17.PATIENT COUNSELING INFORMATION
Vaccine Information Statements are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization to the patient, parent, or guardian. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines.)

Inform the patients, parents or guardians about:

Potential benefits and risks of immunization with Menactra vaccine.
Potential for adverse reactions that have been temporally associated with administration of Menactra vaccine or other vaccines containing similar components.
Reporting any adverse reactions to their healthcare provider.
The Sanofi Pasteur Inc. pregnancy registry, as appropriate.
Menactra vaccine is a registered trademark of Sanofi Pasteur Inc.

Manufactured by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

5977

PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Label

NDC 49281-589-05

MCV4
1 Dose
(0.5 mL)

Meningococcal
(Groups A, C, Y and
W-135) Polysaccharide
Diphtheria Toxoid
Conjugate Vaccine

Menactra®

Rx only

Mfd by: Sanofi Pasteur Inc.

PRINCIPAL DISPLAY PANEL - 0.5 mL Vial Carton

NDC 49281-589-05

MCV4

Meningococcal (Groups A, C, Y and
W-135) Polysaccharide Diphtheria
Toxoid Conjugate Vaccine

Menactra®

For 9 months through 55 years of age

5 VIALS
1 Dose
each

Rx only

sanofi pasteur

MENACTRA
neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen, neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen, neisseria meningitidis group y capsular polysaccharide diphtheria toxoid conjugate antigen, and neisseria meningitidis group w-135 capsular polysaccharide diphtheria toxoid conjugate antigen injection, solution
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-589
Route of Administration INTRAMUSCULAR DEA Schedule 
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN)  NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN 4ug in0.5mL
NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN)  NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN 4ug in0.5mL
NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN)  NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN 4ug in0.5mL
NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN)  NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN 4ug in0