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Diphenhydramine Elixir is used for:

Preventing or treating symptoms of hay fever and other upper respiratory allergies or the common cold, such as runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes, and relieving cough. It may also be used for other conditions as determined by your doctor.

Diphenhydramine Elixir is an antihistamine and anticholinergic. It works by blocking the action of histamine, reducing the symptoms of an allergic reaction. It also works in the brain to cause sedation.

Do NOT use Diphenhydramine Elixir if:

• you are allergic to any ingredient in Diphenhydramine Elixir or other similar medicines
• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Diphenhydramine Elixir:

Some medical conditions may interact with Diphenhydramine Elixir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a fast, slow, or irregular heartbeat
• if you have a history of asthma; chronic obstructive pulmonary disease (COPD); chronic bronchitis; lung problems (eg, emphysema); shortness of breath; sleep apnea; heart blood vessel problems; stroke; seizures; a blockage of your stomach, intestine, or bladder; difficulty urinating; diabetes; ulcers; an enlarged prostate or other prostate problems; glaucoma; heart problems; high blood pressure; porphyria; phenylketonuria; or an overactive thyroid

Some MEDICINES MAY INTERACT with Diphenhydramine Elixir. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Sodium oxybate (GHB) because an increase in sleep duration and a decrease in the ability to breathe are likely to occur
• Monoamine oxidase (MAO) inhibitors (eg, phenelzine) because they may increase side effects of Diphenhydramine Elixir

This may not be a complete list of all interactions that may occur. Ask your health care provider if Diphenhydramine Elixir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Diphenhydramine Elixir:

Use Diphenhydramine Elixir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Diphenhydramine Elixir may be taken with or without food.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Use Diphenhydramine Elixir exactly as directed on the package, unless instructed differently by your doctor. If you are taking Diphenhydramine Elixir without a prescription, follow any warnings and precautions on the label.
• If you miss a dose of Diphenhydramine Elixir and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Diphenhydramine Elixir.

Important safety information:

• Diphenhydramine Elixir may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Diphenhydramine Elixir. Using Diphenhydramine Elixir alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Diphenhydramine Elixir. Diphenhydramine Elixir will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Diphenhydramine Elixir may cause dizziness. Alcohol, hot weather, exercise, and fever can increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness.
• Do not become overheated in hot weather or during exercise or other activities since heatstroke may occur.
• If you are scheduled for allergy skin testing, do not take Diphenhydramine Elixir for several days before the test because it may decrease your response to the skin tests.
• Phenylketonuria patients - Diphenhydramine Elixir contains phenylalanine.
• Diphenhydramine Elixir may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Diphenhydramine Elixir. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• Do not use Diphenhydramine Elixir with any other medicine that contains diphenhydramine. Before you begin taking any new prescription or over-the-counter medicine, including one used on the skin, read the ingredients to see if it also contains diphenhydramine. If it does, or if you are uncertain if it does, contact your doctor or pharmacist.
• Do not use Diphenhydramine Elixir for persistent or chronic cough, such as that occurs with smoking, asthma, or emphysema, or if the cough is accompanied by excessive mucus, unless directed by a health care provider.
• If you are using Diphenhydramine Elixir for cough, cold, or allergy symptoms, stop use and contact your doctor if your symptoms do not improve within 7 days or are accompanied by fever.
• Use Diphenhydramine Elixir with caution in the ELDERLY because they may be more sensitive to its effects, especially dizziness, sedation, and lightheadedness upon standing.
• Safe use and instructions for use in CHILDREN differs according to the brand used. Talk to your doctor or pharmacist if you have any questions about the brand you are using.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Diphenhydramine Elixir during pregnancy. Diphenhydramine Elixir is excreted in breast milk. If you are or will be breast-feeding while you are using Diphenhydramine Elixir, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Diphenhydramine Elixir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; dry mouth, throat, and nose; excitability; thickening of mucus in nose or throat.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); convulsions; fast heartbeat or pounding in the chest; decreased alertness; hallucinations; tremor; wheezing.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include coma; excitement; hallucinations; loss of consciousness; muscle twitching; seizures; tremor; weakness.

Store Diphenhydramine Elixir at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Diphenhydramine Elixir out of the reach of children and away from pets.

General information:

• If you have any questions about Diphenhydramine Elixir, please talk with your doctor, pharmacist, or other health care provider.
• Diphenhydramine Elixir is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Diphenhydramine Elixir. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.