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.

Doxylamine and pyridoxine may also be used for purposes not listed in this medication guide.

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

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

Take doxylamine and pyridoxine on an empty stomach with a full glass of water.

Doxylamine and pyridoxine 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 doxylamine and pyridoxine.

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:

Doxylamine 10 mg-pyridoxine 10 mg delayed-release tablets:
-Initial dose: 2 tablets orally once a day at bedtime
-Maintenance dose: 2 tablets orally once a day to 4 tablets orally 3 times a day
-Maximum dose: 4 tablets/day

Doxylamine 20 mg-pyridoxine 20 mg extended-release tablets:
-Initial dose: 1 tablet orally once a day at bedtime
-Maximum dose: 2 tablets/day

Comments:
-Treatment should be taken as prescribed, and should not be taken on an as-needed basis.
-Patients should be routinely reassessed for the continued need for treatment.

Use: Treatment of nausea and vomiting of pregnancy in patients who do not respond to conservative management

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.

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 doxylamine and pyridoxine.

Doxylamine and pyridoxine 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). If your medication came with a desiccant canister (small canister that contains a substance that absorbs moisture to keep the medication dry), leave the canister in the bottle.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

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

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

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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects of doxylamine and pyridoxine 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 doxylamine and pyridoxine 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 doxylamine and pyridoxine, 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.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.