INDICATIONS (the following information applies to both EPIPEN and its Authorized Generic)

EPIPEN^® and EPIPEN JR^® Auto-Injectors are used to treat life-threatening, allergic emergencies in people who are at risk for or have a history of serious allergic emergencies. EPIPEN and EPIPEN JR are for immediate administration by you or your caregiver. They do not take the place of emergency medical care. You should get emergency help right away after using your EPIPEN or EPIPEN JR.

IMPORTANT SAFETY INFORMATION (the following information applies to both EPIPEN and its Authorized Generic)

EPIPEN^® (epinephrine injection, USP) 0.3 mg and EPIPEN JR^® (epinephrine injection, USP) 0.15 mg Auto-Injectors are used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life threatening and happen within minutes. If untreated, anaphylaxis can cause death. This allergic emergency can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes.

Always carry 2 EPIPEN or 2 EPIPEN JR Auto-Injectors with you because sometimes a single dose of epinephrine may not be enough to treat a serious allergic reaction before seeking medical care.

When you have an allergic emergency (anaphylaxis), use EPIPEN or EPIPEN JR auto-injectors right away. Get emergency medical help right away even if you have used the EPIPEN or EPIPEN JR auto-injector. You can use a second EPIPEN or EPIPEN JR auto-injector if symptoms continue or if the first auto-injector is activated. If you need more than 2 doses for an allergic emergency, they must be given by a healthcare provider.

Before you use EPIPEN or EPIPEN JR auto-injectors, tell your healthcare provider about all your medical conditions if you have heart problems with high blood pressure, diabetes, thyroid problems, asthma, a history of depression, Parkinson’s disease, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Tell your healthcare provider about all of your known allergies. 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 your EPIPEN or EPIPEN JR auto-injector.

Especially tell your healthcare provider if you take certain asthma medicines. EPIPEN and EPIPEN JR and other medicines may affect the way other medicines work. Other medicines may affect how EPIPEN and EPIPEN JR auto-injector works.

EPIPEN or EPIPEN JR auto-injector should 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. It is very important that you hold the EPIPEN or EPIPEN JR auto-injector down firmly on the middle of the outer thigh (upper leg) for at least 3 full seconds. If you do not hold it in place long enough, the EPIPEN or EPIPEN JR auto-injector might not have time to deliver the correct dose of medicine. If you accidentally inject EPIPEN or EPIPEN JR auto-injectors into any place other than the middle of your outer thigh, go to the nearest emergency room right away. If you inject a young child, hold their leg firmly in place before and during the 3 second injection to prevent injuries.

Rarely, patients who have used EPIPEN or EPIPEN JR auto-injectors may get infections 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.

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 may go away with rest. Tell your healthcare professional if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information and Patient Information for EPIPEN.

Please see the full Prescribing Information and Patient Information for the Authorized Generic for EPIPEN.