When This Medicine Should Not Be Used:
This vaccine should not be given to a child who has had an allergic reaction to the separate or combined diphtheria, tetanus, pertussis, polio, or Haemophilus b vaccines. This vaccine should not be given to a child who has had seizures, mood or mental changes, or lost consciousness within 7 days after receiving a pertussis vaccine. This vaccine should not be given to a child who has brain problems or seizures that are not controlled.

How to Use This Medicine:
Injectable, Injectable

• A nurse or other trained health professional will give your child this vaccine. The vaccine is given as a shot into one of your child's muscles. Your child will receive a series of 4 shots.
• Your child may receive other vaccines at the same time as this one. You should receive patient information sheets about all of the vaccines. Make sure you understand all of the information that is given to you.
• Your child may also receive medicines to help prevent or treat some minor side effects of the vaccine, such as fever and soreness.

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 uses a medicine that weakens the immune system, such as a steroid (such as hydrocortisone, methylprednisolone, prednisolone, prednisone), radiation treatment, or cancer medicine. This vaccine may not work as well if your child has a weak immune system.

Warnings While Using This Medicine:

• Make sure your child's doctor knows if your child has been sick or had a fever recently. Tell your doctor about all other vaccines your child has had. Tell your doctor about any reaction your child has had after receiving any type of vaccine. This includes fainting, seizures, a fever over 105 degrees F, crying that would not stop, or severe redness or swelling where the shot was given. Tell your doctor if your child has had Guillain-Barré syndrome after a tetanus vaccine.
• Make sure your doctor knows if your child was born prematurely. This vaccine may cause breathing problems in infants born prematurely.
• This vaccine will not treat an active infection. If your child has an infection due to diphtheria, tetanus, pertussis, polio, or Haemophilus influenzae type b, your child will need medicines to treat these infections.

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
• Bluish lips, skin, or nails
• Chills, cough, sore throat, body aches
• Crying constantly for 3 hours or more
• Fever over 105 degrees F
• Lightheadedness or fainting
• Seizures
• Severe muscle weakness, sleepiness, or drowsiness

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

• Fussiness or irritability
• Mild pain, redness, swelling, tenderness, 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