Generic Name: acetaminophen and pseudoephedrine (a SEET a MIN oh fen and SOO doe ee FED rin)
Brand Names: Alka-Seltzer Cold and Sinus, Allerest No Drowsiness, Bayer Select Decongestant, Benadryl Allergy Sinus Headache, Dristan Cold Non-Drowsy, Ornex, Ornex Maximum Strength, Sinarest Sinus, Sine-Off Maximum Strength, Tavist Sinus, Triaminic Softchews Allergy Sinus, Tylenol Sinus Childrens

What is Tylenol Sinus Childrens (acetaminophen and pseudoephedrine)?

Acetaminophen is a pain reliever and fever reducer.

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

The combination of acetaminophen and pseudoephedrine is used to treat stuffy nose, sinus congestion, and pain or fever caused by the common cold.

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

What is the most important information I should know about Tylenol Sinus Childrens (acetaminophen and pseudoephedrine)?

Do not give this medication to a child younger than 2 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 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 take to see if it contains acetaminophen (sometimes abbreviated as “APAP”) or pseudoephedrine. If you drink more than three alcoholic beverages per day, do not take this medication without your doctor’s advice.

What should I discuss with my healthcare provider before taking Tylenol Sinus Childrens (acetaminophen and pseudoephedrine)?

Do not use this medication if you are allergic to acetaminophen or pseudoephedrine. 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.

Before taking acetaminophen and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:

• cirrhosis or other liver disease;

• a history of alcoholism;

• heart disease or high blood pressure;

• glaucoma;

• an enlarged prostate;

• diabetes; or

• a thyroid disorder.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before taking acetaminophen and pseudoephedrine, tell your doctor if you are pregnant or plan to become pregnant during treatment. Acetaminophen and pseudoephedrine 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 cough-and-cold medications 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 Sinus Childrens (acetaminophen and pseudoephedrine)?

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.

Drink extra fluids while you are taking acetaminophen and pseudoephedrine. 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 and pseudoephedrine tablet may contain up to 500 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. Do not give this medication to a child younger than 2 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.

Measure the liquid form of acetaminophen and pseudoephedrine 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.

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.

Overdose symptoms may include feeling restless or nervous, dizziness, drowsiness, nausea, vomiting, diarrhea, stomach pain, loss of appetite, increased sweating, seizure (convulsions), or coma.

What should I avoid while taking Tylenol Sinus Childrens (acetaminophen and pseudoephedrine)?

Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) and pseudoephedrine are contained in many combination medicines. 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, or pseudoephedrine. 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) of acetaminophen per day.

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.

Tylenol Sinus Childrens (acetaminophen and pseudoephedrine) 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;

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

• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

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

• warmth, tingling, or redness under your skin;

• feeling excited or restless;

• sleep problems (insomnia); or

• skin rash or itching;

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 Sinus Childrens (acetaminophen and pseudoephedrine)?

Before taking this medication, tell your doctor if you are using any of the following drugs:

• isoniazid;

• zidovudine (Retrovir, AZT);

• medicines to treat high blood pressure;

• gout medications such as probenecid (Benemid) or sulfinpyrazone;

• seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);

• stimulants (caffeine, diet pills, ADHD medications such as Ritalin or Adderall);

• an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others; or

• a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and there may be other drugs that can interact with acetaminophen and pseudoephedrine. 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 and pseudoephedrine.

• 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: 6.01. Revision Date: 01/26/2010 11:57:12 AM.

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 Sinus Congestion Nighttime (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 Sinus Congestion Nighttime (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 Sinus Congestion Nighttime (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 Sinus Congestion Nighttime (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 Sinus Congestion Nighttime (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 Sinus Congestion Nighttime (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 Sinus Congestion Nighttime (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/Doxylamine/Pseudoephedrine (a-seet-a-MIN-oh-fen/dox-IL-a-meen/sue-do-eh-FED-rin)
Brand Name: Tylenol Sinus Night Time

Tylenol Sinus Night Time is used for:

Relieving symptoms of pain, sinus congestion, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Tylenol Sinus Night Time is an analgesic, antihistamine, and decongestant combination. The analgesic works in the brain to decrease pain. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages.

Do NOT use Tylenol Sinus Night Time if:

• you are allergic to any ingredient in Tylenol Sinus Night Time
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
• you are unable to urinate or are having an asthma attack
• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tylenol Sinus Night Time:

Some medical conditions may interact with Tylenol Sinus Night Time. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a fast, slow, or irregular heartbeat
• if you have a history of adrenal gland problems (eg, adrenal gland tumor); asthma; severe kidney problems; lung problems (eg, emphysema); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; an overactive thyroid; or liver problems; or if you consume more than 3 alcohol-containing drinks per day

Some MEDICINES MAY INTERACT with Tylenol Sinus Night Time. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Tylenol Sinus Night Time may be increased
• Anticoagulants (eg, warfarin), digoxin, or droxidopa because risk of bleeding, irregular heartbeat or heart attack may be increased
• Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Tylenol Sinus Night Time
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Tylenol Sinus Night Time

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol Sinus Night Time may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tylenol Sinus Night Time:

Use Tylenol Sinus Night Time as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tylenol Sinus Night Time may be taken with or without food.
• If you miss a dose of Tylenol Sinus Night Time, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tylenol Sinus Night Time.

Important safety information:

• Tylenol Sinus Night Time may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tylenol Sinus Night Time. Using Tylenol Sinus Night Time alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Do not take diet or appetite control medicines while you are taking Tylenol Sinus Night Time without checking with your doctor.
• Tylenol Sinus Night Time contains acetaminophen, doxylamine, and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen, doxylamine, or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
• Do NOT exceed the recommended dose or take Tylenol Sinus Night Time for longer than prescribed without checking with your doctor.
• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
• Tylenol Sinus Night Time may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Tylenol Sinus Night Time. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• Tylenol Sinus Night Time may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Tylenol Sinus Night Time or other pain relievers/fever reducers. Alcohol use combined with Tylenol Sinus Night Time may increase your risk for liver damage.
• If you are scheduled for allergy skin testing, do not take Tylenol Sinus Night Time for several days before the test because it may decrease your response to the skin tests.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Tylenol Sinus Night Time.
• Use Tylenol Sinus Night Time with caution in the ELDERLY because they may be more sensitive to its effects.
• Caution is advised when using Tylenol Sinus Night Time in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Tylenol Sinus Night Time, discuss with your doctor the benefits and risks of using Tylenol Sinus Night Time during pregnancy. It is unknown if Tylenol Sinus Night Time is excreted in breast milk. Do not breast-feed while taking Tylenol Sinus Night Time.

Possible side effects of Tylenol Sinus Night Time:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; trouble sleeping; vision changes; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Tylenol Sinus Night Time:

Store Tylenol Sinus Night Time at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylenol Sinus Night Time out of the reach of children and away from pets.

General information:

• If you have any questions about Tylenol Sinus Night Time, please talk with your doctor, pharmacist, or other health care provider.
• Tylenol Sinus Night Time is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Tylenol Sinus Night Time. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Acetaminophen/Diphenhydramine (a-SEET-a-MIN-oh-fen/DYE-fen-HYE-dra-meen)
Brand Name: Examples include Tylenol Cold Relief and Tylenol Severe Allergy

Tylenol Severe Allergy is used for:

Relieving cold and flu symptoms such as minor aches and pains, fever, headache, sore throat, muscle aches, sneezing, and runny nose. It may also be used for other conditions as determined by your doctor.

Tylenol Severe Allergy is an antihistamine and analgesic combination. Diphenhydramine causes drowsiness to help you fall asleep. Acetaminophen works in certain areas of the brain and nervous system to decrease pain.

Do NOT use Tylenol Severe Allergy if:

• you are allergic to any ingredient in Tylenol Severe Allergy
• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tylenol Severe Allergy:

Some medical conditions may interact with Tylenol Severe Allergy. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day
• if you have a fast, slow, or irregular heartbeat; liver problems (eg, hepatitis); or kidney problems
• if you have a history of asthma; lung problems (eg, emphysema); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate; seizures; or an overactive thyroid

Some MEDICINES MAY INTERACT with Tylenol Severe Allergy. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Furazolidone, isoniazid, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Tylenol Severe Allergy’s side effects
• Anticoagulants (eg, warfarin) because they may increase the risk of Tylenol Severe Allergy’s side effects, such as bleeding
• Beta-blockers (eg, propranolol) and hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Tylenol Severe Allergy

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol Severe Allergy may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tylenol Severe Allergy:

Use Tylenol Severe Allergy as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Tylenol Severe Allergy by mouth with or without food.
• If you miss a dose of Tylenol Severe Allergy, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tylenol Severe Allergy.

Important safety information:

• Tylenol Severe Allergy may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Tylenol Severe Allergy with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Avoid alcohol while you are using Tylenol Severe Allergy. Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tylenol Severe Allergy; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.
• If sore throat lasts more than 2 days or fever lasts more than 3 days, or if they get worse, check with your doctor.
• Tylenol Severe Allergy may harm your liver. Your risk may be greater if you drink alcohol while you are using Tylenol Severe Allergy. Talk to your doctor before you take Tylenol Severe Allergy or other fever reducers if you drink more than 3 drinks with alcohol per day.
• Tylenol Severe Allergy has acetaminophen and diphenhydramine. Before you start any new prescription or nonprescription medicine, check the label to see if it has acetaminophen or diphenhydramine in it too. If it does or if you are not sure, contact your doctor or pharmacist.
• Tylenol Severe Allergy may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Tylenol Severe Allergy. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Tylenol Severe Allergy may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Tylenol Severe Allergy for a few days before the tests.
• Tell your doctor or dentist that you take Tylenol Severe Allergy before you receive any medical or dental care, emergency care, or surgery.
• Use Tylenol Severe Allergy with caution in the ELDERLY; they may be more sensitive to its effects.
• Tylenol Severe Allergy should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• Tylenol Severe Allergy should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tylenol Severe Allergy while you are pregnant. It is not known if Tylenol Severe Allergy is found in breast milk. Do not breast-feed while taking Tylenol Severe Allergy.

Possible side effects of Tylenol Severe Allergy:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine or pale stools; difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe or persistent loss of appetite; stomach pain; tremor; trouble sleeping; unusual fatigue; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Tylenol Severe Allergy:

Store Tylenol Severe Allergy at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylenol Severe Allergy out of the reach of children and away from pets.

General information:

• If you have any questions about Tylenol Severe Allergy, please talk with your doctor, pharmacist, or other health care provider.
• Tylenol Severe Allergy is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Tylenol Severe Allergy. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: acetaminophen and diphenhydramine (a SEET a MIN oh fen and DYE fen HYE dra meen)
Brand Names: Anacin P.M. Aspirin Free, Coricidin Night Time Cold Relief, Excedrin PM, Excedrin PM Caplet, Headache Relief PM, Legatrin PM, Mapap PM, Midol PM, Percogesic Extra Strength, Tylenol Cold Relief Caplet, Tylenol Cold Relief Nighttime, Tylenol Cold Relief Nighttime Caplet, Tylenol Extra Strength PM, Tylenol Extra Strength PM Vanilla Caplet, Tylenol PM, Tylenol Severe Allergy Caplet, Tylenol Sore Throat Nighttime, Unisom with Pain Relief

What is Tylenol Severe Allergy Caplet (acetaminophen and diphenhydramine)?

Acetaminophen is a pain reliever and a fever reducer.

Diphenhydramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Diphenhydramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

The combination of acetaminophen and diphenhydramine is used to treat runny nose, sneezing, watery eyes, and pain or fever caused by allergies, the common cold, or the flu. This medication is also used to treat night time pain and help you sleep.

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

What is the most important information I should know about Tylenol Severe Allergy Caplet (acetaminophen and diphenhydramine)?

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 and cold medicines in very young children. 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, pain, 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”) or diphenhydramine. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen, and can add to drowsiness caused by an antihistamine. 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 Severe Allergy Caplet (acetaminophen and diphenhydramine)?

Do not take this medication if you are allergic to acetaminophen, diphenhydramine, or any antihistamine.

Before using acetaminophen and diphenhydramine, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;

• glaucoma;

• kidney disease;

• an enlarged prostate; or

• problems with urination.

Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

It is not known whether acetaminophen and diphenhydramine will harm an unborn baby. Before using acetaminophen, tell your doctor if you are pregnant. This medication may pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Tylenol Severe Allergy Caplet (acetaminophen and diphenhydramine)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

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. 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 dose of this medication may contain up to 1000 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. 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) of acetaminophen per day. Take this medicine with food or milk if it upsets your stomach.

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.

Store acetaminophen and diphenhydramine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

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

Overdose symptoms may include dizziness, drowsiness, feeling restless or nervous, dry mouth, warmth or tingly feeling, nausea, vomiting, diarrhea, stomach pain, loss of appetite, increased sweating, seizure (convulsions), or coma.

What should I avoid while taking Tylenol Severe Allergy Caplet (acetaminophen and diphenhydramine)?

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. Do not use any other cough, cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) and diphenhydramine are contained in many combination medicines. 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, APAP or diphenhydramine. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen, and can add to drowsiness caused by diphenhydramine.

Tylenol Severe Allergy Caplet (acetaminophen and diphenhydramine) 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 heartbeats;

• confusion, hallucinations, unusual thoughts or behavior;

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

• 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:

• dryness of the eyes, nose, and mouth;

• blurred vision;

• difficulty urinating;

• dizziness, drowsiness;

• problems with memory or concentration;

• ringing in your ears;

• feeling restless or excited (especially in children); or

• mild nausea, stomach pain, constipation.

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 Severe Allergy Caplet (acetaminophen and diphenhydramine)?

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by acetaminophen and diphenhydramine. Tell your doctor if you regularly use any of these other medicines.

The following drugs can interact with acetaminophen and diphenhydramine. Tell your doctor if you are using any of these:

• isoniazid;

• zidovudine (Retrovir, AZT);

• an antidepressant;

• a diuretic (water pill);

• gout medications such as probenecid (Benemid);

• medication to treat irritable bowel syndrome;

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

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

• seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

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

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen and diphenhydramine.

• 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: 9.01. Revision Date: 08/07/2009 9:15:45 AM.

Generic Name: Pseudoephedrine (soo-doe-e-FED-rin)
Brand Name: Examples include Children’s Sudafed and Unifed

Tylenol Simply Stuffy Liquid is used for:

Relieving congestion due to colds, flu, and allergies. It may also be used for other conditions as determined by your doctor.

Tylenol Simply Stuffy Liquid is a decongestant. It works by reducing swelling and constricting blood vessels in the nasal passages, allowing you to breathe more easily.

Do NOT use Tylenol Simply Stuffy Liquid if:

• you are allergic to any ingredient in Tylenol Simply Stuffy Liquid
• you are taking furazolidone or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the last 14 days
• you have severe high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tylenol Simply Stuffy Liquid:

Some medical conditions may interact with Tylenol Simply Stuffy Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of heart problems, diabetes, glaucoma, an enlarged prostate or other prostate problems, adrenal gland problems, high blood pressure, seizures, stroke, blood vessel problems, or an overactive thyroid

Some MEDICINES MAY INTERACT with Tylenol Simply Stuffy Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Rauwolfia derivatives (eg, reserpine) because the effectiveness of Tylenol Simply Stuffy Liquid may be decreased
• Beta-blockers (eg, propranolol), cocaine, furazolidone, indomethacin, methyldopa, MAO inhibitors (eg, phenelzine), oxytocic medicines (eg, oxytocin), rauwolfia derivatives (eg, reserpine), or tricyclic antidepressants (eg, amitriptyline) because the actions and side effects of Tylenol Simply Stuffy Liquid may be increased
• Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), digoxin, or droxidopa because the actions and side effects of these medicines may be increased
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because its effectiveness may be decreased by Tylenol Simply Stuffy Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol Simply Stuffy Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tylenol Simply Stuffy Liquid:

Use Tylenol Simply Stuffy Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Tylenol Simply Stuffy Liquid with food, water, or milk to minimize stomach irritation.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Tylenol Simply Stuffy Liquid and are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tylenol Simply Stuffy Liquid.

Important safety information:

• Tylenol Simply Stuffy Liquid may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tylenol Simply Stuffy Liquid. Using Tylenol Simply Stuffy Liquid alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• If your symptoms do not improve within 7 days or if you develop a high fever, check with your doctor.
• If you have trouble sleeping, ask your pharmacist or doctor about the best time to take Tylenol Simply Stuffy Liquid.
• Do not take diet or appetite control medicines while you are taking Tylenol Simply Stuffy Liquid.
• Tylenol Simply Stuffy Liquid contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
• Diabetes patients – Tylenol Simply Stuffy Liquid may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• Use Tylenol Simply Stuffy Liquid with caution in the ELDERLY because they may be more sensitive to its effects.
• Use Tylenol Simply Stuffy Liquid with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Tylenol Simply Stuffy Liquid during pregnancy. It is unknown if Tylenol Simply Stuffy Liquid is excreted in breast milk. If you are or will be breast-feeding while you are using Tylenol Simply Stuffy Liquid, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Tylenol Simply Stuffy Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Difficulty urinating; dizziness; headache; nausea; nervousness; restlessness; sleeplessness; stomach irritation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include confusion; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.

Proper storage of Tylenol Simply Stuffy Liquid:

Store Tylenol Simply Stuffy Liquid at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylenol Simply Stuffy Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Tylenol Simply Stuffy Liquid, please talk with your doctor, pharmacist, or other health care provider.
• Tylenol Simply Stuffy Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Tylenol Simply Stuffy Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Acetaminophen/Diphenhydramine/Pseudoephedrine (a-seet-a-MIN-oh-fen/dye-fen-HYE-dra-meen/sue-do-eh-FED-rin)
Brand Name: Examples include Benadryl Allergy/Cold and Tylenol Maximum Strength Flu Nighttime

Tylenol Maximum Strength Flu Nighttime is used for:

Relieving symptoms such as pain, sinus congestion, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also used for other conditions as determined by your doctor.

Tylenol Maximum Strength Flu Nighttime is an analgesic, antihistamine, and decongestant combination. The analgesic works in the brain to help decrease pain. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages, which decreases stuffiness.

Do NOT use Tylenol Maximum Strength Flu Nighttime if:

• you are allergic to any ingredient in Tylenol Maximum Strength Flu Nighttime
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
• you are unable to urinate or are having an asthma attack
• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tylenol Maximum Strength Flu Nighttime:

Some medical conditions may interact with Tylenol Maximum Strength Flu Nighttime. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a fast, slow, or irregular heartbeat
• if you have a history of asthma; lung problems (eg, chronic bronchitis, emphysema); adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; an overactive thyroid; or liver problems; or if you consume more than 3 alcohol-containing drinks per day

Some MEDICINES MAY INTERACT with Tylenol Maximum Strength Flu Nighttime. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone , indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Tylenol Maximum Strength Flu Nighttime may be increased
• Anticoagulants (eg, warfarin), digoxin, or droxidopa because risk of bleeding, irregular heartbeat, or heart attack may be increased
• Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Tylenol Maximum Strength Flu Nighttime
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Tylenol Maximum Strength Flu Nighttime

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol Maximum Strength Flu Nighttime may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tylenol Maximum Strength Flu Nighttime:

Use Tylenol Maximum Strength Flu Nighttime as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tylenol Maximum Strength Flu Nighttime may be taken with or without food.
• If you miss a dose of Tylenol Maximum Strength Flu Nighttime, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tylenol Maximum Strength Flu Nighttime.

Important safety information:

• Tylenol Maximum Strength Flu Nighttime may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tylenol Maximum Strength Flu Nighttime. Using Tylenol Maximum Strength Flu Nighttime alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Do not take diet or appetite control medicines while you are taking Tylenol Maximum Strength Flu Nighttime without checking with you doctor.
• Tylenol Maximum Strength Flu Nighttime contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
• Do NOT exceed the recommended dose or take Tylenol Maximum Strength Flu Nighttime for longer than prescribed without checking with your doctor.
• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
• Tylenol Maximum Strength Flu Nighttime may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Tylenol Maximum Strength Flu Nighttime. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• Tylenol Maximum Strength Flu Nighttime may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Tylenol Maximum Strength Flu Nighttime or other pain relievers/fever reducers. Alcohol use combined with Tylenol Maximum Strength Flu Nighttime may increase your risk for liver damage.
• If you are scheduled for allergy skin testing, do not take Tylenol Maximum Strength Flu Nighttime for several days before the test because it may decrease your response to the skin tests.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Tylenol Maximum Strength Flu Nighttime.
• Use Tylenol Maximum Strength Flu Nighttime with caution in the ELDERLY because they may be more sensitive to its effects.
• Caution is advised when using Tylenol Maximum Strength Flu Nighttime in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Tylenol Maximum Strength Flu Nighttime, discuss with your doctor the benefits and risks of using Tylenol Maximum Strength Flu Nighttime during pregnancy. It is unknown if Tylenol Maximum Strength Flu Nighttime is excreted in breast milk. Do not breast-feed while taking Tylenol Maximum Strength Flu Nighttime.

Possible side effects of Tylenol Maximum Strength Flu Nighttime:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mood or mental changes; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; tremor; trouble sleeping; vision changes; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Tylenol Maximum Strength Flu Nighttime:

Store Tylenol Maximum Strength Flu Nighttime at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylenol Maximum Strength Flu Nighttime out of the reach of children and away from pets.

General information:

• If you have any questions about Tylenol Maximum Strength Flu Nighttime, please talk with your doctor, pharmacist, or other health care provider.
• Tylenol Maximum Strength Flu Nighttime is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Tylenol Maximum Strength Flu Nighttime. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Acetaminophen/Dextromethorphan/Doxylamine/Pseudoephedrine (a-seet-a-MIN-oh-fen/dex-troe-meth-OR-fan/dox-IL-a-meen/sue-do-eh-FED-rin)
Brand Name: Examples include NyQuil and Tylenol NightTime Cold & Flu

Tylenol NightTime Cold & Flu Liquid is used for:

Relieving symptoms of pain, sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Tylenol NightTime Cold & Flu Liquid is a decongestant, antihistamine, cough suppressant, and analgesic combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms, such as watery eyes and sneezing. The analgesic and cough suppressant work in the brain to decrease pain and to reduce dry or unproductive cough.

Do NOT use Tylenol NightTime Cold & Flu Liquid if:

• you are allergic to any ingredient in Tylenol NightTime Cold & Flu Liquid
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
• you are unable to urinate or are having an asthma attack
• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tylenol NightTime Cold & Flu Liquid:

Some medical conditions may interact with Tylenol NightTime Cold & Flu Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a fast, slow, or irregular heartbeat
• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; an overactive thyroid; liver problems; or if you consume more than 3 alcohol-containing drinks per day
• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Tylenol NightTime Cold & Flu Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Tylenol NightTime Cold & Flu Liquid may be increased
• Anticoagulants (eg, warfarin), digoxin, or droxidopa because risk of bleeding, irregular heartbeat or heart attack may be increased
• Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Tylenol NightTime Cold & Flu Liquid
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Tylenol NightTime Cold & Flu Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol NightTime Cold & Flu Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tylenol NightTime Cold & Flu Liquid:

Use Tylenol NightTime Cold & Flu Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tylenol NightTime Cold & Flu Liquid may be taken with or without food.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Tylenol NightTime Cold & Flu Liquid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tylenol NightTime Cold & Flu Liquid.

Important safety information:

• Tylenol NightTime Cold & Flu Liquid may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tylenol NightTime Cold & Flu Liquid. Using Tylenol NightTime Cold & Flu Liquid alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Do not take diet or appetite control medicines while you are taking Tylenol NightTime Cold & Flu Liquid without checking with your doctor.
• Tylenol NightTime Cold & Flu Liquid contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
• Do NOT exceed the recommended dose or take Tylenol NightTime Cold & Flu Liquid for longer than prescribed without checking with your doctor.
• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
• Tylenol NightTime Cold & Flu Liquid may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Tylenol NightTime Cold & Flu Liquid. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• Tylenol NightTime Cold & Flu Liquid may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Tylenol NightTime Cold & Flu Liquid or other pain relievers/fever reducers. Alcohol use combined with Tylenol NightTime Cold & Flu Liquid may increase your risk for liver damage.
• If you are scheduled for allergy skin testing, do not take Tylenol NightTime Cold & Flu Liquid for several days before the test because it may decrease your response to the skin tests.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Tylenol NightTime Cold & Flu Liquid.
• Use Tylenol NightTime Cold & Flu Liquid with caution in the ELDERLY because they may be more sensitive to its effects.
• Caution is advised when using Tylenol NightTime Cold & Flu Liquid in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Tylenol NightTime Cold & Flu Liquid, discuss with your doctor the benefits and risks of using Tylenol NightTime Cold & Flu Liquid during pregnancy. It is unknown if Tylenol NightTime Cold & Flu Liquid is excreted in breast milk. Do not breast-feed while taking Tylenol NightTime Cold & Flu Liquid.

Possible side effects of Tylenol NightTime Cold & Flu Liquid:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; trouble sleeping; vision changes; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; and vomiting.

Proper storage of Tylenol NightTime Cold & Flu Liquid:

Store Tylenol NightTime Cold & Flu Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylenol NightTime Cold & Flu Liquid out of the reach of children and away from pets.

General information:

• If you have any questions about Tylenol NightTime Cold & Flu Liquid, please talk with your doctor, pharmacist, or other health care provider.
• Tylenol NightTime Cold & Flu Liquid is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Tylenol NightTime Cold & Flu Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: acetaminophen and diphenhydramine (a SEET a MIN oh fen and DYE fen HYE dra meen)
Brand Names: Anacin P.M. Aspirin Free, Coricidin Night Time Cold Relief, Excedrin PM, Excedrin PM Caplet, Headache Relief PM, Legatrin PM, Mapap PM, Midol PM, Percogesic Extra Strength, Tylenol Cold Relief Caplet, Tylenol Cold Relief Nighttime, Tylenol Cold Relief Nighttime Caplet, Tylenol Extra Strength PM, Tylenol Extra Strength PM Vanilla Caplet, Tylenol PM, Tylenol Severe Allergy Caplet, Tylenol Sore Throat Nighttime, Unisom with Pain Relief

What is Tylenol PM (acetaminophen and diphenhydramine)?

Acetaminophen is a pain reliever and a fever reducer.

Diphenhydramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Diphenhydramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

The combination of acetaminophen and diphenhydramine is used to treat runny nose, sneezing, watery eyes, and pain or fever caused by allergies, the common cold, or the flu. This medication is also used to treat night time pain and help you sleep.

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

What is the most important information I should know about Tylenol PM (acetaminophen and diphenhydramine)?

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 and cold medicines in very young children. 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, pain, 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”) or diphenhydramine. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen, and can add to drowsiness caused by an antihistamine. 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 PM (acetaminophen and diphenhydramine)?

Do not take this medication if you are allergic to acetaminophen, diphenhydramine, or any antihistamine.

Before using acetaminophen and diphenhydramine, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;

• glaucoma;

• kidney disease;

• an enlarged prostate; or

• problems with urination.

Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

It is not known whether acetaminophen and diphenhydramine will harm an unborn baby. Before using acetaminophen, tell your doctor if you are pregnant. This medication may pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Tylenol PM (acetaminophen and diphenhydramine)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

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. 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 dose of this medication may contain up to 1000 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. 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) of acetaminophen per day. Take this medicine with food or milk if it upsets your stomach.

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.

Store acetaminophen and diphenhydramine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

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

Overdose symptoms may include dizziness, drowsiness, feeling restless or nervous, dry mouth, warmth or tingly feeling, nausea, vomiting, diarrhea, stomach pain, loss of appetite, increased sweating, seizure (convulsions), or coma.

What should I avoid while taking Tylenol PM (acetaminophen and diphenhydramine)?

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. Do not use any other cough, cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) and diphenhydramine are contained in many combination medicines. 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, APAP or diphenhydramine. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen, and can add to drowsiness caused by diphenhydramine.

Tylenol PM (acetaminophen and diphenhydramine) 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 heartbeats;

• confusion, hallucinations, unusual thoughts or behavior;

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

• 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:

• dryness of the eyes, nose, and mouth;

• blurred vision;

• difficulty urinating;

• dizziness, drowsiness;

• problems with memory or concentration;

• ringing in your ears;

• feeling restless or excited (especially in children); or

• mild nausea, stomach pain, constipation.

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 PM (acetaminophen and diphenhydramine)?

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by acetaminophen and diphenhydramine. Tell your doctor if you regularly use any of these other medicines.

The following drugs can interact with acetaminophen and diphenhydramine. Tell your doctor if you are using any of these:

• isoniazid;

• zidovudine (Retrovir, AZT);

• an antidepressant;

• a diuretic (water pill);

• gout medications such as probenecid (Benemid);

• medication to treat irritable bowel syndrome;

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

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

• seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).

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

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen and diphenhydramine.

• 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: 9.01. Revision Date: 08/07/2009 9:15:45 AM.

Generic Name: Acetaminophen (a-seet-a-MIN-oh-fen)
Brand Name: Examples include Mapap Infants and Tylenol Infants

Tylenol Infants Suspension Drops are used for:

Treating minor aches and pains due to the common cold, flu, headaches, sore throat, immunizations, and toothaches, and for temporarily reducing fever.

Tylenol Infants Suspension Drops are an analgesic and antipyretic (lowers fever). It works by lowering a chemical in the brain that stimulates pain nerves and the heat-regulating center in the brain.

Do NOT use Tylenol Infants Suspension Drops if:

• you are allergic to any ingredient in Tylenol Infants Suspension Drops

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tylenol Infants Suspension Drops:

Some medical conditions may interact with Tylenol Infants Suspension Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of alcohol abuse or if you drink 3 or more alcohol-containing drinks every day
• if you have liver or kidney problems or hepatitis

Some MEDICINES MAY INTERACT with Tylenol Infants Suspension Drops. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Isoniazid because the risk of liver problems may be increased
• Anticoagulants (eg, warfarin) because the risk of their side effects, including bleeding, may be increased by Tylenol Infants Suspension Drops

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol Infants Suspension Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tylenol Infants Suspension Drops:

Use Tylenol Infants Suspension Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Tylenol Infants Suspension Drops by mouth with or without food.
• Shake well before each use.
• Find the right dose on chart that comes with Tylenol Infants Suspension Drops. If possible, use weight to dose; otherwise use age.
• Use the dropper that comes with Tylenol Infants Suspension Drops to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Replace original bottle cap to maintain child resistance.
• If you miss a dose of Tylenol Infants Suspension Drops and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tylenol Infants Suspension Drops.

Important safety information:

• Tylenol Infants Suspension Drops has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Tylenol Infants Suspension Drops may harm your liver. Your risk may be greater if you drink alcohol while you are using Tylenol Infants Suspension Drops. Talk to your doctor before you take Tylenol Infants Suspension Drops or other fever reducers if you drink more than 3 drinks with alcohol per day.
• Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use for more than 2 days or give to children younger than 3 years old unless directed by a doctor.
• Tylenol Infants Suspension Drops may cause the results of some in-home test kits for blood cholesterol to be wrong. Check with your doctor or pharmacist if you are taking Tylenol Infants Suspension Drops and need to check your blood cholesterol at home.
• For pain and fever in ADULTS: Stop use of Tylenol Infants Suspension Drops and ask your doctor if pain gets worse or lasts more than 10 days, fever gets worse or lasts more than 3 days, or new symptoms occur or redness or swelling is present.
• For pain and fever in CHILDREN: Stop use and ask a doctor if fever gets worse or lasts more than 3 days, pain gets worse or lasts more than 5 days, or redness or swelling is present or any new symptoms appear.
• Different brands of Tylenol Infants Suspension Drops may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tylenol Infants Suspension Drops while you are pregnant. Tylenol Infants Suspension Drops are found in breast milk. If you are or will be breast-feeding while you use Tylenol Infants Suspension Drops, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Tylenol Infants Suspension Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine or pale stools; unusual fatigue; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include dark urine; excessive sweating; extreme fatigue; nausea and vomiting; stomach pain.

Proper storage of Tylenol Infants Suspension Drops:

Store Tylenol Infants Suspension Drops at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylenol Infants Suspension Drops out of the reach of children and away from pets.

General information:

• If you have any questions about Tylenol Infants Suspension Drops, please talk with your doctor, pharmacist, or other health care provider.
• Tylenol Infants Suspension Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Tylenol Infants Suspension Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.