Indications

EpiPen^® (epinephrine injection, USP) 0.3 mg and EpiPen Jr^® (epinephrine injection, USP) 0.15 mg Auto-Injectors are for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions. EpiPen^® and EpiPen Jr^® are intended for immediate administration as emergency supportive therapy only. Seek immediate emergency medical help right away.

Important Safety Information

Use EpiPen^® or EpiPen Jr^® Auto-Injectors right away when you have an allergic emergency (anaphylaxis). Get emergency medical help right away. You may need further medical attention. Only a healthcare professional should give additional doses of epinephrine if you need more than two injections for a single anaphylactic episode. EpiPen^® or EpiPen Jr^® should only be injected into the middle of your outer thigh (upper leg), through clothing if necessary. Do not inject into your veins, buttocks, fingers, toes, hands or feet. Hold the leg of young children firmly in place before and during injection to prevent injuries. In case of accidental injection, please seek immediate medical treatment.

Rarely, patients who have used EpiPen^® or EpiPen Jr^® may develop an infection at the injection site within a few days. Some of these infections can be serious. Call your healthcare professional right away if you have any of the following at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.

Tell your healthcare professional about all of your medical conditions, especially if you have asthma, a history of depression, thyroid problems, Parkinson’s disease, diabetes, high blood pressure or heart problems, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Be sure to also tell your healthcare professional all the medicines you take, especially medicines for asthma. If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you use EpiPen^® or EpiPen Jr^®.

Common side effects include fast, irregular or “pounding” heartbeat, sweating, nausea or vomiting, breathing problems, paleness, dizziness, weakness, shakiness, headache, feelings of over excitement, nervousness or anxiety. These side effects usually go away quickly if you lie down and rest. Tell your healthcare professional if you have any side effect that bothers you or that does not go away.

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You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/Safety/MedWatch/ or call 1-800-FDA-1088.