNERS
PHARMACISTS
PHOTOS
POWERPOINT SLIDE SETS
PREGNANCY AND
VACCINES
PRESS ROOM
PROTECT NEWBORNS
FROM HEP B
PUBLICATIONS
IAC Express
Vaccinating Adults:
   A Step-by-Step Guide
Hepatitis B What Hospitals
   Need to Do to
   Protect Newborns
Needle Tips Archive
Vaccinate Adults Archive
Vaccinate Women Archive
REGISTRIES
SCHOOL VACCINATION REQUIREMENTS
SHOP IAC
DVD Immunization Techniques
Laminated Schedules
Patient Record Cards
Flu Vaccine Buttons and Stickers
"Vaccines Save Lives" Pins
SITE MAP
SLIDE SETS
STANDING ORDERS
STATE INFORMATION
Immunization Websites
Laws and Mandates for School Entry
Immunization Program Managers
SUBSCRIBE TO IAC EXPRESS
SUPPORT IAC
TALKING ABOUT VACCINES
Adjuvants & Ingredients
Autism
Importance of Vaccination
MMR Vaccine
Religious Concerns
Vaccine Safety
>> view all
TECHNICALLY SPEAKING
TRANSLATIONS
IAC Handouts
VISs
TRAVEL (INTERNATIONAL)
UNPROTECTED PEOPLE
STORIES
Chickenpox
Hepatitis B
Measles
Whooping Cough
>> view all
VACCINATING ADULTS:
A STEP-BY-STEP GUIDE
VACCINE INFORMATION
STATEMENTS
Translations
VACCINE
MANUFACTURERS
VACCINE POLICY &
LICENSURE
ACIP
FDA
WHO
VACCINE SAFETY
VACCINE TIMELINE
VACCINES
Hepatitis B
HPV (Human papillomavirus)
Influenza
Pertussis
Varicella
>> view all
VIDEO OF THE WEEK
VIDEO LIBRARY
VISs
Translations
WHAT'S NEW OR UPDATED AT IAC
Handouts
VISs and Translations
Web Pages
 
Immunization Action Coalition  •  2550 University Avenue West  •  Suite 415 North  •  Saint Paul, Minnesota  •  55114
tel 651-647-9009  •  fax 651-647-9131
 
 
 
This website is supported in part by a cooperative agreement from the National Center for Immunization and Respiratory Diseases (Grant No. 6NH23IP22550) at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. The website content is the sole responsibility of IAC and does not necessarily represent the official views of CDC.