When This Medicine Should Not Be Used:
This vaccine should not be given to a child who has had an allergic reaction to Pediarix™ vaccine, to individual diphtheria, tetanus, pertussis, hepatitis B, or polio vaccines, or to other combination vaccines such as DTP or DTaP vaccines. Do not give this vaccine to a child who has had an allergic reaction to yeast, neomycin, or polymyxin B, or who has nervous system problems or seizures that are not under control. This vaccine should not be given to a child who has had seizures or collapsed within 7 days after receiving a pertussis vaccine.

How to Use This Medicine:
Injectable

• This vaccine is given only to children from the age of 6 weeks old up to the child's 7th birthday.
• Your doctor will prescribe your child's exact dose and tell you how often it should be given. This vaccine is given as a shot into one of the muscles.
• A nurse or other trained health professional will give your child this vaccine.
• This vaccine is usually given as a series of 3 shots about 6 to 8 weeks apart. Ask your child's doctor about your child's schedule, because it could be different.

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 your child is also using a blood thinner such as warfarin (Coumadin®). Tell your child's doctor if your child has recently received any kind of immune globulin.

Warnings While Using This Medicine:

• Make sure your doctor knows if your child has had a severe reaction to previous vaccinations of any kind. A severe reaction could be collapsing, crying constantly for longer than 3 hours, having a fever over 105 degrees, not being able to move (Guillain-Barre syndrome), or having seizures.
• Make sure your child's doctor knows if your child has bleeding problems, nervous system problems (such as seizures), or an allergy to latex rubber.
• Tell your child's doctor about all other vaccinations your child has had, especially if those vaccinations were part of a series. This vaccine can be used to finish some series of vaccinations, but not all. Tell your child's doctor if your child has ever received medicine for hepatitis B.
• Tell your child's doctor if your child is sick or has an infection (such as a cold or the flu). The doctor may want to wait until your child is well before giving the vaccination.
• Children who have problems with their immune systems may not be fully protected by this vaccine. Your child may have immune system problems if he or she is receiving chemotherapy for cancer, has HIV infection or AIDS, or is using a high dose of a steroid medicine such as prednisone. Because there may be some benefit, your child's doctor may still want to give the vaccine.

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
• Crying constantly for 3 hours or longer.
• Fever higher than 105 degrees F.
• Seizures, passing out.
• Sudden or severe weakness or numbness.

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

• Loss of appetite.
• Low fever.
• Mild fussiness, restlessness, or crying.
• Pain, redness, or swelling where the shot was given.
• Sleeping more than usual.

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