Anaphylaxis is a severe, potentially life-threatening allergic reaction caused by contact with certain foods, medications, insect venom or latex. Anaphylaxis can also be caused by physical exercise.

If you've ever had anaphylaxis (also called an anaphylactic reaction) or you have a history of allergies or asthma, you may have a greater chance of having an anaphylactic reaction. To learn whether your child may be at risk talk to your Healthcare Professional.

Indications

EpiPen® and EpiPen Jr® Auto-Injectors (0.3 and 0.15 mg epinephrine) are for the emergency treatment of severe allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for patients who are at increased risk for these reactions.

EpiPen and EpiPen Jr Auto-Injectors are designed for you to use immediately in an emergency, to treat an allergic reaction fast and give you time to get to a hospital or medical center. EpiPen and EpiPen Jr Auto-Injectors are not a substitute for emergency medical treatment.

Important Safety Information

Each EpiPen Auto-Injector contains a single dose of a medicine called epinephrine, which you inject into your outer thigh. DO NOT INJECT INTRAVENOUSLY. DO NOT INJECT INTO YOUR BUTTOCK, as this may not be effective for a severe allergic reaction. In case of accidental injection, please seek immediate medical treatment.

Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

Side effects may include an increase in heart rate, a stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These side effects usually go away quickly, especially if you rest. If you have high blood pressure or an overactive thyroid, these side effects may be more severe or longer lasting. If you have heart disease, you could experience chest pain (angina). If you have diabetes, your blood sugar levels may increase after use. If you have Parkinson's disease, your symptoms may temporarily get worse.

Talk to your healthcare professional to find out if you should be prescribed an EpiPen and EpiPen Jr Auto-Injector.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information please contact us at 800-395-3376