Diclegis is a delayed-release tablet containing a combination of doxylamine and pyridoxine. Doxylamine is an antihistamine that reduces the effects of natural chemical histamine in the body. Pyridoxine is a form of vitamin B (B6).

Diclegis is used to treat nausea and vomiting during pregnancy, sometimes called morning sickness.

Diclegis may also be used for purposes not listed in this medication guide.

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

Take Diclegis exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Diclegis on an empty stomach with a full glass of water.

Diclegis is either taken at bedtime, or at bedtime and in the morning. Follow your doctor's dosing instructions very carefully.

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

Call your doctor if your symptoms do not improve, or if they get worse. Severe or ongoing vomiting can cause you to become dehydrated which can lead to serious medical problems.

This medicine may affect a drug-screening urine test and you may have false results. Tell the laboratory staff that you use Diclegis.

Store at room temperature away from moisture and heat.

Keep the pills in their original container, along with the packet or canister of moisture-absorbing preservative.

Usual Adult Dose for Nausea/Vomiting:

During Pregnancy:

2 tablets orally at bedtime
Maximum dose: 4 tablets daily

Comments: Take daily and not on an as needed basis.

Do not use Diclegis 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.

Tell your doctor if you have ever had:

• 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.

You should not breast-feed while using Diclegis.

Diclegis is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Do not take more than 2 tablets or capsules in 24 hours.

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

Overdose symptoms may include dry mouth, extreme drowsiness or dizziness, confusion, restless feeling, dilated pupils, rapid heartbeats, seizure (convulsions), or muscle pain or weakness with fever and dark colored urine.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Avoid drinking alcohol. It can increase drowsiness caused by Diclegis.

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

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

Common Diclegis side effects may include:

• drowsiness.

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.

Using Diclegis with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may affect Diclegis, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.