Tylenol Cold and Cough Nighttime (as a combination product containing Acetaminophen, Dextromethorphan, Doxylamine)

Name: Tylenol Cold and Cough Nighttime (as a combination product containing Acetaminophen, Dextromethorphan, Doxylamine)

Why is this medication prescribed?

Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

What special precautions should I follow?

Before taking doxylamine,

  • tell your doctor and pharmacist if you are allergic to doxylamine or any other medications.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: medications for colds, hay fever, or allergies; medications for depression; muscle relaxants; narcotic medications for pain; sedatives; sleep medications; and tranquilizers.
  • tell your doctor if you have or have ever had asthma, emphysema, chronic bronchitis, or other breathing problems; glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision); ulcers; difficulty urinating (due to an enlarged prostate gland); heart disease, high blood pressure, seizures,or an overactive thyroid gland.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking doxylamine, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking doxylamine.
  • you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
  • remember that alcohol can add to the drowsiness caused by this medication. Avoid alcoholic beverages while you are taking this medication.

What special dietary instructions should I follow?

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

What should I do if I forget a dose?

Doxylamine is usually taken as needed. If your doctor has told you to take doxylamine regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Doxylamine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • dry mouth, nose, and throat
  • drowsiness
  • nausea
  • increased chest congestion
  • headache
  • excitement
  • nervousness

If you experience any of the following symptoms, call your doctor immediately:

  • vision problems
  • difficulty urinating

Doxylamine may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

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).

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

Brand names

  • Aldex AN®
  • Nighttime Sleep Aid
  • Unisom® SleepTabs

Brand names of combination products

  • 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)
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