When This Medicine Should Not Be Used:
This vaccine is not right for every child. Your child should not receive this vaccine if he or she has had an allergic reaction to live rotavirus vaccine, has severe combined immunodeficiency disease (SCID), has a history of intussusception (a serious bowel problem), or was born with digestive problems that may cause intussusception, including a blocked bowel.

How to Use This Medicine:
Liquid

• A nurse or other trained health professional will give your child this vaccine. It is given by mouth.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: This vaccine needs to be given on a fixed schedule. If your child misses a scheduled dose, call right away for another appointment.

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

• Some medicines can affect how live rotavirus vaccine works. Tell your child's doctor if your child is receiving a treatment that may weaken the immune system, including steroid medicine (including cortisone, methylprednisone, prednisone, dexamethasone, hydrocortisone), radiation treatment, or medicine to treat cancer.

Warnings While Using This Medicine:

• Tell your child's doctor if your child has a weak immune system, HIV or AIDS, cancer, or has received a blood transfusion or blood products within the past 6 weeks. Tell your child's doctor if your child spends time with a person who has immune system problems or is receiving cancer treatment.
• Tell your child's doctor if your child has diarrhea, vomiting, or a fever. Your doctor may wait until your child is well before giving him the vaccine.
• The vaccine applicator may contain natural latex rubber. Tell your child's doctor if your child has had an allergic reaction to latex rubber.
• The vaccine may not protect every child who receives it from rotavirus infection.

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
• Fever, diarrhea, vomiting, red or black stools, severe stomach pain

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

• Cough or runny nose
• Fussiness or irritability
• Loss of appetite

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