Generic Name: acetaminophen, chlorpheniramine, and phenylephrine (a SEET a MIN oh fen, KLOR fen EER a meen, FEN ill EFF rin)
Brand Names: Alka-Seltzer Plus Cold, Allergy Relief Multi-Symptom, Comtrex Flu Therapy, Comtrex Severe Cold & Sinus, Dristan Cold Multi Symptom Formula, Dryphen, Protid, Sinus Congestion & Pain Nighttime, Tylenol Allergy Multi-Symptom, Tylenol Children’s Plus Cold, Tylenol Sinus Congestion Nighttime

What is Tylenol Allergy Multi-Symptom (acetaminophen, chlorpheniramine, and phenylephrine)?

Acetaminophen is a pain reliever and fever reducer.

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

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen, chlorpheniramine, and phenylephrine is used to treat runny or stuffy nose, sinus congestion, sneezing, and pain or fever caused by allergies or the common cold.

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

What is the most important information I should know about Tylenol Allergy Multi-Symptom (acetaminophen, chlorpheniramine, and phenylephrine)?

There are many brands and forms of this medication available and not all brands are listed on this leaflet.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Do not use this medication 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. Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen (sometimes abbreviated as “APAP”), chlorpheniramine, or phenylephrine. 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.

What should I discuss with my healthcare provider before taking Tylenol Allergy Multi-Symptom (acetaminophen, chlorpheniramine, and phenylephrine)?

Do not use this medication 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 a decongestant before the MAO inhibitor has cleared from your body. Do not take this medication if you are allergic to acetaminophen, chlorpheniramine, or phenylephrine, or to other antihistamines or decongestants, diet pills, stimulants, or ADHD medications.

Ask a doctor or pharmacist about using acetaminophen, chlorpheniramine, and phenylephrine if you have:

• heart disease or high blood pressure;

• liver disease, alcoholism, or cirrhosis of the liver;

• glaucoma;

• kidney disease;

• diabetes;

• a thyroid disorder;

• an enlarged prostate; or

• problems with urination.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Tylenol Allergy Multi-Symptom (acetaminophen, chlorpheniramine, and phenylephrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine should be taken only for a short time until your symptoms clear up.

An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One acetaminophen, chlorpheniramine, and phenylephrine tablet may contain up to 500 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Take this medication with food or milk if it upsets your stomach. Drink extra fluids while you are taking acetaminophen, chlorpheniramine, and phenylephrine.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

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.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medication at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include feeling restless or nervous, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Tylenol Allergy Multi-Symptom (acetaminophen, chlorpheniramine, and phenylephrine)?

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”), chlorpheniramine, and phenylephrine are contained in many cold and pain medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, chlorpheniramine, or phenylephrine. 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. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Tylenol Allergy Multi-Symptom (acetaminophen, chlorpheniramine, and phenylephrine) side effects

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;

• confusion, hallucinations, unusual thoughts or behavior;

• severe dizziness, anxiety, restless feeling, or nervousness;

• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

• 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:

• blurred vision;

• dry mouth;

• mild loss of appetite;

• nausea, stomach pain, constipation;

• dizziness, drowsiness;

• problems with memory or concentration;

• ringing in your ears;

• restless or excitability (especially in children);

• sleep problems (insomnia);

• skin rash, redness, or itching; or

• warmth, tingling, or redness under your skin.

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 other drugs will affect Tylenol Allergy Multi-Symptom (acetaminophen, chlorpheniramine, and phenylephrine)?

Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine.

Also tell your doctor if you are using any of the following drugs:

• an antidepressant;

• a bronchodilator;

• a diuretic (water pill);

• gout medications;

• blood pressure medication;

• medication to treat irritable bowel syndrome;

• bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

• seizure medication;

• isoniazid;

• zidovudine (Retrovir, AZT);

• aspirin or salicylates (such as Disalcid, Doan’s Pills, Dolobid, Salflex, Tricosal, and others); or

• a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and there may be other drugs that can interact with acetaminophen, chlorpheniramine, and phenylephrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, chlorpheniramine, and phenylephrine.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 6.05. Revision Date: 08/07/2009 12:54:54 PM.

Generic name: Acetaminophen
Brand names: Tylenol, Aspirin Free Anacin

Why is Tylenol prescribed?

Tylenol is a fever- and pain-reducing medication that is widely used to relieve simple headaches and muscle aches; the minor aches and pains associated with the common cold; backache; toothache; minor pain of arthritis; and menstrual cramps.

Most important fact about Tylenol

Do not use Tylenol to relieve pain for more than 10 days, or to reduce fever for more than 3 days unless your doctor has specifically told you to do so.

How should you take Tylenol?

Follow the dosing instructions on the label. Do not take more Tylenol than is recommended.

–If you miss a dose…

Take Tylenol only as needed.

–Storage instructions…

Store at room temperature. Protect extra strength gelcaps and geltabs from high humidity and excessive heat. Keep the extended relief caplets away from high heat.

What side effects may occur?

Tylenol is relatively free of side effects. Rarely, an allergic reaction may occur. If you develop any allergic symptoms such as rash, hives, swelling, or difficulty breathing, stop taking Tylenol immediately and notify your doctor.

Special warnings about Tylenol

Stop taking Tylenol and check with your doctor if you develop new symptoms, if redness or swelling are present, if pain gets worse or lasts more than 10 days, or if fever gets worse or lasts more than 3 days. Children’s and Junior Strength Tylenol should not be used for more than 5 days for pain, or 3 days for fever.

If you generally drink 3 or more alcoholic beverages per day, check with your doctor about using Tylenol and other acetaminophen-containing products, and never take more than the recommended dosage. There is a possibility of damage to the liver when large amounts of alcohol and acetaminophen are combined.

Possible food and drug interactions when taking Tylenol

If Tylenol is taken with certain other drugs the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Tylenol with the following:

Alcohol
Cholestyramine (Questran)
Isoniazid (Nydrazid)
Nonsteroidal anti-inflammatory drugs such as Dolobid and Motrin
Oral Contraceptives
Phenytoin (Dilantin)
Warfarin (Coumadin)
Zidovudine (Retrovir)

Tylenol should not be used with other products containing acetaminophen.

Special information if you are pregnant or breastfeeding

As with all medications, ask your doctor or health care professional whether it is safe for you to use Tylenol while you are pregnant or breastfeeding.

Recommended dosage

ADULTS AND CHILDREN 12 YEARS AND OLDER

Tylenol Regular Strength

The usual dose is 2 tablets every 4 to 6 hours. Do not take more than 12 caplets or tablets in 24 hours.

Tylenol Extra Strength

The usual dose is 2 pills or tablespoonfuls every 4 to 6 hours. Do not take more than 8 pills or tablespoonfuls in 24 hours.

Tylenol Extended Relief

The usual dose is 2 caplets every 8 hours, not to exceed 6 caplets in any 24 hour period. Swallow each caplet whole. Do not crush, chew, or dissolve the caplets.

CHILDREN 6 TO 12 YEARS OLD

Tylenol Regular Strength

One-half to 1 tablet every 4 to 6 hours. Children in this age group should not be given more than 5 doses in 24 hours.

Junior Strength Tylenol

All doses of Junior Strength Tylenol chewable tablets may be repeated every 4 hours, up to 5 times a day. The usual dose for children 6 to 8 years of age is 2 tablets; 9 to 10 years, 2-1/2 tablets; 11 years, 3 tablets; 12 years, 4 tablets

Children’s Tylenol

All doses of Children’s Tylenol may be repeated every 4 hours, but not more than 5 times daily. Chewable tablets: The usual dose for children 6 to 8 years of age is 4 tablets; 9 to 10 years, 5 tablets; 11 to 12 years, 6 tablets. Suspension liquid: (A special cup for measuring dosage is provided.) The usual dose for children 6 to 8 years of age is 2 teaspoons; 9 to 10 years, 2-1/2 teaspoons; 11 to 12 years, 3 teaspoons.

CHILDREN UNDER 6 YEARS OLD

Children’s Tylenol

All doses of Children’s Tylenol may be repeated every 4 hours, but not more than 5 times daily. Children under 2 years old should be given Children’s Tylenol only on the advice of a physician. Chewable tablets: The usual dose for children 2 to 3 years of age is 2 tablets; 4 to 5 years, 3 tablets. Suspension liquid: (A special cup for measuring dosage is provided.) The usual dose for children 4 to 11 months of age is 1/2 teaspoon; 12 to 23 months, 3/4 teaspoon; 2 to 3 years, 1 teaspoon; 4 to 5 years, 1-1/2 teaspoons.

Infants’ Tylenol Concentrated Drops

The usual dose for children 0 to 3 months of age is 0.4 milliliter; 4 to 11 months, 0.8 milliliter; 12 to 23 months, 1.2 milliliters; 2 to 3 years, 1.6 milliliters.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately. Massive doses of Tylenol may cause liver damage.

• Symptoms of Tylenol overdose may include:
  Excessive perspiration, exhaustion, general discomfort, nausea, vomiting