November 28, 2015
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How Supplied


Fluzone® is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine.

Fluzone is approved for use in persons 6 months of age and older.


  • For intramuscular use only

Dose And Schedule

The dose and schedule for Fluzone are presented in Table 1.

Table 1: Dose and Schedule for Fluzone

Age Dose Schedule
6 months through 35 months One or two dosesa, 0.25 mL each If 2 doses, administer at least 1 month apart
36 months through 8 years One or two dosesa, 0.5 mL each If 2 doses, administer at least 1 month apart
9 years and older One dose, 0.5 mL -
a1 or 2 doses depends on vaccination history as per Advisory Committee on Immunization Practices annual recommendations on prevention and control of influenza with vaccines
“-” Indicates information is not applicable


Inspect Fluzone visually for particulate matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered.

Before administering a dose of vaccine, shake the prefilled syringe or multi-dose vial. Withdraw a single dose of vaccine using a sterile needle and syringe. Use a separate sterile needle and syringe for each dose withdrawn from the multi-dose vial.

The preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in persons ≥ 12 months through 35 months of age, or the deltoid muscle in persons ≥ 36 months of age. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

Do not administer this product intravenously or subcutaneously.

Fluzone should not be combined through reconstitution or mixed with any other vaccine.


Dosage Forms And Strengths

Fluzone is a suspension for injection.

Fluzone is supplied in 1 presentation:

1) Multi-dose vial, 5 mL, for persons 6 months of age and older.

Multi-dose vial, 5 mL (NDC 49281-396-78) (not made with natural rubber latex). Supplied as package of one (NDC 49281-396-15). A maximum of ten doses can be withdrawn from the multidose vial.

Storage And Handling

Store all Fluzone presentations refrigerated at 2° to 8 ° C (35 ° to 46 ° F). DO NOT FREEZE. Discard if vaccine has been frozen.

Between uses, return the multi-dose vial to the recommended storage conditions at 2 ° to 8 ° C (35 ° to 46 ° F).

Do not use after the expiration date shown on the label.

Manufactured by: Sanofi Pasteur Inc. Swiftwater PA 18370 USA. Revised: May 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/3/2015

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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