epinephrine

Epinephrine Injection is indicated for the emergency treatment of type I allergic reactions, including anaphylaxis in adult and pediatric patients who weigh 15 kg or greater.

• Injection: 0.3 mg (0.3 mg/0.3 mL) of clear and colorless solution in single-dose pre-filled auto-injector
• Injection: 0.15 mg (0.15 mg/0.15 mL) of clear and colorless solution in single-dose pre-filled auto-injector

None.

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Injection-Related Complications [see Warnings and Precautions (5.1)]
• Serious Infections at the Injections [see Warnings and Precautions (5.2)]
• Risks Associated with Use of Epinephrine in Certain Coexisting Conditions [see  Warnings and Precautions (5.3)]
• Allergic Reactions Associated with Sulfite [see Warnings and Precautions (5.4)]

The following adverse reactions associated with the use of epinephrine were identified in observational trials, case reports, studies, or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: angina, arrhythmias (including fatal ventricular fibrillation), cerebral hemorrhage, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy, and stress cardiomyopathy

Gastrointestinal Disorders: nausea and vomiting

Infections: Clostridial infections (gas gangrene)

Metabolism and Nutrition Disorders: transient hyperglycemia, sweating

Neurological: disorientation, impaired memory, panic, psychomotor agitation, sleepiness,

tingling, weakness, tremor, hypoesthesia, dizziness, headache

Psychiatric: anxiety, apprehensiveness, restlessness

Respiratory: respiratory difficulties

Skin and Subcutaneous Tissue Disorders: bruising, bleeding, discoloration, erythema, necrotizing fasciitis, myonecrosis

Overdosage of epinephrine has been reported to produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation.

Epinephrine overdosage can also cause transient bradycardia followed by tachycardia which may be accompanied by fatal cardiac arrhythmias; premature ventricular contractions followed by multifocal ventricular tachycardia; atrial tachycardia and occasionally by atrioventricular block; extreme pallor and coldness of the skin; metabolic acidosis; kidney failure.

Epinephrine is rapidly inactivated in the body and treatment following overdosage with epinephrine is primarily supportive. Treatment of epinephrine associated pulmonary edema consists of a rapidly acting alpha-adrenergic blocking drug (such as phentolamine mesylate) and respiratory support. Treatment of epinephrine associated arrhythmias consists of administration of a beta-adrenergic blocking drug (such as propranolol). If necessary, pressor effects may be counteracted by rapidly acting vasodilators or α-adrenergic blocking drugs. If prolonged hypotension follows such measures, it may be necessary to administer another pressor drug.

Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

Epinephrine Injection, USP 0.3 mg and 0.15 mg, are single-dose auto-injectors and combination products containing drug and device components.

Each Epinephrine Injection, USP 0.3 mg, delivers a single dose of 0.3 mg epinephrine from Epinephrine Injection, USP (0.3 mL) in a sterile solution.

Each Epinephrine Injection, USP 0.15 mg, delivers a single dose of 0.15 mg epinephrine from Epinephrine Injection, USP (0.15 mL) in a sterile solution.

Epinephrine Injection, USP 0.3 mg and Epinephrine Injection, USP 0.15 mg each contain 1.1 mL of epinephrine solution. 0.3 mL and 0.15 mL epinephrine solution are dispensed for Epinephrine Injection, USP 0.3 mg and Epinephrine Injection, USP 0.15 mg, respectively, when activated. The solution remaining after activation is not available for future use and should be discarded.

Each 0.3 mL in Epinephrine Injection, USP 0.3 mg, contains 0.3 mg epinephrine, 2.6 mg sodium chloride, not more than 1.5 mg chlorobutanol, 0.45 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0.

Each 0.15 mL in Epinephrine Injection, USP 0.15 mg, contains 0.15 mg epinephrine, 1.3 mg sodium chloride, not more than 0.75 mg chlorobutanol, 0.225 mg sodium bisulfite, hydrochloric acid and sodium hydroxide to adjust pH, and water for injection. The pH range is 2.2-5.0.

Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl]benzyl alcohol with the following structure:

Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the formation of melanin. Replace Epinephrine Injection, USP if the epinephrine solution appears discolored (pinkish or brown color), cloudy, or contains particles.

How Supplied

Epinephrine Injection is a clear and colorless solution for intramuscular or subcutaneous use. Epinephrine Injection is available as an auto-injector as described in Table 2.

Table 2            Epinephrine Injection Auto-injector Package Configurations and Strengths

Storage and Handling

• Protect from light. Epinephrine Injection is light sensitive and should be stored in the individual carrier tube provided.
• Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
• Do not refrigerate or freeze.
• Before using, check to make sure the solution in the auto-injector is clear and colorless.
• Replace the auto-injector if the solution is discolored (pinkish or brown color), cloudy, or contains particles.
• Properly dispose of all used, unwanted, or expired Epinephrine Injection, USP.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Administration

• Each Epinephrine Injection contains a single dose of epinephrine for single use.
• Instruct patients and/or caregivers to inspect the epinephrine solution visually through the viewing window periodically. Epinephrine Injection should be replaced if the epinephrine solution appears discolored, cloudy, or contains particles.
• Instruct patients and/or caregivers on proper intramuscular or subcutaneous injection technique using the Epinephrine Injection Trainer. A Trainer device is not provided with epinephrine injection. Patients and/or caregivers may obtain a Trainer device at www.epinephrineautoinject.com. Instructions for use of the Trainer device are provided on the Trainer label. Instruct patients and/or caregivers to use the Trainer to familiarize themselves with the use of epinephrine injection in an allergic emergency. The Trainer device may be used multiple times.

  For additional video instructions on the use of epinephrine injection,go to www.epinephrineautoinject.com.

• Instruct caregivers to hold the leg of young children or infants firmly in place and limit movement prior to and during injection. [see Warnings and Precautions (5.2)].
• Instruct patients and/or caregivers in the appropriate use of Epinephrine Injection.Epinephrine Injection should be injected into the middle of the outer thigh (through clothing if necessary).
• Instruct patients and/or caregivers when a second dose of Epinephrine Injection is needed. Administer a new Epinephrine Injection into the middle of the outer thigh starting 5 minutes after the first dose.
• Advise patients and/or caregivers when to seek emergency medical care for close monitoring of the type I allergic emergency and in the event that further treatment is required.

Injection-Related Complications

Advise patients to seek immediate medical care in the case of accidental injection into the digits, hands or feet because such an accidental injection to these areas may cause loss of blood flow to the affected area [see Warnings and Precautions (5.1)].

Serious Infections at the Injection Site

Advise patients that rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following injection of epinephrine for anaphylaxis. Instruct patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the Epinephrine Injection site [see Warnings and Precautions (5.2)].

Risks Associated with Certain Coexisting Conditions

Advise patients with coexisting conditions (cardiac arrhythmia and ischemia, coronary artery disease, hypertension, pulmonary edema, hyperthyroidism, renal impairment, Parkinson's disease, diabetes), for increased risks that may be associated with use of epinephrine [see Warnings and Precautions (5.3)].

Storage and Handling

Epinephrine Injection is light sensitive and should be stored in the individual carrier tube provided to protect it from light. The individual carrier tube is not waterproof. Instruct patients that Epinephrine Injection must be properly disposed of once the blue end caps have been removed or after use [see How Supplied/Storage and Handling (16)].

Manufactured for and Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

© 2025 Amneal Pharmaceuticals LLC. All rights reserved.

For inquiries call 1-877-835-5472

1871-05

Rev. 03-2026-05

Incorrect Use and Correct Use of Epinephrine Injection

For more information and video instructions on the use of Epinephrine Injection, go to www.epinephrineautoinject.com or call 1-877-835-5472.

This Patient Information has been approved by the U.S. Food and Drug Administration                                                                                   Rev. 03/2026

EPINEPHRINE injection (ep″ i nef′ rin),

for intramuscular or subcutaneous use

Epinephrine Injection USP, 0.3 mg

Each Epinephrine Injection USP, 0.3 mg delivers a single dose of 0.3 mg epinephrine USP in 0.3 mL (0.3 mg/0.3 mL)

Epinephrine Injection USP, 0.15 mg

Each Epinephrine Injection USP, 0.15 mg delivers a single dose of 0.15 mg epinephrine USP in 0.15 mL (0.15 mg/0.15 mL)

For allergic emergencies (anaphylaxis)

This Instructions for Use contains information on how to properly administer Epinephrine Injection.

Your Epinephrine Injection

Figure A. Epinephrine Injection, USP 0.3 mg (yellow label) and

Epinephrine Injection, USP 0.15 mg (orange label), showing the auto-injector and carrier tube components

Important Information You Need to Know Before Administering Epinephrine Injection

• Epinephrine Injection is a single-dose auto-injector used for allergic emergencies (anaphylaxis) and should be used right away.
• Before you need to use your Epinephrine Injection, make sure your healthcare provider shows you the right way to use it. Anyone who may be able to administer Epinephrine Injection should also understand how to use it.
• Check the expiration date on your Epinephrine Injection, as shown inFigure A. Replace it before the expiration date.
• Read this Instructions for Use carefully in a non-emergency situation and make sure you understand them before using your Epinephrine Injection. If you have any questions, ask your healthcare provider.
• It is very important to hold Epinephrine Injection firmly in place for a full 10 seconds. If you do not hold it in place long enough, Epinephrine Injection may not have time to deliver the full dose of medicine.
• Always carry 2 Epinephrine Injection devices. One dose may not be enough to treat an allergic emergency. You may need to use a second Epinephrine Injection if symptoms continue or come back after the first dose. A second dose may be administered starting 5 minutes after the first dose while you wait for emergency medical help, or if the first Epinephrine Injection is activated before the dose can be given.
• Inject Epinephrine Injection into the muscle (intramuscular) or under the skin (subcutaneous) in the middle of the outer thigh (upper leg) (see Figure B). Do not inject Epinephrine Injection into any other part of the body.
• If you accidentally inject Epinephrine Injection into the fingers, toes, hands or feet, administer a second dose of Epinephrine Injection into the middle of the outer thigh (upper leg).
• Epinephrine Injection can be administered through clothing if needed.

Figure B. Inject Epinephrine Injection into the middle of the outer thigh (upper leg)

Each Epinephrine Injection is for single use only.

The dose has been delivered if you see the needle sticking out of the red needle end after use. It is normal for most of the medicine to remain in the auto-injector after the dose is injected.

• Do not take the Epinephrine Injection apart.
• Do not remove the blue needle shield cap and blue end cap until you are ready to use Epinephrine Injection.
• Always point the red needle end downward (see Figure C). Never put your thumb, fingers, or hand over the red needle end. The needle comes out of the red needle end.
• Accidental injection into the fingers, hands, or feet may cause loss of blood flow to these areas. If an accidental injection happens, get emergency medical help right away.

Figure C. Correct way to hold the Epinephrine Injection with red needle end pointing down

Preparing to Inject Epinephrine Injection

Read the following information while preparing to inject Epinephrine Injection:

• Epinephrine Injectioncan be administered through clothing. Remove any objects or clothing that may block access to the injection site.
• Check Epinephrine Injectionbefore use. If the auto-injector appears damaged or broken, do not use it. Throw away (dispose of it) and use a new Epinephrine Injection.
• A separate Epinephrine Injection Trainer is available. The Trainer is beige in color and contains no medicine and no needle. Practice using the Trainer, but always carry your real Epinephrine Injection in case of an allergic emergency.
• You may request a separate Trainer at www.epinephrineautoinject.com or call 1-855-374-6374. Instructions for use of the Trainer device are provided on the Trainer label. Additional video instructions are available at www.epinephrineautoinject.com.
• Before injection, make sure you know where to inject (see Figure B) and how to hold the Epinephrine Injection (see Figure C).

Make sure Epinephrine Injection has not been used.

Epinephrine Injection has already been used if:

• the needle is sticking out of the red needle end, and
• the viewing window is blocked

Preparing to Inject a Child

• If you are administering Epinephrine Injection to a young child, hold their leg firmly in place before and during the 10 second injection to reduce the risk of injury.
• Ask your healthcare provider to show you how to:

1. Remove the blue needle shield cap first and then the blue end cap (see Figure D)
2. Hold the young child firmly in place (restrain movement).
3. With 1 hand, grip the auto-injector with the RED needle end pointing down.
4. Inject in the middle of the outer thigh (upper leg) (see Figure B).

d2

Figure D. Pull off the blue needle shield cap first and then the blue end cap

• Keep the Epinephrine Injection away from young children. The Epinephrine Injection is not a toy. Use by young children should be supervised by an adult.
• After the Epinephrine Injection is used, throw away both the blue needle shield cap and blue end cap immediately. These parts may pose a choking hazard for young children.

Checking the Solution Color

Examine the solution in the viewing window of your Epinephrine Injection regularly. See the information below:

Figure E. Solution Viewing Window

How to check the Solution Color:

• Remove Epinephrine Injection from the carrier tube. See Figure F.
• The solution can be seen through the viewing window located near the middle of the Epinephrine Injection. See Figure E.
• To check the solution color, hold the auto-injector in a well-lit area and look into the viewing window.

Solution Appearance

✓ Use Epinephrine Injection if the solution is clear and colorless.

X Do not use the Epinephrine Injection if the solution is discolored (pinkish or brown color), cloudy, or contains solid particles. Throw away (dispose of it) and use a new Epinephrine Injection (see “Disposing of an Expired, Unused or Used Epinephrine Injection” on the Patient Information).

Injecting Epinephrine Injection

Step 1. Remove Epinephrine Injection from the carrier tube. See Figure F.

f

Figure F

Step 2. Pull off the blue needle shield cap first by grasping at the ribbed area and pulling. You will now see a red needle end. Then pull off the blue end cap. See Figure G.

Important:

• The needle comes out of the red needle end.
• To avoid an accidental injection, never put your thumb, fingers or hand over the red needle end.
• If an accidental injection occurs, administer a second dose of Epinephrine Injection into the middle of the outer thigh (upper leg) and get emergency medical help right away.

Figure G

Step 3. Inject the Epinephrine Injection

Self Administration (see Figure H) or Caregiver Administration (see Figure I)

• Grasp the Epinephrine Injection firmly in your fist with the red needle end pointing downward. See Figure C.
• Place the red needle end against the middle of the outer thigh (upper leg) at a 90° angle (perpendicular) to the thigh. The injection may be given through clothing if necessary.
• Press Down Hard and hold Epinephrine Injectionfirmly against the thigh for a full 10 seconds to deliver the medicine. See Figure H and Figure I.

h

Figure H – Self Administration

I

Figure I – Caregiver Administration

• Only inject into the middle of the outer thigh (upper leg). Do not inject into any other part of the body.

Step 4. Remove the Auto-Injector

Pull Epinephrine Injection straight out at a 90° angle(perpendicular)from the outer thigh (upper leg).

• Massage the injection area for 10 seconds.
• Check the red needle end. The injection is complete and the correct dose has been delivered if you see the needle sticking out of the red needle end.
• If you do not see the needle, use a new Epinephrine Injection and repeat Step 3.
• Do not reuse the same Epinephrine Injection.

  Step 5. Get emergency medical help if needed.

  Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed, after using Epinephrine Injection. Before you receive Epinephrine Injection, your healthcare provider should talk to you about when to get emergency medical help.  

  Step 6. After use

  Warning: After Epinephrine Injection is activated, the needle does not retract back into the device.

  After use, carefully place the used Epinephrine Injectionback into the carrier tube to cover the needle.

• Place the labeled half of the carrier tube on a flat surface, with the opening facing upward.
• Using 1 hand, carefully slide the red needle end of Epinephrine Injection into the labeled half of the carrier tube until the needle is fully covered. See Figure J.

J

Figure J

• After the needle is inside the labeled half of the carrier tube, firmly push the unlabeled half of the carrier tube over the non-needle end of Epinephrine Injection until it is securely closed. See Figure K.

K

Figure K

• Take your used Epinephrine Injection with you when you go to see a healthcare provider.
• Tell the healthcare provider that you have received an injection of epinephrine. Show the healthcare provider where you received the injection.
• Give the used Epinephrine Injection to the healthcare provider for inspection and proper disposal.
• Ask your healthcare provider if you need a new prescription.

StoringEpinephrine Injection

• Store Epinephrine Injection at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Epinephrine Injection in the carrier tube to protect it from light and damage. The carrier tube is not waterproof.
• Do not expose Epinephrine Injection to extreme heat or cold. For example, do not store in your vehicle’s glove box and do not store it in the refrigerator or freezer.
• Keep Epinephrine Injection and all medicines out of the reach of children.

Disposing of Epinephrine Injection

Important: The blue needle shield cap and blue end cap are small parts and may pose a choking hazard for children. Throw away the blue needle shield cap and blue end cap immediately after using Epinephrine Injection.

• Epinephrine Injection has an expiration date. Replace it before the expiration date.
• For instructions on how to throw away (dispose of) expired, unused, or used Epinephrine Injection, see the section titled “Disposing of an Expired, Unused or Used Epinephrine Injection” on the Patient Information side of this leaflet.

For more information and video instructions on the use of Epinephrine Injection, visit www.epinephrineautoinject.com or call 1-877-835-5472.

© 2025 Amneal Pharmaceuticals LLC. All rights reserved.

Manufactured for and Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

1872-06

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised 03/2026