Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using EPIPEN JR?
EPIPEN JR contains the active ingredient adrenaline (epinephrine). EPIPEN JR is only
to be used for the immediate EMERGENCY TREATMENT of a SEVERE ALLERGIC REACTION (also
known as ANAPHYLAXIS).
2. What should I know before I use EPIPEN JR?
EPIPEN JR is a life-saving treatment in the emergency management of severe allergic
reactions. Therefore, it should not be withheld from anyone who is considered to need
it. It is important to know how to use an EPIPEN JR BEFORE a severe allergic reaction
causes a medical emergency. Talk to your doctor if your child has any other medical
conditions, or take any other medicines.
3. What if I am taking other medicines?
Some medicines may interfere with EPIPEN JR and affect how it works.
4. How do I use EPIPEN JR?
EPIPEN JR delivers one measured dose of adrenaline intended for a child who weighs
between 15 kg and 30 kg.
5. What should I know while using EPIPEN JR?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using EPIPEN JR.
Check the expiry date on EPIPEN JR and request for replacement prior to the expiry
date.
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Things you should not do
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Do not use EPIPEN JR to treat any other medical conditions including other types of
shock unless advised by the doctor.
Do not use EPIPEN JR if the solution is cloudy, coloured, contains sediment or the
viewing window is obscured.
Do not take off the blue safety release until required.
Do not touch the orange end on any person or object while you are taking off the blue
safety release and/or after you have taken off the blue safety release.
Do not inject into hands, feet, ears, nose, buttocks, genital area or into blood vessels.
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Driving or using machines
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Your ability to drive and use machines may be affected by the anaphylactic reaction
and possible adverse effects to adrenaline.
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Drinking alcohol
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Alcohol may increase the effects of this medicine.
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Looking after your medicine
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Keep the Auto-Injector in the protective carry tube until required. Protect from light.
Store below 25°C. Temperature excursions between 15°C to 25°C permitted. Do not refrigerate.
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6. Are there any side effects?
Tell your doctor or pharmacist if your child experiences a fast or noticeable heartbeat,
difficulty breathing, chest pain or shortness of breath. This is not a complete list of all possible side effects.
Active ingredient(s):
adrenaline (epinephrine)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using EPIPEN JR. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using EPIPEN JR.
Where to find information in this leaflet:
1. Why am I using EPIPEN JR?
EPIPEN JR contains the active ingredient adrenaline (epinephrine). Adrenaline belongs to a group of medicines called adrenergic and dopaminergic agents
which are classified as cardiac stimulants. In some countries, adrenaline is known
as epinephrine.
Adrenaline is a natural hormone released in response to stress. Adrenaline is known
to:
shrinks abnormally wide blood vessels and
makes the heart beat strongly
This helps improve the very low blood pressure and poor circulation that occur in
a severe allergic reaction.
Adrenaline also:
relaxes the lungs. This eases breathing and lessens wheezing.
helps stop:
swelling, for example, of the face, lips, throat, tongue, hands and feet;
skin rash and/or
itching
EPIPEN JR is only to be used for the immediate EMERGENCY TREATMENT of a SEVERE ALLERGIC
REACTION (also known as ANAPHYLAXIS). Your doctor or pharmacist will explain what
this is like, so that you know when you must use EPIPEN JR.
EPIPEN JR is used to treat children who have a severe allergic reaction caused by,
for example, hypersensitivity to
food
medicines
stinging insects
insect bites
latex or
other allergens, possibly unidentified.
Avoidance of known allergens is most important in preventing severe allergic reactions.
A severe allergic reaction, otherwise known as anaphylaxis, is overwhelming and life-threatening.
It affects the whole body, usually several parts of the body.
In particular:
heart and blood circulation
This may cause, for example, low blood pressure and collapse, or abnormal heartbeat
or function.
air passages and lungs
This causes difficulty in breathing, with noisy wheezing or gasping, possibly with
sneezing and a very runny nose.
stomach and bowels
This may cause nausea, vomiting, diarrhoea and abdominal cramps, often severe.
skin (very common)
This causes flushing, itching, skin rash, hives or swelling, which may be widespread
or in one part of the body.
brain
There may be fits or confusion due to lack of oxygen.
It is important to act quickly to treat a severe allergic reaction.
EPIPEN JR:
provides convenient first-aid
may be self-administered or administered by a carer to the child
has a spring-activated, hidden needle
automatically injects one pre-measured dose of adrenaline
is for single use only.
If you have any questions about this, talk to your doctor or pharmacist.
2. What should I know before I use EPIPEN JR?
The EPIPEN JR Auto-Injector is simple to use. Please read and follow the step-by-step
instructions.
Do not remove the blue safety release until you need to use EPIPEN JR and are ready
to use it. The safety release stops EPIPEN JR from “firing” or working.
Warnings
EPIPEN JR is a life-saving treatment in the emergency management of severe allergic
reactions. Therefore, it should not be withheld from anyone who is considered to need
it.
There is no visible needle. This helps overcome fear of injection. The hidden needle
is very fine so that the injection does not usually hurt.
The Auto-Injector has a clear viewing window so you can see the contents.
Do not use EPIPEN JR if:
the packaging is torn, doesn’t look quite right or shows signs of tampering
the contents:
are cloudy or
are coloured or
contain sediment or
if the viewing window is obscured
These changes indicate that the effectiveness of the drug product may be decreased.
When the viewing window is obscured, the Auto-Injector cannot be used again.
Help in using EPIPEN JR
It is important to know how to use an EPIPEN JR BEFORE a severe allergic reaction
causes a medical emergency.
Ask your doctor or pharmacist how you can get an EPIPEN Training Device for practice.
An EPIPEN Training Device is similar to the real EPIPEN JR. However, the EPIPEN Training
Device:
has NO medicine (adrenaline) and
has NO needle and
“fires” quietly and less forcefully
can be reset and reused.
Ask your doctor or pharmacist to show you how to practice with the EPIPEN Training
Device. If you practice using the EPIPEN Training Device, it will help you to learn
how to use the real EPIPEN JR.
It is important to regularly ask your doctor or pharmacist to demonstrate use with
an EPIPEN Training Device.
EPIPEN JR is effective as emergency treatment of a severe allergic reaction ONLY when
used according to the directions in this leaflet.
Give WITH CAUTION to those who have
high blood pressure
thyroid problems
high pressure in the eye (narrow-angle glaucoma).
If you have a thick-subcutaneous fat layer, there is a risk of the adrenaline not
reaching the muscle tissue resulting in a suboptimal effect. In such individuals there
may be a higher likelihood of needing a second injection with an additional EPIPEN
JR.
Take care also when giving EPIPEN JR to those:
having an anaesthetic
or who have:
diabetes
heart disease
allergy to EPIPEN JR
brain damage.
Check with your doctor or pharmacist if your child has:
heart disease or high blood pressure
Parkinson's disease
depression, or is on medication for depression
thyroid problems, or is on thyroid medication
diabetes
high pressure in the eye (narrow angle glaucoma)
asthma
ever had an allergic reaction to sodium metabisulfite
severe kidney problems
a tumor in your prostate (prostatic adenoma leading to residual urine)
high calcium levels or low potassium levels in your blood.
Talk to your doctor if you are allergic to sodium metabisulfite or any of the ingredients
listed at the end of this leaflet and have not consulted your doctor or specialist
beforehand.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
3. What if I am taking other medicines?
Tell your doctor or pharmacist if your child is taking any other medicines, including
any medicines, vitamins or supplements that you buy without a prescription from your
pharmacy, supermarket or health food shop.
Some medicines may interfere with EPIPEN JR and affect how it works. These include medicines for:
heart disease (e.g. digitalis (digoxin), quinidine, alpha and beta blocking medicines)
treatment of Parkinson’s disease (e.g. catechol-O-methyl transferase inhibitors or
levodopa)
depression (especially “tricyclic antidepressants” or monoamine oxidase inhibitors)
thyroid hormone (e.g. levothyroxine sodium or thyroid hormones)
diabetes
making you breathe more easily, used for asthma (e.g. theophylline)
use in labour (e.g. oxytocin)
acting on the nervous system (parasympatholytics)
treating allergies (antihistamines e.g. diphenhydramine or chlorpheniramine)
anaesthesia (e.g. halothane, cyclopropane or trichlorethylene).
These medicines may affect how well the adrenaline in EPIPEN JR works.
People with diabetes should carefully monitor their glucose levels after use of EPIPEN
or EPIPEN JR Auto-Injector as adrenaline can affect the amount of insulin made by
the body, thus increasing the blood glucose level.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements your child is taking and if these affect EPIPEN JR.
4. How do I use EPIPEN JR?
Follow carefully all directions given to you by your doctor or pharmacist.
They may differ from the information contained in this leaflet.
If you do not understand the instructions in this leaflet or on the EPIPEN JR Auto-Injector,
ask your doctor or pharmacist for help.
How much to use
For single use only. EPIPEN JR Auto-Injector delivers a fixed dose of adrenaline.
The EPIPEN JR Auto-Injector must be replaced immediately after use.
The dose will be decided by your doctor, who will adjust it individually for your
child.
Use in Children weighing between 15 kg and 30 kg
EPIPEN JR is intended for a child who weighs between 15 kg and 30 kg and has
been assessed by their doctor or pharmacist.
Note:
Selection of the appropriate dosage is determined according to the careful medical
assessment, patient's body weight and the severity of their symptoms. The doctor or
pharmacist may choose to recommend more or less than this amount.
For a child who weighs between 15 kg and 30 kg, the doctor or pharmacist may advise
EPIPEN Auto-Injector for the treatment of an anaphylactic attack after careful assessment
of their body weight and the severity of their symptoms.
There may be instances where the doctor or pharmacist will recommend the use of EPIPEN
JR in some adults, based on careful medical assessment.
If you have any questions about this, talk to your doctor or pharmacist.
When to use EPIPEN JR
Use EPIPEN JR immediately if your child has signs and symptoms of a severe allergic
reaction, as described by your doctor or pharmacist. Symptoms do vary. However, the
symptoms are likely to include:
collapse
difficulty in breathing
wheezing
swelling, especially of the face, lips, tongue or throat
flushing of the face
irregular or faint pulse
vomiting, diarrhoea, stomach cramps
skin rash, hives
itching
in some cases, loss of consciousness.
In case the first administration is not sufficient, you should carry two EPIPEN JR
Auto-Injector pens with you at all times.
How to use EPIPEN JR
Important Information - Before Use:
Before you ever need to use it, fully familiarise yourself with the EPIPEN JR Auto-Injector,
when and how it should be used.
It is recommended that your family members, carers, teachers are also instructed in
the correct use of the Auto-Injector.
Grip only the mid-section of the EPIPEN JR Auto-Injector. Avoid touching either end,
except when you remove the blue safety release. The blue safety release stops the
EPIPEN JR from “firing” or working.
Always point the orange end (which holds the needle) away from any part of any body,
except the planned injection site. This is the thigh of the child who has the severe
allergic reaction.
Always hold the leg firmly during injection especially in children who are uncooperative
and kick or move during an injection. This will reduce the risk of injection related
injuries.
Always keep the Auto-Injector away from the face and eyes.
Never inject the Auto-Injector into the buttock.
Carefully follow the step-by-step directions to make the EPIPEN JR work properly.
Step 1
Flip open the green cap on the protective carry tube.
Carefully tip and slide the EPIPEN JR Auto-Injector out of the carry tube.
Check the contents of the EPIPEN JR Auto-Injector through the viewing window. Make
sure the solution is clear, colourless and sediment-free.
Check the expiration date located on the side of the Auto-Injector. Replace the Auto-Injector
if the expiration date has passed.
Do not take off the blue safety release if you are not preparing for an injection.
Remember that the Auto-Injector is activated (“triggered”, ready to “fire”) as soon
as you take off the blue safety release.
Note:
To avoid an accidental injection, never place thumb, fingers or hand over the orange
end as this contains the needle. If an accidental injection happens, get medical help
right away.
Step 2
Make a fist around the EPIPEN JR Auto-Injector, with your thumb nearest to the blue
safety release (see FIGURE 1).
FIGURE 1
Step 3
Activate the EPIPEN JR Auto-Injector by removing the blue safety release with your
other hand (also shown in FIGURE 1). This “triggers” the EPIPEN JR. It is now ready
to
“fire” the needle and
inject the medicine through the needle into the child's thigh muscle.
After you remove the blue safety release:
Do not touch or place thumb, fingers or hand over the orange end as this contains
the needle.
Do not “click” on either end of the EPIPEN JR Auto-Injector. The Auto-Injector does
not work like a retractable ball-point pen.
Do not bump the EPIPEN JR Auto-Injector if you are not preparing for an injection.
This will help prevent accidental activation of the EPIPEN JR Auto-Injector prior
to use.
Step 4
Hold the EPIPEN JR Auto-Injector at a 90° angle (right angle) to the outer part of
the thigh. Hold the orange end about 5 cm away from the thigh (see FIGURE 2).
FIGURE 2
Step 5
Hold the child’s leg firmly, especially if they are uncooperative or may kick or move
during the injection.
Push the orange end FIRMLY into the child's outer mid-thigh until a “click” is heard
or felt.
Keep pressing the EPIPEN JR Auto-Injector firmly against the thigh for approximately
3 seconds (see FIGURE 3).
FIGURE 3
NOTE: EPIPEN JR may be used either
through clothing, as shown in FIGURE 3, or
directly on to skin.
When you press the orange end of the Auto-Injector firmly against the thigh, the hidden
needle “fires”. It injects the measured dose of adrenaline into the child's thigh
muscle.
Step 6
Carefully take the EPIPEN JR Auto-Injector away from the thigh. The orange needle
cover will extend to cover the needle (see FIGURE 4).
FIGURE 4
Check the viewing window - it should now be obscured. If the viewing window is not
obscured, repeat steps 2 to 6 above.
Step 7
Seek further medical attention for your child immediately. Although the child has
received adrenaline from EPIPEN JR, he/she may need more medical treatment.
Either
Contact your doctor or
Call an ambulance (telephone 000 in Australia). State that your child have had EPIPEN
JR (intramuscular adrenaline) even if symptoms appear to be improving.
While waiting for the ambulance your child should lie down with the feet raised unless
this makes your child breathless in which case your child should sit up. Stay with
your child until the ambulance arrives in case your child feels unwell again.
Unconscious patients should be placed on their side in the recovery position.
Step 8
Record the time EPIPEN JR was given.
Step 9
With severe, persistent allergic reactions, repeat injections with an additional EPIPEN
JR may be necessary. The EPIPEN JR dose may be repeated every 5 to 15 minutes if symptoms
recur or have not subsided. Two Auto-Injectors should always be carried in case a second dose is required.
Do not inject more than two sequential doses of EPIPEN JR unless under medical supervision. An overdose of adrenaline could cause harm.
Your child will need to go to hospital for observation and further treatment as required.
This is because the reaction may happen again at some time later.
Important Information - After Use
EPIPEN JR Auto-Injector is a single-use injectable device that delivers a fixed dose
of adrenaline.
The Auto-Injector cannot be reused. Do not try to reuse EPIPEN JR after the Auto-Injector has been activated.
The correct dose has been administered if the orange needle tip is extended and the
viewing window is blocked.
Do not tamper with the orange needle cover.
Do not replace the blue safety release.
After the Auto-Injector has been used, the extended needle cover will not fit back
into the carry tube.
Additional information about treatment of insect sting allergy
Use EPIPEN JR immediately if you or your child have been stung or bitten by the insect
and experience the signs and symptoms as described by your doctor or pharmacist.
If the insect’s sting is easily accessible, remove the sting with your fingernails.
Do not squeeze, pinch or push the sting deeper into the skin. If available, ice packs
or sodium bicarbonate soaks may then be applied to the stung area.
Keep warm, calm, and as still as possible.
If you use too much EPIPEN JR
Because each EPIPEN JR contains only one dose, overdosage is unlikely. Overdosage
may lead to a rise in blood pressure. This may cause bleeding in the brain or fluid
in the lung.
If you think that you have used too much EPIPEN JR, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using EPIPEN JR?
Things you should do
Check the expiry date on your EPIPEN JR and mark this expiry date on your calendar
or diary.
Also note on your calendar or diary to check the contents of your EPIPEN JR each month.
Do this through the viewing window.
Obtain a new EPIPEN JR immediately when:
the solution is brown or contains any particles or cloudiness
the viewing window is obscured. Return it to your doctor or pharmacist for disposal.
the Auto-Injector has previously been used
the Auto-Injector is about to expire.
The EPIPEN JR Auto-Injector can be damaged and made unusable if it is mishandled!
EPIPEN JR is NOT a toy. Keep it out of reach of children.
Things you should not do
Do not use EPIPEN JR to treat any other medical conditions including other types of
shock unless your doctor tells you to.
Do not use EPIPEN JR in a child who weighs more than 30 kg unless advised by your
doctor or pharmacist. EPIPEN is generally recommended for any adult or child who weighs
30 kg or more.
Do not use EPIPEN JR in a child who weighs below 15 kg
Talk to your doctor or pharmacist if this is the case so that a careful assessment
can be made and the appropriate dose is selected based on the individual’s weight
and the life-threatening nature of the reaction(s) for which EPIPEN is being prescribed.
Do not use EPIPEN JR if the solution is brown or contains any particles or cloudiness.
Do not touch the orange end on any person or object while you are taking off the blue
safety release and/or after you have taken off the blue safety release.
Do not inject into hands, feet, ears, nose, buttocks, genital area or into a blood
vessel.
If this does happen accidentally you must immediately seek medical attention. See
Section 6. Are there any side effects?
Driving or using machines
Your ability to drive and use machines may be affected by the anaphylactic reaction
and possible adverse effects to adrenaline.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may increase the effect of adrenaline.
Looking after your medicine
Always handle the EPIPEN JR Auto-Injector carefully, so as not to accidentally activate
it or make it “fire” or work.
Keep EPIPEN JR readily available with the person for whom it is intended.
Keep EPIPEN JR in the protective carry tube until required. Protect from light.
Store below 25°C. Temperature excursions between 15°C to 25°C permitted.
Do not store EPIPEN JR in the fridge.
Store EPIPEN JR in a cool dry place away from moisture, heat or sunlight; for example,
do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Extreme temperatures e.g. heat and dampness may cause the Auto-Injector unit to malfunction.
Follow the instructions in the carton on how to take care of your medicine properly.
Keep it where children cannot accidentally reach it.
When to discard your medicine
After use, do not just throw away the EPIPEN JR Auto-Injector.
Continue to handle the EPIPEN JR Auto-Injector safely and with care. Do this even
if you think the EPIPEN JR Auto-Injector has not “triggered”, “fired” or worked properly.
You CANNOT RE-USE the EPIPEN JR Auto-Injector even though some adrenaline is left
inside it.
Give your used EPIPEN JR to the doctor, pharmacist or to a hospital. This is for inspection,
if required, and also for safe disposal. The used EPIPEN JR should be placed in a
rigid sharps disposal unit.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Accidental injection into the hands, fingers or feet may result in the following:
fast or noticeable heart beat
pale skin colour at the site of accidental injection
feeling of coldness at the site of accidental injection
bruising or discolouration at the site of accidental injection
bleeding
skeletal injury.
If an accidental injection occurs at one of these areas, seek medical attention immediately.
Injection related injuries, such as needle cuts and bent needles, have been reported
in people who are uncooperative and kick or move during the injection.
Rare cases of serious skin infections have been reported following injection into
the buttock. In case of signs or symptoms of injection site infection, such as swelling, persistent
redness, heat (warmth) or pain (tenderness) always seek medical help immediately.
Sodium metabisulfite
EPIPEN JR contains a very small quantity of sodium metabisulfite as a preservative.
In people who are allergic to sodium metabisulfite, this could cause, for example,
severe allergic reactions (hypersensitivity) or breathing difficulty (bronchospasm)
in certain groups of people, especially those with history of asthma. However, the
active ingredient, adrenaline, in EPIPEN JR is expected to overcome any allergic reaction
to sodium metabisulfite. In an emergency, the risk of exposure to the very small amount
of sodium metabisulfite is generally outweighed by the benefits of EPIPEN JR.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is available with a doctor's prescription. You can also purchase it
directly from a pharmacy.
What EPIPEN JR contains
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Active ingredient
(main ingredient)
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Adrenaline (epinephrine) 150 micrograms in 0.3 mL
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Other ingredients
(inactive ingredients)
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sodium chloride
sodium metabisulfite
hydrochloric acid
Water for Injections
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Potential allergens
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Sulfites
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Consult your doctor or specialist if you are allergic to any of these ingredients.
What EPIPEN JR looks like
EPIPEN JR delivers one x 0.3 mL dose of adrenaline (epinephrine). This EPIPEN JR dose
provides
150 micrograms of adrenaline (epinephrine) (AUST R 42980).
The EPIPEN JR Auto-Injector holds 2 mL of adrenaline (epinephrine) 1:2,000 solution.
The EPIPEN JR Auto-Injector is packed in a non-waterproof protective plastic carry
tube. This carry tube has a green cap. The carry tube is supplied in a cardboard pack.
Who distributes EPIPEN JR
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in April 2025.
EPIPEN® is a Viatris company trade mark.
Made in USA
EPIPEN JR_cmi\Apr25/00