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VAXELIS is supplied in a single dose vial (NDC 63361-245-58) in packages of 10 vials (NDC 63361-245-10).
The vial stopper is not made with natural rubber latex.
VAXELIS should be stored at 2°C to 8°C (36°F to 46°F). Do not freeze. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.
Inform the parent or guardian of the following:
- The potential benefits and risks of immunization with VAXELIS.
- The common adverse reactions that have occurred following administration of VAXELIS or other vaccines containing similar ingredients.
- Other adverse reactions can occur. Call healthcare provider with any adverse reactions of concern.
Provide the Vaccine Information Statements (VIS), which are required by the National Childhood Vaccine Injury Act of 1986.
Sanofi Pasteur Limited
Toronto Ontario Canada
MCM Vaccine Co.
Swiftwater PA 18370 USA
Merck Sharp & Dohme Corp.
A subsidiary of Merck & Co., Inc.
Whitehouse Station NJ 08889 USA
and Sanofi Pasteur Inc.
Swiftwater PA 18370 USA
VAXELIS is a trademark of MCM Vaccine Company. The trademarks depicted herein are owned by their respective companies.
PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label
6 wks — 4 yrs
1 Dose (0.5 mL) IM
Diphtheria and Tetanus Toxoids
and Acellular Pertussis
Adsorbed, Inactivated Poliovirus,
Haemophilus b Conjugate
Conjugate) and Hepatitis B
Mfd by: Sanofi Pasteur Limited
10 VIALS — 1 Dose each
Diphtheria and Tetanus Toxoids and
Acellular Pertussis Adsorbed, Inactivated
Poliovirus, Haemophilus b Conjugate
(Meningococcal Protein Conjugate) and
Hepatitis B (Recombinant) Vaccine
For children 6 weeks through 4 years of age
MERCK SANOFI PASTEUR
|VAXELIS diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, haemophilus b conjugate (meningococcal protein conjugate) and hepatitis b (recombinant) vaccine injection, suspension|
|Labeler — MCM Vaccine Co. (079352454)|
|Sanofi Pasteur Limited||208206623||MANUFACTURE (63361-245)|
|Sanofi Pasteur SA||578763542||MANUFACTURE (63361-245)|
|Merck Sharp & Dohme Corp.||002387926||MANUFACTURE (63361-245)|
Revised: 04/2020 MCM Vaccine Co.
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