Doxylamine and phenylephrine

Doxylamine is an antihistamine that helps lessen the effects of histamine, a natural chemical in the body. Histamine can lead to symptoms like sneezing, itching, watery eyes, and a runny nose.

Phenylephrine is a decongestant that helps narrow blood vessels in the nasal passages. When blood vessels are enlarged, it can lead to nasal congestion (a stuffy nose).

Doxylamine and phenylephrine is a combination medicine used to treat a runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Doxylamine and phenylephrine may also be used for other reasons not mentioned in this medication guide.

Use exactly as directed on the label, or as prescribed by your doctor. Cold or cough medicine is only for short-term use until your symptoms clear up.

Swallow the tablet whole and do not crush, chew, or break it.

Always follow directions on the medicine label about giving cough or cold medicine to a child. Do not use the medicine only to make a child sleepy. Death can occur from the misuse of cough or cold medicines in very young children.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Do not use this medicine only to make a child sleepy.

You should not use doxylamine and phenylephrine if you are allergic to doxylamine or phenylephrine.

Do not use doxylamine and phenylephrine if you have taken an MAO inhibitor in the last 14 days. A serious drug interaction could happen. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Ask a doctor or pharmacist if this medicine is safe for you to use if you have:

• asthma or other breathing issues like emphysema or chronic bronchitis;
• high blood pressure or heart disease;
• glaucoma;
• diabetes;
• kidney disease; or
• a thyroid disorder.

Ask a doctor before using this medicine if you are pregnant or breastfeeding.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

doxylamine and phenylephrine may cause serious side effects. Stop using doxylamine and phenylephrine and call your doctor right away if you have:

• severe dizziness;
• nervousness, trouble sleeping;
• little or no urination; or
• high blood pressure (severe headache, pounding in your neck or ears).

Common side effects of doxylamine and phenylephrine may include:

• dizziness, drowsiness;
• dry mouth, nose, or throat;
• constipation;
• blurred vision; or
• feeling restless or excited (especially in children).

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Since doxylamine and phenylephrine is taken as needed, you might not have a regular dosing schedule. If you miss a dose and it’s almost time for your next dose, just skip the missed dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Avoid driving or hazardous activity until you know how doxylamine and phenylephrine will affect you. Your reactions could be impaired.

• Ask a doctor or pharmacist before using other cough or cold medicines that may contain similar ingredients.

• Drinking alcohol can increase certain side effects of doxylamine.

Avoid using this medicine with other drugs that cause drowsiness or slow your breathing (such as opioid medicine, a muscle relaxer, or medicine for anxiety or seizures).

Ask a doctor or pharmacist before using any other medication, including prescription and over-the-counter medicines, vitamins, and herbal products.

Not all possible drug interactions are listed in this medication guide.