Diphenhydramine

WHY is this medicine prescribed?

Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose, and cough caused by allergies or the common cold. Diphenhydramine is also used to treat insomnia (difficulty falling asleep or staying asleep) in adults, but should not be used to make a child sleepy.

Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Are there OTHER USES for this medicine?

Diphenhydramine is used to prevent and treat motion sickness.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Diphenhydramine comes as a tablet, a chewable tablet, a capsule, and a liquid to take by mouth. Take every 4 to 6 hours for relief of allergies, cold, and cough symptoms.

Do not take more or less of it or take it more often than prescribed by your doctor or directed on the label.

Diphenhydramine comes alone and also in combination with pain relievers, fever reducers, and medications to reduce congestion. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold product labels carefully before using two or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive too much medication.

Nonprescription cough and cold combination products, including products that contain diphenhydramine, can cause serious side effects or death in young children. Do not give these products to children younger than 2 years of age. Do not use in children between the ages of 2 and 5 years of age unless directed by your doctor. If you give these products to children 6 to 11 years of age, use caution. Do not give diphenhydramine products that are made for adults to children. Check the package label to find out how much medication the child should receive. Give the dose that matches the child's age on the chart. Ask the child's doctor if you don't know how much medication to give the child.

If you are taking the liquid, do not use a household spoon to measure your dose. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication.

What SPECIAL PRECAUTIONS should I follow?

Before taking diphenhydramine,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking diphenhydramine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had emphysema, chronic bronchitis, or other types of lung disease; glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision); or difficulty urinating (due to an enlarged prostate gland). If you have been told to follow a low-sodium diet, ask your doctor before using the liquid product.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking diphenhydramine, call your doctor.

• you should know that generally diphenhydramine should not be used in older adults, except to manage serious allergic reactions, because it is not as safe or effective as other medication(s) to treat your condition. If you are 65 years of age or older, talk to your doctor about the risks and benefits of taking this medication.

• you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

• remember that alcohol can add to the drowsiness caused by this medication. Avoid alcoholic beverages while you are taking this medication.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Diphenhydramine is usually taken as needed. If your doctor has told you to take diphenhydramine regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Diphenhydramine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dry mouth, nose, and throat
• drowsiness
• dizziness
• muscle weakness
• excitement (especially in children)

Some side effects may be serious. If you experience any of the following symptoms, call your doctor immediately:

• vision problems
• difficulty urinating or painful urination

Diphenhydramine may cause other side effects. Call your doctor if you experience any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Ask your pharmacist any questions you have about diphenhydramine.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.

^§ These products are not currently approved by the FDA for safety, effectiveness, and quality. Federal law generally requires that prescription drugs in the U.S. be shown to be both safe and effective prior to marketing. Please see the FDA website for more information on unapproved drugs (https://www.fda.gov/AboutFDA/Transparency/Basics/ucm213030.htm) and the approval process (https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm).