Doxylamine is an antihistamine, 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 helps to relieve allergy/cold symptoms such as watery eyes, runny nose, and sneezing. Doxylamine is also used to help you relax and fall asleep.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Also, do not give the 25 milligram tablets to children younger than 12 years, unless directed by the doctor. 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).

Follow all directions on the product package. If your doctor has prescribed this medication, take it as directed. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food. 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.

The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose or take this medication more often than directed.

To help you sleep, take this medication about 30 minutes before bedtime. If you continue to have difficulty sleeping for longer than 2 weeks, contact your doctor.

If your condition lasts or gets worse, or if you think you may have a serious medical problem, get medical help right away.

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

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

If your doctor has directed you to use this medication, remember that your doctor 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 right away if you have any serious side effects, including:

• mental/mood changes (such as hallucinations, irritability, nervousness, confusion)
• ringing in the ears
• trouble urinating
• easy bruising/bleeding
• fast/irregular heartbeat

Get medical help right away if you have any very serious side effects, including:

• seizure

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• 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 or at www.fda.gov/medwatch.

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. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• breathing problems (such as asthma, emphysema)
• a certain eye problem (glaucoma)
• heart problems
• high blood pressure
• liver disease
• seizures
• stomach problems (such as ulcers, blockage)
• overactive thyroid (hyperthyroidism)
• urination problems (such as trouble urinating due to enlarged prostate, urinary retention)

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, low blood pressure, confusion, constipation, or trouble urinating. Drowsiness, dizziness, and confusion can increase the risk of falling.

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

This product is safe to use during pregnancy.

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

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray)

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain lab tests (such as urine drug screening tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. 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 medical and lab 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.