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Brand names: All-Nite, Clear Cough® PM, Nite Time™, Tylenol® Cough and Sore Throat Nighttime

Acetaminophen; Dextromethorphan; Doxylamine oral liquid

What is Acetaminophen; Dextromethorphan; Doxylamine oral liquid?

ACETAMINOPHEN; DEXTROMETHORPHAN; DOXYLAMINE (e.g., Tylenol® Cough & Sore Throat Nighttime) is a combination of medicines used to relieve symptoms of cough, sore throat, and runny nose. Acetaminophen helps lower fever, and relieve body aches, headaches, or sore throat pain. Dextromethorphan helps to stop cough. Doxylamine is an antihistamine that relieves a runny nose.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
• alcohol use
• anemia or blood disease
• asthma, emphysema, bronchitis, or other lung disease
• chronic cough
• constipation
• difficulty passing urine or other bladder problems
• enlarged prostate
• G6PD deficiency
• glaucoma
• hardening of the arteries
• heart disease including angina, history of heart attack, blockage in heart vessels, heart failure, or enlarged heart
• hepatitis
• high blood pressure
• problems with immune system
• infection
• irregular heart beat
• kidney disease
• liver disease
• ulcers or other stomach or intestine problems (example: ulcerative colitis)
• an unusual reaction to acetaminophen, dextromethorphan, doxylamine, aspirin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should this medicine be used?

Take this medicine by mouth. Follow the directions on the label. Take it with food or milk if it upsets your stomach. Take your doses at regular intervals. Do not take your medicine more often than directed.

Try to avoid grapefruit juice while using this medicine because this may increase the chance of side effects from dextromethorphan.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What drug(s) may interact with Acetaminophen; Dextromethorphan; Doxylamine?

• amiodarone
• antacids
• aspirin or aspirin-like medicines
• busulfan
• celecoxib
• charcoal
• cholestyramine
• delavirdine
• disopyramide
• echinacea
• exenatide
• furazolidone
• gefitinib
• grapefruit juice
• imatinib
• isoniazid
• linezolid
• medicines known as MAO inhibitors (such as phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®))
• medicines for mental depression (such as fluoxetine (Prozac®), sertraline (Zoloft®), paroxetine (Paxil®))
• medicines for motion sickness
• medicines for Parkinson's disease or other movement disorders
• medicines that contain acetaminophen
• muscle relaxers (such as carisoprodol, cyclobenzaprine, orphenadrine)
• prilocaine
• procarbazine
• quinidine
• rifabutin
• rifampin
• ritonavir
• St. John's wort
• sulfinpyrazone
• terbinafine
• valdecoxib
• warfarin
• zidovudine

Because this product can cause drowsiness, other medicines that also cause drowsiness may increase this effect. Some medicines that cause drowsiness are:
• alcohol and alcohol-containing medicines
• barbiturate medicines for inducing sleep or treating seizures (convulsions)
• medicines for anxiety or sleeping problems, such as diazepam or temazepam
• medicines for hay fever and other allergies
• medicines for depression or psychotic disturbances
• prescription pain medicines

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Acetaminophen; Dextromethorphan; Doxylamine?

If you have a fever, skin rash, or persistent headache as well as a cough, see your prescriber. Do not treat yourself for fever longer than 3 days, or for cough or pain for longer than 7 days without consulting a health care professional. If your sore throat is severe, lasts more than 2 days, or if you also have a fever, headache, rash, nausea, and vomiting, see a health care professional immediately.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Alcohol can increase the chance of drowsiness, dizziness, confusion, or liver problems while using this medicine. Avoid alcoholic drinks. If you drink 3 or more alcoholic beverages every day, check with your doctor before taking medicines which contain acetaminophen because of the possibility of liver damage.

Do not smoke cigarettes. This may increase the chance of side effects from the medicine.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water will help.

Elderly patients over 60 years old may have a stronger reaction to this medicine and need smaller doses.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See an eye doctor if the problem does not go away or is severe.

What side effects may I notice from receiving Acetaminophen; Dextromethorphan; Doxylamine?

Side effects that you should report to your prescriber or health care professional as soon as possible:
• agitation, nervousness, excitability (especially in children)
• bloody stools
• confusion
• difficulty breathing, or wheezing
• difficulty urinating
• fever
• headache, especially if severe or gets worse
• high blood pressure
• irregular heartbeat or palpitations
• loss of appetite
• nausea/vomiting
• skin rash, redness, hives, or itching
• slurred speech
• swelling of face, tongue, or throat
• unusual bleeding or bruising, pinpoint red spots on the skin
• unusual tiredness or weakness
• yellowing of the skin or eyes

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• blurred vision
• constipation
• dizziness
• drowsiness
• fatigue
• increased appetite
• stomach ache

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Store at room temperature between 20—25 degrees C (68—77 degrees F). Do not transfer liquid preparations to another bottle or container. Protect from light and heat. Throw away any unused medicine after the expiration date.

Last updated: 5/17/2006 7:36:00 PM

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.