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FDA Labeling Changes
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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.
There is currently no drug history available for this drug.
Fluzone (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution.
Fluzone suspension for injection is clear and slightly opalescent in color.
Antibiotics are not used in the manufacture of Fluzone.
No presentation of Fluzone is made with natural rubber latex.
Fluzone is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2015-2016 influenza season: A/California/07/2009 X-179A (H1N1), A/Switzerland/9715293/2013 NIB-88 (H3N2), and B/Phuket/3073/2013 (B Yamagata lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 6. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.
0.25 mL Dose
0.5 mL Dose
|"-" Indicates information is not applicable|
|* per United States Public Health Service (USPHS) requirement † Quantity Sufficient|
|Active Substance: Split influenza virus, inactivated strains*:||22.5 mcg HA total||45 mcg HA total|
|A (H1N1)||7.5 mcg HA||15 mcg HA|
|A (H3N2)||7.5 mcg HA||15 mcg HA|
|B||7.5 mcg HA||15 mcg HA|
|Sodium phosphate-buffered isotonic sodium chloride solution||QS† to appropriate volume||QS† to appropriate volume|
|Formaldehyde||≤50 mcg||≤100 mcg|
|Octylphenol ethoxylate||≤75 mcg||≤150 mcg|
|Multi-dose presentation (thimerosal)||12.5 mcg mercury||25 mcg mercury|