When This Medicine Should Not Be Used:
You should not receive this vaccine if you have had an allergic reaction to any type of hepatitis A vaccine or to neomycin.

How to Use This Medicine:
Injectable

• A nurse or other health provider will give you this medicine.
• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
• You will receive a first dose of the vaccine and may get a second (booster) dose 6 to 12 months later.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using medicines that weaken your immune system, such as a steroid or cancer medicine. Tell your doctor if you are using a blood thinner (such as warfarin, Coumadin®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you or your child have liver disease, a bleeding problem (such as hemophilia), a weak immune system from a disease or medicine, or severe illness with a fever.
• Tell your doctor if you have a cold or the flu, especially if you have a fever. You may need to wait until you are well to receive this vaccine.
• Your first shot of the vaccine should be given at least 2 weeks before you may be exposed to the hepatitis A virus. If you already have been exposed to the hepatitis A virus or if you need longer-term protection, you may receive an immune globulin shot when you get the hepatitis A vaccine.
• This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or trouble breathing after you get the injection.
• Tell your doctor if you or your child are allergic to latex. The needle cover and the rubber plunger of the prefilled syringe contain dry natural latex rubber, which may cause an allergic reaction in people with a latex allergy.
• This vaccine may not protect you against hepatitis A infection if you are already infected with the virus at the time you receive the shot.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Chills, cough, runny or stuffy nose, sore throat, and body aches.
• Fever of 99.5 degrees F or higher.
• Swollen, painful, or tender lymph glands in your neck, armpit, or groin.
• Unusual bleeding or bruising.
• Unusual tiredness or weakness.
• Yellowing of the skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, vomiting, loss of appetite, stomach pain, or upset stomach.
• Headache.
• Mild skin rash.
• Pain, redness, swelling, itching, bruising, or a lump where the shot was given.
• Tiredness.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088