Doxylamine is an antihistamine. Depending on your product, it may be used to help you fall asleep or used to relieve symptoms of allergy, hay fever, and the common cold. This medication works by blocking certain natural substances (histamine, acetylcholine) that your body makes. This effect causes drowsiness and also helps to relieve allergy/cold symptoms such as watery eyes, runny nose, and sneezing.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Doxylamine products used as a sleep aid (such as 25-milligram tablet) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Read all directions on the product package before taking this medication. If you have any questions, consult your pharmacist.

Take this medication by mouth with or without food. Follow the directions for dosing on the label, or take as directed by your doctor. This medication may be taken with food or milk if stomach upset occurs.

If you are using the chewable form of this medication, chew thoroughly and then swallow.

If you are using the liquid form of this medication, measure the dose carefully using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

If you are using this product to help you sleep, take this medication about 30 minutes before bedtime. If you continue to have trouble sleeping for longer than 2 weeks, contact your doctor. Ongoing trouble sleeping may be a symptom of a serious medical problem and should be checked by a doctor.

Do not take more medication than recommended or take it more often without consulting your doctor. Your dosage is based on your age, medical condition, and response to therapy.

Drowsiness, dizziness, headache, constipation, stomach upset, blurred vision, decreased coordination, or dry mouth/nose/throat may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., hallucinations, irritability, nervousness), ringing in the ears, trouble urinating.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, fast/irregular heartbeat, seizure.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking doxylamine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (e.g., asthma, emphysema), a certain eye problem (glaucoma), heart problems, high blood pressure, liver disease, seizures, stomach problems (e.g., ulcers, blockage), overactive thyroid (hyperthyroidism), urination problems (e.g., trouble urinating due to enlarged prostate, urinary retention).

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit the use of alcohol and certain other medications that cause drowsiness. (See also Drug Interactions.)

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Liquid products may contain sugar. Caution is advised if you have diabetes. Ask your doctor or pharmacist about using this product safely.

The elderly may be more sensitive to the effects of this drug, especially dizziness, drowsiness, and low blood pressure.

Children may be more sensitive to the effects of antihistamines. In young children, this medication may cause agitation/excitement instead of drowsiness.

Tell your doctor if you are pregnant before using doxylamine. It should not be used during the last 3 months of pregnancy since antihistamines may increase the risk of serious side effects in a newborn baby (e.g., seizures). Discuss the risks and benefits with your doctor.

Based on information from related drugs, this medication may pass into breast milk. Consult your doctor before breast-feeding.

If you are taking this medication under your doctor's direction, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this product, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: antispasmodics (e.g., atropine, belladonna alkaloids), drugs for Parkinson's disease (e.g., anticholinergics such as benztropine, trihexyphenidyl), MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), scopolamine, tricyclic antidepressants (e.g., amitriptyline).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), other medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: large pupils, flushing, fever, hallucinations, weakness, shaking (tremor), muscle twitching, loss of consciousness, seizures. In children, excitement may occur first, and may be followed by loss of coordination, drowsiness, loss of consciousness, seizures.

Do not take for several days before allergy testing because test results can be affected.

Keep all regular medical and laboratory appointments.

Not applicable.

Refer to storage information printed on the package. If you have any questions about storage, ask your pharmacist. Keep all products away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised April 2009 Copyright(c) 2009 First DataBank, Inc.