Doxylamine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Antihistamines can cause drowsiness and are sometimes used a sleep aids.

Doxylamine is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms.

Doxylamine is also used as a short-term treatment for sleep problems (insomnia).

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not use doxylamine to treat insomnia in a child younger than 12 years old. Ask a doctor before using this medicine to treat cold or allergy symptoms in a child younger than 6 years old. Always ask a doctor before giving a cold or allergy medicine to a child. Death can occur from the misuse of these medicines in very young children.

Take this medicine with food or milk if it upsets your stomach.

To treat insomnia, it is best to take doxylamine only when you can devote several hours to sleep. Follow your doctor's instructions.

Call your doctor if your cold or allergy symptoms do not improve after 7 days of treatment, or if your sleep problems do not improve after 2 weeks of treatment.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Insomnia:

25 mg orally once a day 30 minutes before bedtime.
Duration of Therapy: No more than 2 weeks consecutively.

Use: Helps to reduce difficulty in falling asleep.

Usual Pediatric Dose for Insomnia:

Age 12 Years and Older: 25 mg orally once a day 30 minutes before bedtime.
Duration of Therapy: No more than 2 weeks consecutively.

Use: Helps to reduce difficulty in falling asleep.

You should not use doxylamine if you are allergic to it.

Ask a doctor or pharmacist if it is safe for you to take doxylamine if you have other medical conditions, especially:

• glaucoma;

• an enlarged prostate;

• problems with urination; or

• asthma, bronchitis, emphysema, or other chronic lung disease.

Older adults may be more sensitive to the effects of this medicine.

Doxylamine is not expected to be harmful to an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

Doxylamine may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

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.

When treating insomnia, if it is almost your normal waking hour, skip the missed dose and wait until you are ready for bed again.

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

Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.

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).

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

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.

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

doxylamine may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Many combination medicines contain antihistamines. Taking certain products together can cause you to get too much of this medicine.

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine.

Drinking alcohol can increase certain side effects of doxylamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Doxylamine can decrease sweating and you may be more prone to heat stroke.

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

Doxylamine may cause serious side effects. Call your doctor at once if you have:

• confusion, hallucinations;

• severe dizziness or drowsiness; or

• little or no urinating.

Common side effects of doxylamine may include:

• blurred vision;

• dry mouth, nose, or throat;

• constipation; or

• mild dizziness or drowsiness.

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

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.

Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking doxylamine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Ask your pharmacist any questions you have about doxylamine.

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.

• Alka-Seltzer Plus® Night Cold Formula (containing Aspirin, Dextromethorphan, Doxylamine, Phenylephrine)
• Coricidin® HBP Nighttime Multi-Symptom Cold (containing Acetaminophen, Dextromethorphan, Doxylamine)
• Tylenol® Cold and Cough Nighttime (containing Acetaminophen, Dextromethorphan, Doxylamine)
• Vicks NyQuil® Cold and Flu Relief (containing Acetaminophen, Dextromethorphan, Doxylamine)
• Vicks NyQuil® Cold and Flu Symptom Relief Plus Vitamin C (containing Acetaminophen, Dextromethorphan, Doxylamine)
• Vicks NyQuil® Cough (containing Dextromethorphan, Doxylamine)
• Vicks NyQuil® Sinex Nighttime Sinus Relief (containing Acetaminophen, Doxylamine, Phenylephrine)
• Zicam® Multi-Symptom Cold and Flu Nighttime (containing Acetaminophen, Dextromethorphan, Doxylamine)