Uses of AK-Dilate:

• It makes the eye pupils larger.

What do I need to tell my doctor BEFORE I take AK-Dilate?

• If you have an allergy to phenylephrine or any other part of AK-Dilate (phenylephrine eye drops 10%).
• If you are allergic to AK-Dilate (phenylephrine eye drops 10%); any part of AK-Dilate (phenylephrine eye drops 10%); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Heart disease, high blood pressure, or thyroid disease.
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
• If your child is younger than 1 year of age. Do not give AK-Dilate (phenylephrine eye drops 10%) to a child younger than 1 year of age.

This is not a list of all drugs or health problems that interact with AK-Dilate (phenylephrine eye drops 10%).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take AK-Dilate (phenylephrine eye drops 10%) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take AK-Dilate?

• Tell all of your health care providers that you take AK-Dilate (phenylephrine eye drops 10%). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for clear eyesight while your pupils are dilated.
• If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
• Very bad heart problems like abnormal heartbeats and heart attack have happened with the 10% strength of AK-Dilate (phenylephrine eye drops 10%). Most of the time, these heart problems happened in people who had heart disease. Sometimes, they were deadly. If you have questions, talk with the doctor.
• Use with care in children younger than 5 years old. They may have more risk of high blood pressure.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using AK-Dilate (phenylephrine eye drops 10%) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (AK-Dilate) best taken?

Use AK-Dilate (phenylephrine eye drops 10%) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the eye only.
• Your doctor will give AK-Dilate (phenylephrine eye drops 10%).

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.

What are some other side effects of AK-Dilate?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stinging.
• Eye pain.
• Eye irritation.
• Blurred eyesight.
• Bright lights may bother you. Wear sunglasses.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out AK-Dilate?

• If you need to store AK-Dilate (phenylephrine eye drops 10%) at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about AK-Dilate (phenylephrine eye drops 10%), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.