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Fluzone is used for:

Protecting against certain strains of influenza. It is also known as the flu shot.

Fluzone is a vaccine. Although it is not fully understood, it is thought to work by stimulating the body to produce antibodies against certain strains of flu virus. The antibodies allow the body to more easily recognize and destroy these viruses, reducing the likelihood of infection and severity of the disease if infection does occur.

Do NOT use Fluzone if:

• you are allergic to any ingredient in Fluzone , including eggs, egg products, and chickens
• you have an uncontrolled nervous system disorder

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fluzone :

Some medical conditions may interact with Fluzone . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have an active infection (eg, acute respiratory tract infection), nervous system disorder, immune system problems, a bleeding disorder, or fever
• if you have a history of Guillain-Barre syndrome
• if you are having chemotherapy or radiation treatment

Some MEDICINES MAY INTERACT with Fluzone . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Corticosteroids (eg, prednisone) because they may decrease Fluzone 's effectiveness
• Phenytoin, theophylline, or warfarin because the risk of their side effects may be increased by Fluzone

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fluzone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fluzone :

Use Fluzone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fluzone is usually administered once a year in September, October, or November.
• Fluzone is administered as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
• If you miss a dose of Fluzone , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Fluzone .

Important safety information:

• Fluzone should not be given if you have a cold or fever at the time of injection.
• The length of protection from the virus is not known, nor is it a guarantee that the vaccine will protect everyone from the flu virus.
• Protection is not immediate, so it is necessary to be vaccinated before exposure.
• Fluzone only provides protection for 1 flu season (usually between December and March).
• Fluzone should not be used in CHILDREN younger than 6 months old; safety and effectiveness in these children have not been confirmed.
• Some brands of Fluzone are not approved for use in children. If the patient is a child, check with your doctor whether this brand is approved for children.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluzone while you are pregnant. If you are or will be breast-feeding while you use Fluzone , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fluzone :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Fever; general body discomfort; headache; muscle pain; redness, soreness, or a lump at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); shock; skin inflammation.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Fluzone is usually handled and stored by a health care provider. If you are using Fluzone at home, store Fluzone as directed by your pharmacist or health care provider. Keep this product, as well as syringes and needles, out of the reach of children and away from pets.

General information:

• If you have any questions about Fluzone , please talk with your doctor, pharmacist, or other health care provider.
• Fluzone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fluzone . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.