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Medications and Drugs

Brand Names: Aldex AN, Unisom

Generic Name: doxylamine (Pronunciation: dox IL a meen)

What is doxylamine (Aldex AN, Unisom)?

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.

Doxylamine is used to treat sneezing, itching, watery eyes, and runny nose caused by allergies or the common cold.

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.

What are the possible side effects of doxylamine (Aldex AN, Unisom)?

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

Call your doctor at once if you have any of these serious side effects:

  • fast or uneven heart rate;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • blurred vision;
  • dry mouth;
  • nausea, stomach pain, constipation;
  • dizziness, drowsiness;
  • problems with memory or concentration;
  • ringing in your ears; 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.

What is the most important information I should know about doxylamine (Aldex AN, Unisom)?

You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, heart disease, or a thyroid disorder.

Ask a doctor or pharmacist about taking this medication if you have liver or kidney disease, an enlarged prostate, problems with urination, a blockage in your stomach or intestines, or a chronic lung disease such as bronchitis or emphysema.

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

This medication 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.

Drinking alcohol can increase certain side effects of doxylamine.



Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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