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Medications and Drugs

Brand Names: Diabetic Tussin Night Time Formula

Generic Name: acetaminophen, dextromethorphan, and diphenhydramine (Pronunciation: a SEET a MIN oh fen, DEX troe me THOR fan, DYE fen HYE dra meen)

What is acetaminophen, dextromethorphan, and diphenhydramine (Diabetic Tussin Night Time Formula)?

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Diphennydramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

The combination of acetaminophen, dextromethorphan, and diphenhydramine is used to treat sneezing, runny nose, itchy or watery eyes, cough, and pain or fever caused by the common cold or flu.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Acetaminophen, dextromethorphan, and diphenhydramine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of acetaminophen, dextromethorphan, and diphenhydramine (Diabetic Tussin Night Time Formula)?

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.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • confusion, hallucinations, unusual thoughts or behavior;
  • slow, shallow breathing;
  • urinating less than usual or not at all;
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild loss of appetite or stomach upset;
  • nausea, stomach pain, constipation;
  • blurred vision;
  • dry mouth;
  • 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 acetaminophen, dextromethorphan, and diphenhydramine (Diabetic Tussin Night Time Formula)?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Do not use any other cough, cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains acetaminophen (sometimes abbreviated as "APAP"), dextromethorphan, or diphenhydramine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver.

Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) per day.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.



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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