Generic Name: diphtheria/hepB/pertussis,acel/polio/tetanus

Brand Names: Pediarix

What is this medicine?

DIPHTHERIA TOXOID, TETANUS TOXOID, ACELLULAR PERTUSSIS VACCINE, DTaP; HEPATITIS B VACCINE, RECOMBINANT; INACTIVATED POLIOVIRUS VACCINE, IPV is used to prevent infections of diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis B, and poliovirus.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• infection with fever
• neurological disease
• seizure disorder
• an unusual or allergic reaction to vaccines, yeast, neomycin, polymyxin B, latex, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This vaccine is for injection into a muscle. It is given by a health care professional.

A copy of Vaccine Information Statements will be given before each vaccination. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 weeks old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up (booster) doses as directed. It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

• adalimumab
• anakinra
• infliximab
• medicines that suppress your immune system
• medicines to treat cancer
• steroid medicines like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check-ups as directed.

This vaccine, like all vaccines, may not fully protect everyone.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• blueish color to lips or nail beds
• breathing problems
• extreme changes in behavior
• fever over 101 degrees F
• inconsolable crying for 3 hours or more
• seizures
• unusual bruising or bleeding
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• aches or pains
• bruising, pain, swelling at site where injected
• diarrhea
• fussy
• low-grade fever
• loss of appetite
• sleepy
• vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.