Doxylamine and pyridoxine tablets

What is this medicine?

DOXYLAMINE is an antihistamine that reduces the effects of natural chemical histamine in the body.

PYRIDOXINE is a form of vitamin B (B6).

Doxylamine and pyridoxine is a combination medicine used to treat nausea and vomiting during pregnancy, sometimes called morning sickness.

What should I tell my health care providers before I take this medicine?

Do not use doxylamine and pyridoxine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use this medicine if you are allergic to doxylamine or pyridoxine, or to other antihistamines such as Benadryl or Dramamine.

To make sure this medicine is safe for you, tell your doctor if you have:

• asthma or other breathing disorder;

• glaucoma, increased pressure inside your eye;

• blockage in your digestive tract (stomach or intestines);

• a stomach ulcer; or

• bladder obstruction or other urination problems.

FDA pregnancy category A. Doxylamine and pyridoxine is not expected to harm an unborn baby.

Doxylamine and pyridoxine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medication to anyone under 18 years old without medical advice.

How should I use this medicine?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not crush, chew, or break a delayed-release tablet. Swallow it whole.

Doxylamine and pyridoxine is usually taken at bedtime on an empty stomach, at least 2 hours after a meal.

If your symptoms do not improve, you may need to take 1 tablet in the morning, 1 tablet in the afternoon, and 2 tablets at bedtime. Follow your doctor's instructions.

Call your doctor if your symptoms get worse while using doxylamine and pyridoxine. Severe or ongoing vomiting can cause you to become dehydrated which can lead to serious medical problems.

What if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What may interact with this medicine?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking doxylamine and pyridoxine with any medications you use to treat depression, mental illness, or seizures.

Other drugs may interact with doxylamine and pyridoxine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What side effects may I notice from this medicine?

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

Common side effects may include:

• drowsiness.

This is not a complete list of side effects and others may occur.

What should I watch for while using this medicine?

Doxylamine and pyridoxine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid drinking alcohol. It can increase drowsiness caused by doxylamine and pyridoxine.

Many medicines available over the counter can increase drowsiness caused by doxylamine and pyridoxine. Ask a doctor or pharmacist before using any cough/cold, allergy, pain, or sleep medication. Severe drowsiness can cause falls or other accidents.

Do not take any medicine without your doctor's advice while you are pregnant.