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Tylophen

30/06/10

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

Tylophen is used for:

Treating minor aches and pains due to headache, muscle aches, backache, arthritis, the common cold, flu, toothache, menstrual cramps, and immunizations, and for temporarily reducing fever.

Tylophen is 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 Tylophen if:

you are allergic to any ingredient in Tylophen

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

Before using Tylophen:

Some medical conditions may interact with Tylophen. 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 you drink more than 3 alcohol-containing drinks every day
if you have liver or kidney problems, hepatitis, or phenylketonuria (PKU)

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

Anticoagulants (eg, warfarin) because the risk of their side effects, including bleeding, may be increased by Tylophen
Isoniazid because the risk of liver problems may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylophen 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 Tylophen:

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

Take Tylophen by mouth with or without food.
Replace original bottle cap to maintain child resistance.
If you miss a dose of Tylophen 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 Tylophen.

Important safety information:

Tylophen 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.
Tylophen may harm your liver. Your risk may be greater if you drink alcohol while you are using Tylophen. Talk to your doctor before you take Tylophen 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.
Tylophen 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 Tylophen and need to check your blood cholesterol at home.
For pain and fever in ADULTS: Stop use of Tylophen 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.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tylophen while you are pregnant. Tylophen is found in breast milk. If you are or will be breast-feeding while you use Tylophen, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Tylophen:

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:

Proper storage of Tylophen:

Store Tylophen 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 Tylophen out of the reach of children and away from pets.

General information:

If you have any questions about Tylophen, please talk with your doctor, pharmacist, or other health care provider.
Tylophen 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 Tylophen. 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.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,T

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Tylox

30/06/10

Generic Name: acetaminophen and oxycodone (a SEET a MIN oh fen and OX i KOE done)
Brand Names: Endocet, Magnacet, Percocet 10/325, Percocet 10/650, Percocet 2.5/325, Percocet 5/325, Percocet 7.5/325, Percocet 7.5/500, Perloxx, Primalev, Roxicet, Tylox, Xolox

What is acetaminophen and oxycodone?

Oxycodone is in a group of drugs called narcotic pain relievers. Acetaminophen is a less potent pain reliever that increases the effects of oxycodone.

The combination of acetaminophen and oxycodone is used to relieve moderate to severe pain.

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

What is the most important information I should know about acetaminophen and oxycodone?

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

Oxycodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. 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.

What should I discuss with my healthcare provider before taking acetaminophen and oxycodone?

Do not use this medication if you are allergic to acetaminophen (Tylenol) or oxycodone. Oxycodone may be habit-forming and should be used only by the person it was prescribed for. Acetaminophen and oxycodone should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take acetaminophen and oxycodone, tell your doctor if you are allergic to any drugs, or if you have:

asthma, COPD, sleep apnea, or other breathing disorders;
liver or kidney disease;
a history of head injury or brain tumor;
epilepsy or other seizure disorder;
low blood pressure;
a stomach, intestinal, or pancreas disorder;
underactive thyroid;
Addison’s disease or other adrenal gland disorder;
enlarged prostate, urination problems;
curvature of the spine;
mental illness; or
a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Before you take acetaminophen and oxycodone, tell your doctor if you are pregnant or plan to become pregnant during treatment. Acetaminophen and oxycodone 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.

How should I take acetaminophen and oxycodone?

Take this medication exactly as it was prescribed for you. Do not take it in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

An overdose of acetaminophen can cause serious harm to your liver. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. One acetaminophen and oxycodone tablet may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Measure the liquid form of this medication 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 where you can get one.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and oxycodone. Do not use a stool softener (laxative) without first asking your doctor. You may have withdrawal symptoms when you stop using acetaminophen and oxycodone after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

This medication can cause you to have unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen and oxycodone.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using acetaminophen and oxycodone. You may need to stop using the medicine for a short time.

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

Keep track of how many tablets have been used from each new bottle of this medicine. Oxycodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Since acetaminophen and oxycodone is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use 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. An overdose of acetaminophen and oxycodone can be fatal.

Overdose symptoms may include extreme drowsiness, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, cold and clammy skin, muscle weakness, fainting, weak pulse, coma, blue lips, shallow breathing, or no breathing.

What should I avoid while taking acetaminophen and oxycodone?

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 cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP. Avoid drinking alcohol while taking acetaminophen and oxycodone. Alcohol may increase your risk of liver damage while taking acetaminophen.

Acetaminophen and oxycodone 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. Call your doctor at once if you have any of these serious side effects:

shallow breathing, slow heartbeat;
feeling light-headed, fainting;
confusion, unusual thoughts or behavior;
seizure (convulsions); or
nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

feeling dizzy or drowsy;
mild nausea, vomiting, upset stomach, constipation;
blurred vision; or
dry mouth.

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 acetaminophen and oxycodone?

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

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

glycopyrrolate (Robinul);
mepenzolate (Cantil);
atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

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

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.

Concise,T

Comments (0)

Tylenol with Codeine #3

30/06/10

Generic Name: acetaminophen and codeine (a SEET a MIN o fen and KOE deen)
Brand Names: Capital with Codeine Suspension, Cocet, EZ III, Tylenol with Codeine #3, Tylenol with Codeine #4, Vopac

What is Tylenol with Codeine #3 (acetaminophen and codeine)?

Codeine is in a group of drugs called narcotic pain relievers. Acetaminophen is a less potent pain reliever that increases the effects of codeine.

The combination of acetaminophen and codeine is used to relieve moderate to severe pain.

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

What is the most important information I should know about Tylenol with Codeine #3 (acetaminophen and codeine)?

An overdose of acetaminophen can damage your liver. Adults should not take more than 1 gram (1000 mg) of acetaminophen per dose or 4 grams (4000 mg) per day. If you drink more than three alcoholic beverages per day, you should never use more than 2 grams (2000 mg) of acetaminophen per day. Ask a doctor or pharmacist before using any cold, allergy, pain, or sleep medicine. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen. Check the label to see if a medicine contains acetaminophen or APAP. Codeine may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Acetaminophen and codeine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What should I discuss with my healthcare provider before taking Tylenol with Codeine #3 (acetaminophen and codeine)?

Do not use this medication if you are allergic to acetaminophen (Tylenol) or codeine. Codeine may be habit-forming and should be used only by the person it was prescribed for. Never share acetaminophen and codine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

If you have any of these other conditions, you may need a dose adjustment or special tests:

asthma, COPD, sleep apnea, or other breathing disorders;
liver or kidney disease;
a history of head injury or brain tumor;
epilepsy or other seizure disorder;
low blood pressure;
a stomach or intestinal disorder;
underactive thyroid;
Addison’s disease or other adrenal gland disorder;
enlarged prostate, urination problems;
curvature of the spine;
mental illness; or
a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. Acetaminophen and codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Tylenol with Codeine #3 (acetaminophen and codeine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

One acetaminophen and codeine tablet may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Take this medicine with food or milk to ease stomach upset.

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

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and codeine. Do not use a stool softener (laxative) without first asking your doctor. Do not stop using acetaminophen and codeine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using acetaminophen and codeine.

This medication can cause unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen and codeine.

If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and codeine. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medication is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and codeine can be fatal.

Overdose symptoms may include extreme drowsiness, sweating, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, cold and clammy skin, fainting, weak pulse, seizure (convulsions), coma, blue lips, shallow breathing, or no breathing.

What should I avoid while taking Tylenol with Codeine #3 (acetaminophen and codeine)?

Acetaminophen and codeine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage.

Tylenol with Codeine #3 (acetaminophen and codeine) side effects

shallow breathing, slow heartbeat;
feeling light-headed, fainting;
confusion, unusual thoughts or behavior;
seizure (convulsions);
easy bruising or bleeding; or
nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

feeling dizzy or drowsy;
mild nausea, vomiting, upset stomach, constipation;
headache;
blurred vision; or
dry mouth.

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 with Codeine #3 (acetaminophen and codeine)?

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

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

glycopyrrolate (Robinul);
mepenzolate (Cantil);
atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
a bronchodilator such as ipratroprium (Atrovent) or tiotropium (Spiriva); or
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and other drugs may interact with acetaminophen and codeine. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. 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 codeine.

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.

Concise,T

Comments (0)

Tylenol with Codeine #4

30/06/10

Generic Name: acetaminophen and codeine (a SEET a MIN o fen and KOE deen)
Brand Names: Capital with Codeine Suspension, Cocet, EZ III, Tylenol with Codeine #3, Tylenol with Codeine #4, Vopac

What is Tylenol with Codeine #4 (acetaminophen and codeine)?

Codeine is in a group of drugs called narcotic pain relievers. Acetaminophen is a less potent pain reliever that increases the effects of codeine.

The combination of acetaminophen and codeine is used to relieve moderate to severe pain.

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

What is the most important information I should know about Tylenol with Codeine #4 (acetaminophen and codeine)?

What should I discuss with my healthcare provider before taking Tylenol with Codeine #4 (acetaminophen and codeine)?

If you have any of these other conditions, you may need a dose adjustment or special tests:

asthma, COPD, sleep apnea, or other breathing disorders;
liver or kidney disease;
a history of head injury or brain tumor;
epilepsy or other seizure disorder;
low blood pressure;
a stomach or intestinal disorder;
underactive thyroid;
Addison’s disease or other adrenal gland disorder;
enlarged prostate, urination problems;
curvature of the spine;
mental illness; or
a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. Acetaminophen and codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Tylenol with Codeine #4 (acetaminophen and codeine)?

One acetaminophen and codeine tablet may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Take this medicine with food or milk to ease stomach upset.

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

This medication can cause unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen and codeine.

If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and codeine. You may need to stop using the medicine for a short time.

What happens if I miss a dose?

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and codeine can be fatal.

What should I avoid while taking Tylenol with Codeine #4 (acetaminophen and codeine)?

Tylenol with Codeine #4 (acetaminophen and codeine) side effects

shallow breathing, slow heartbeat;
feeling light-headed, fainting;
confusion, unusual thoughts or behavior;
seizure (convulsions);
easy bruising or bleeding; or
nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

feeling dizzy or drowsy;
mild nausea, vomiting, upset stomach, constipation;
headache;
blurred vision; or
dry mouth.

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 with Codeine #4 (acetaminophen and codeine)?

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

glycopyrrolate (Robinul);
mepenzolate (Cantil);
atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
a bronchodilator such as ipratroprium (Atrovent) or tiotropium (Spiriva); or
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

Where can I get more information?

Your pharmacist can provide more information about acetaminophen and codeine.

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.

Concise,T

Comments (0)

Tylenol w/Codeine #4

30/06/10

Generic Name: acetaminophen and codeine (Oral route)

a-seet-a-MIN-oh-fen, KOE-deen FOS-fate

Commonly used brand name(s):

In the U.S.

APAP w/Codeine
Capital w/Codeine
Pyregesic-C
Tylenol w/Codeine
Tylenol w/Codeine #3
Tylenol w/Codeine #4
Tylenol with Codeine No. 3
Vopac

Available Dosage Forms:

Tablet
Capsule
Elixir
Suspension
Solution

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Codeine

Uses For Tylenol w/Codeine #4

Acetaminophen and codeine oral suspension is used to relieve mild to moderate pain. The oral tablets are used to relieve mild to moderately severe pain.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

Codeine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When codeine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor’s prescription.

Before Using Tylenol w/Codeine #4

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of acetaminophen and codeine oral suspension in children younger than 3 years of age. Safety and efficacy have not been established.

No information is available on the relationship of age to the effects of acetaminophen and codeine tablets in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of acetaminophen and codeine combination in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Naltrexone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Adinazolam
Alfentanil
Alprazolam
Amobarbital
Anileridine
Aprobarbital
Bromazepam
Brotizolam
Buprenorphine
Butabarbital
Butalbital
Butorphanol
Carisoprodol
Chloral Hydrate
Chlordiazepoxide
Chlorzoxazone
Clobazam
Clonazepam
Clorazepate
Codeine
Dantrolene
Dezocine
Diazepam
Estazolam
Ethchlorvynol
Fentanyl
Flunitrazepam
Flurazepam
Halazepam
Hydrocodone
Hydromorphone
Ketazolam
Levorphanol
Lorazepam
Lormetazepam
Medazepam
Meperidine
Mephenesin
Mephobarbital
Meprobamate
Metaxalone
Methocarbamol
Methohexital
Midazolam
Morphine
Morphine Sulfate Liposome
Nalbuphine
Nitrazepam
Nordazepam
Opium
Oxazepam
Oxycodone
Oxymorphone
Pentazocine
Pentobarbital
Phenobarbital
Prazepam
Propoxyphene
Quazepam
Remifentanil
Secobarbital
Sodium Oxybate
Sufentanil
Tapentadol
Temazepam
Thiopental
Triazolam

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol
Carbamazepine
Isoniazid
Phenytoin
Warfarin
Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Cabbage
Ethanol

Proper Use of acetaminophen and codeine

This section provides information on the proper use of a number of products that contain acetaminophen and codeine. It may not be specific to Tylenol w/Codeine #4. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Large amounts of acetaminophen may cause liver damage.

Shake the oral suspension well before each use. Measure the medicine with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (suspension):
- For mild to moderate pain:
  - Adults—15 milliliters (mL) or 1 tablespoonful every 4 hours as needed.
  - Children 7 to 12 years of age—10 mL (2 teaspoonfuls) 3 or 4 times per day.
  - Children 3 to 6 years of age—5 mL (1 teaspoonful) 3 or 4 times per day.
  - Children younger than 3 years of age—Use and dose must be determined by your doctor.
For oral dosage form (tablets):
- For mild to moderately severe pain:
  - Adults—15 to 60 milligrams (mg) of codeine and 300 to 1000 mg of acetaminophen every 4 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 360 mg of codeine and 4000 mg of acetaminophen per 24 hours.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Tylenol w/Codeine #4

It is very important that your doctor check the progress of you or your child while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

For patients taking a codeine-containing medicine or any other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine):

Contact your doctor right away if you have extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an “ultra-rapid metabolizer of codeine”. Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your child has the following symptoms: abnormal sleep pattern, diarrhea, high-pitched cry, irritability, shakiness or tremor, weight loss, vomiting, or failure to gain weight.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of certain tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Tylenol w/Codeine #4 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Difficult or troubled breathing
irregular, fast or slow, or shallow breathing
pale or blue lips, fingernails, or skin
shortness of breath

Incidence not known

Black, tarry stools
bleeding gums
blood in the urine or stools
cough or hoarseness
difficulty with swallowing
dizziness
fast heartbeat
fever with or without chills
general feeling of tiredness or weakness
hives
itching
lower back or side pain
painful or difficult urination
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
skin rash
sore throat
sores, ulcers, or white spots on the lips or in the mouth
tightness in the chest
unusual bleeding or bruising
unusual tiredness or weakness
wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Abdominal or stomach pain
bloody or cloudy urine
chills
constricted, pinpoint, or small pupils (black part of the eye)
convulsion
dark urine
headache
increased sweating
light-colored stools
loss of appetite
loss of consciousness
nausea
sudden decrease in the amount of urine
unpleasant breath odor
vomiting
vomiting of blood
yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Drowsiness
lightheadedness
relaxed and calm
sleepiness

Incidence not known

Difficulty having a bowel movement (stool)
false or unusual sense of well-being

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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Tylenol with Codeine

30/06/10

Generic name: Acetaminophen, Codeine phosphate
Brand names: Tylenol with Codeine, Phenaphen with Codeine

Why is Tylenol with Codeine prescribed?

Tylenol with Codeine, a narcotic analgesic, is used to treat mild to moderately severe pain. It contains two drugs–acetaminophen and codeine. Acetaminophen, an antipyretic (fever-reducing) analgesic, is used to reduce pain and fever. Codeine, a narcotic analgesic, is used to treat pain that is moderate to severe.

People who are allergic to aspirin can take Tylenol with Codeine.

Most important fact about Tylenol with Codeine

Tylenol with Codeine contains a narcotic (codeine) and, even if taken in prescribed amounts, can cause physical and psychological addiction if taken for a long enough time.

Addiction may be more of a risk for a person who has been addicted to alcohol or drugs. Be sure to follow your doctor’s instructions carefully when taking Tylenol with Codeine (or any other drugs that contain a narcotic).

How should you take Tylenol with Codeine?

Tylenol with Codeine may be taken with meals or with milk (but not with alcohol).

–If you miss a dose…

If you take Tylenol with Codeine on a regular schedule, take the forgotten dose as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once.

–Storage instructions…

Store away from heat, light, and moisture. Keep the liquid from freezing.

Tylenol with Codeine side effects

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Tylenol with Codeine.

Side effects may include:
Dizziness, light-headedness, nausea, sedation, shortness of breath, vomiting

Why should Tylenol with Codeine not be prescribed?

You should not use Tylenol with Codeine if you are sensitive to either acetaminophen or codeine.

Special warnings about Tylenol with Codeine

You should take Tylenol with Codeine cautiously and only according to your doctor’s instructions, as you would take any medication containing a narcotic. Make sure your doctor is aware of any problems you have had with drug or alcohol addiction.

Tylenol with Codeine tablets contain a sulfite that may cause allergic reactions in some people. These reactions may include shock and severe, possibly life-threatening, asthma attacks. People with asthma are more likely to be sensitive to sulfites.

If you have experienced a head injury, consult your doctor before taking Tylenol with Codeine.

If you have stomach problems, such as an ulcer, check with your doctor before taking Tylenol with Codeine. Tylenol with Codeine may obscure the symptoms of stomach problems, making them difficult to diagnose and treat.

If you have ever had liver, kidney, thyroid, or adrenal disease, difficulty urinating, or an enlarged prostate, consult your doctor before taking Tylenol with Codeine.

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

This drug may cause drowsiness and impair your ability to drive a car or operate potentially dangerous machinery. Do not participate in any activities that require full attention when using Tylenol with Codeine until you are sure of its effect on you.

Possible food and drug interactions when taking Tylenol with Codeine

Alcohol may increase the sedative effects of Tylenol with Codeine. Therefore, do not drink alcohol while you are taking Tylenol with Codeine.

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

Antidepressants such as Elavil, Nardil, Parnate, and Tofranil
Drugs that control spasms, such as Cogentin
Major tranquilizers such as Clozaril and Thorazine
Other narcotic painkillers such as Darvon
Tranquilizers such as Xanax and Valium

Special information if you are pregnant or breastfeeding

It is not known if Tylenol with Codeine could injure a baby, or if it could affect a woman’s reproductive capacity. Using any medication that contains a narcotic during pregnancy may cause babies to be born with a physical addiction to the narcotic. If you are pregnant or plan to become pregnant, you should not take Tylenol with Codeine unless the potential benefits clearly outweigh the possible dangers. As with other narcotic painkillers, taking Tylenol with Codeine shortly before delivery (especially at higher dosages) may cause some degree of breathing difficulty in the mother and newborn.

Some studies (but not all) have reported that codeine appears in breast milk and may affect a nursing infant. Therefore, nursing mothers should use Tylenol with Codeine only if the potential gains are greater than the potential hazards.

Recommended dosage for Tylenol with Codeine

ADULTS

Dosage will depend on how severe your pain is and how you respond to the drug.

To Relieve Pain

A single dose may contain from 15 milligrams to 60 milligrams of codeine phosphate and from 300 to 1,000 milligrams of acetaminophen. The maximum dose in a 24-hour period should be 360 milligrams of codeine phosphate and 4,000 milligrams of acetaminophen. Your doctor will determine the amounts of codeine phosphate and acetaminophen taken in each dose. Doses may be repeated up to every 4 hours.

Single doses above 60 milligrams of codeine do not give enough pain relief to balance the increased number of side effects.

Adults may also take Tylenol with Codeine elixir (liquid). Tylenol with Codeine elixir contains 120 milligrams of acetaminophen and 12 milligrams of codeine phosphate per teaspoonful.

The usual adult dose is 1 tablespoonful every 4 hours as needed.

CHILDREN

The safety of Tylenol with Codeine elixir has not been established in children under 3 years old.

Children 3 to 6 years old may take 1 teaspoonful 3 or 4 times daily.

Children 7 to 12 years old may take 2 teaspoonsful 3 or 4 times daily.

OLDER ADULTS

Older people and anyone in a weakened or rundown condition should use Tylenol with Codeine cautiously.

Overdosage

Any medication taken in excess can cause symptoms of overdose. Severe overdosage of Tylenol with Codeine can cause death. If you suspect an overdose, seek medical attention immediately.

Symptoms of Tylenol with Codeine overdose may include:
Bluish skin, cold and clammy skin, coma due to low blood sugar, decreased, irregular, or stopped breathing, extreme sleepiness progressing to stupor or coma, general bodily discomfort, heart attack, kidney failure, liver failure, low blood pressure, muscle weakness, nausea, slow heartbeat, sweating, vomiting

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Tylenol Sore Throat Nighttime

30/06/10

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 Sore Throat Nighttime (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 Sore Throat Nighttime (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 Sore Throat Nighttime (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 Sore Throat Nighttime (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 Sore Throat Nighttime (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 Sore Throat Nighttime (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 Sore Throat Nighttime (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.

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30/06/10

Tylenol w/

Codeine

Generic Name: Acetaminophen/Codeine (a-seet-a-MIN-oh-fen/KOE-deen)
Brand Name: Examples include Aceta w/ Codeine and Tylenol w/ Codeine

Tylenol w/ Codeine is used for:

Relieving mild to moderate pain. It may also be used for other conditions as determined by your doctor.

Tylenol w/ Codeine is an analgesic combination. It works in certain areas of the brain and nervous system to decrease pain. The combination may provide better pain relief than either medicine alone.

Do NOT use Tylenol w/ Codeine if:

you are allergic to any ingredient in Tylenol w/ Codeine or any other codeine- or morphine-related medicine (eg, oxycodone)
you have severe diarrhea due to taking an antibiotic
you are taking naltrexone, quinidine, or sodium oxybate (GHB)

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

Before using Tylenol w/ Codeine:

Some medical conditions may interact with Tylenol w/ Codeine. 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 alcoholism or substance abuse, or you consume more than 3 alcoholic drinks per day
if you have considered or attempted suicide
if you have recently had any head injury, brain injury or tumor, increased pressure in the brain, or an infection of the brain or nervous system
if you have asthma, other lung or breathing problems, epilepsy, or seizures
if you have a history of stomach or intestinal problems, chronic inflammation or ulceration of the bowel, or gallbladder problems (eg, gallstones), or you have had recent abdominal surgery
if you have Addison disease, heart problems, liver problems (eg, hepatitis), an underactive thyroid, prostate problems, severe kidney problems, or urinary problems

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

Naltrexone because it may decrease the effectiveness of Tylenol w/ Codeine and withdrawal symptoms may occur if you are physically dependent on opioids. You must not take naltrexone until you have stopped taking Tylenol w/ Codeine for 7 to 10 days and after a naloxone challenge test is negative.
Quinidine because it may decrease the effectiveness of Tylenol w/ Codeine
Cimetidine, ethanol, HIV protease inhibitors (eg, ritonavir), isoniazid, medicine for mental or mood disorders (eg, olanzapine, haloperidol), medicine for anxiety (eg, diazepam), other narcotic pain medicine (eg, oxycodone), or sodium oxybate (GHB) because side effects such as excessive drowsiness, disorientation, trouble breathing, or seizures may occur
Anticoagulants (eg, warfarin) because the risk of side effects such as bleeding may be increased by Tylenol w/ Codeine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol w/ Codeine 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 w/ Codeine:

Use Tylenol w/ Codeine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Tylenol w/ Codeine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation..
If you miss a dose of Tylenol w/ Codeine 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 w/ Codeine.

Important safety information:

Tylenol w/ Codeine may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Tylenol w/ Codeine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Tylenol w/ Codeine may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tylenol w/ Codeine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Tylenol w/ Codeine may harm your liver. Your risk may be greater if you drink alcohol while you are using Tylenol w/ Codeine. Talk to your doctor before you take Tylenol w/ Codeine or other fever reducers if you drink more than 3 drinks with alcohol per day.
Do not take more than the recommended dose or use Tylenol w/ Codeine for longer than prescribed without checking with your doctor. Do not suddenly stop taking Tylenol w/ Codeine without first checking with your doctor.
Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.
Tylenol w/ Codeine 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 w/ Codeine may cause constipation. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while taking Tylenol w/ Codeine, talk with your doctor or pharmacist. A stool softener or fiber laxative may be required.
If nausea occurs, consult your doctor or pharmacist about alternatives for decreasing nausea (eg, taking antihistamines, lying down for 1 to 2 hours with minimal head movement).
Use Tylenol w/ Codeine with caution in the ELDERLY; they may be more sensitive to its effect, especially drowsiness and trouble breathing.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tylenol w/ Codeine while you are pregnant. Tylenol w/ Codeine is found in breast milk. If you are or will be breast-feeding while you use Tylenol w/ Codeine, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Tylenol w/ Codeine may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Tylenol w/ Codeine stops working well. Do not take more than prescribed.

Some people who use Tylenol w/ Codeine for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Tylenol w/ Codeine, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Tylenol w/ Codeine:

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:

Blurred vision; constipation; dizziness; drowsiness; exaggerated sense of well-being; feeling unwell or unhappy; flushing; lightheadedness; mental/mood changes; nausea; stomach pain; vision changes; vomiting.

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); change in the amount of urine; dark urine; difficulty breathing; slow/irregular breathing; slow/irregular heartbeat; stomach pain; yellowing of the skin or eyes.

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 cold, clammy skin; extreme drowsiness; fatigue; loss of consciousness; persistent nausea/vomiting; slow heartbeat; slow, shallow, or abnormal breathing; stomach pain; unusual sweating; weakness; yellowing of the skin or eyes.

Proper storage of Tylenol w/ Codeine:

Store Tylenol w/ Codeine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylenol w/ Codeine out of the reach of children and away from pets.

General information:

If you have any questions about Tylenol w/ Codeine, please talk with your doctor, pharmacist, or other health care provider.
Tylenol w/ Codeine 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 w/ Codeine. 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.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,T

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Tylenol w/Codeine

30/06/10

Generic Name: acetaminophen and codeine (Oral route)

a-seet-a-MIN-oh-fen, KOE-deen FOS-fate

Commonly used brand name(s):

In the U.S.

APAP w/Codeine
Capital w/Codeine
Pyregesic-C
Tylenol w/Codeine
Tylenol w/Codeine #3
Tylenol w/Codeine #4
Tylenol with Codeine No. 3
Vopac

Available Dosage Forms:

Tablet
Capsule
Elixir
Suspension
Solution

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Codeine

Uses For Tylenol w/Codeine

Acetaminophen and codeine oral suspension is used to relieve mild to moderate pain. The oral tablets are used to relieve mild to moderately severe pain.

Codeine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

This medicine is available only with your doctor’s prescription.

Before Using Tylenol w/Codeine

Allergies

Pediatric

No information is available on the relationship of age to the effects of acetaminophen and codeine tablets in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of acetaminophen and codeine combination in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Naltrexone

Adinazolam
Alfentanil
Alprazolam
Amobarbital
Anileridine
Aprobarbital
Bromazepam
Brotizolam
Buprenorphine
Butabarbital
Butalbital
Butorphanol
Carisoprodol
Chloral Hydrate
Chlordiazepoxide
Chlorzoxazone
Clobazam
Clonazepam
Clorazepate
Codeine
Dantrolene
Dezocine
Diazepam
Estazolam
Ethchlorvynol
Fentanyl
Flunitrazepam
Flurazepam
Halazepam
Hydrocodone
Hydromorphone
Ketazolam
Levorphanol
Lorazepam
Lormetazepam
Medazepam
Meperidine
Mephenesin
Mephobarbital
Meprobamate
Metaxalone
Methocarbamol
Methohexital
Midazolam
Morphine
Morphine Sulfate Liposome
Nalbuphine
Nitrazepam
Nordazepam
Opium
Oxazepam
Oxycodone
Oxymorphone
Pentazocine
Pentobarbital
Phenobarbital
Prazepam
Propoxyphene
Quazepam
Remifentanil
Secobarbital
Sodium Oxybate
Sufentanil
Tapentadol
Temazepam
Thiopental
Triazolam

Acenocoumarol
Carbamazepine
Isoniazid
Phenytoin
Warfarin
Zidovudine

Interactions with Food/Tobacco/Alcohol

Ethanol

Cabbage
Ethanol

Proper Use of acetaminophen and codeine

This section provides information on the proper use of a number of products that contain acetaminophen and codeine. It may not be specific to Tylenol w/Codeine. Please read with care.

Dosing

For oral dosage form (suspension):
- For mild to moderate pain:
  - Adults—15 milliliters (mL) or 1 tablespoonful every 4 hours as needed.
  - Children 7 to 12 years of age—10 mL (2 teaspoonfuls) 3 or 4 times per day.
  - Children 3 to 6 years of age—5 mL (1 teaspoonful) 3 or 4 times per day.
  - Children younger than 3 years of age—Use and dose must be determined by your doctor.
For oral dosage form (tablets):
- For mild to moderately severe pain:
  - Adults—15 to 60 milligrams (mg) of codeine and 300 to 1000 mg of acetaminophen every 4 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 360 mg of codeine and 4000 mg of acetaminophen per 24 hours.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Tylenol w/Codeine

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

For patients taking a codeine-containing medicine or any other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine):

Contact your doctor right away if you have extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an “ultra-rapid metabolizer of codeine”. Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of certain tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Tylenol w/Codeine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Difficult or troubled breathing
irregular, fast or slow, or shallow breathing
pale or blue lips, fingernails, or skin
shortness of breath

Incidence not known

Black, tarry stools
bleeding gums
blood in the urine or stools
cough or hoarseness
difficulty with swallowing
dizziness
fast heartbeat
fever with or without chills
general feeling of tiredness or weakness
hives
itching
lower back or side pain
painful or difficult urination
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
skin rash
sore throat
sores, ulcers, or white spots on the lips or in the mouth
tightness in the chest
unusual bleeding or bruising
unusual tiredness or weakness
wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Abdominal or stomach pain
bloody or cloudy urine
chills
constricted, pinpoint, or small pupils (black part of the eye)
convulsion
dark urine
headache
increased sweating
light-colored stools
loss of appetite
loss of consciousness
nausea
sudden decrease in the amount of urine
unpleasant breath odor
vomiting
vomiting of blood
yellow eyes or skin

More common

Drowsiness
lightheadedness
relaxed and calm
sleepiness

Incidence not known

Difficulty having a bowel movement (stool)
false or unusual sense of well-being

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Advanced,T

Comments (0)

Tylenol w/Codeine #3

30/06/10

Generic Name: acetaminophen and codeine (Oral route)

a-seet-a-MIN-oh-fen, KOE-deen FOS-fate

Commonly used brand name(s):

In the U.S.

APAP w/Codeine
Capital w/Codeine
Pyregesic-C
Tylenol w/Codeine
Tylenol w/Codeine #3
Tylenol w/Codeine #4
Tylenol with Codeine No. 3
Vopac

Available Dosage Forms:

Tablet
Capsule
Elixir
Suspension
Solution

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Codeine

Uses For Tylenol w/Codeine #3

Acetaminophen and codeine oral suspension is used to relieve mild to moderate pain. The oral tablets are used to relieve mild to moderately severe pain.

Codeine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

This medicine is available only with your doctor’s prescription.

Before Using Tylenol w/Codeine #3

Allergies

Pediatric

No information is available on the relationship of age to the effects of acetaminophen and codeine tablets in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of acetaminophen and codeine combination in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Interactions with Medicines

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Naltrexone

Adinazolam
Alfentanil
Alprazolam
Amobarbital
Anileridine
Aprobarbital
Bromazepam
Brotizolam
Buprenorphine
Butabarbital
Butalbital
Butorphanol
Carisoprodol
Chloral Hydrate
Chlordiazepoxide
Chlorzoxazone
Clobazam
Clonazepam
Clorazepate
Codeine
Dantrolene
Dezocine
Diazepam
Estazolam
Ethchlorvynol
Fentanyl
Flunitrazepam
Flurazepam
Halazepam
Hydrocodone
Hydromorphone
Ketazolam
Levorphanol
Lorazepam
Lormetazepam
Medazepam
Meperidine
Mephenesin
Mephobarbital
Meprobamate
Metaxalone
Methocarbamol
Methohexital
Midazolam
Morphine
Morphine Sulfate Liposome
Nalbuphine
Nitrazepam
Nordazepam
Opium
Oxazepam
Oxycodone
Oxymorphone
Pentazocine
Pentobarbital
Phenobarbital
Prazepam
Propoxyphene
Quazepam
Remifentanil
Secobarbital
Sodium Oxybate
Sufentanil
Tapentadol
Temazepam
Thiopental
Triazolam

Acenocoumarol
Carbamazepine
Isoniazid
Phenytoin
Warfarin
Zidovudine

Interactions with Food/Tobacco/Alcohol

Ethanol

Cabbage
Ethanol

Proper Use of acetaminophen and codeine

This section provides information on the proper use of a number of products that contain acetaminophen and codeine. It may not be specific to Tylenol w/Codeine #3. Please read with care.

Dosing

For oral dosage form (suspension):
- For mild to moderate pain:
  - Adults—15 milliliters (mL) or 1 tablespoonful every 4 hours as needed.
  - Children 7 to 12 years of age—10 mL (2 teaspoonfuls) 3 or 4 times per day.
  - Children 3 to 6 years of age—5 mL (1 teaspoonful) 3 or 4 times per day.
  - Children younger than 3 years of age—Use and dose must be determined by your doctor.
For oral dosage form (tablets):
- For mild to moderately severe pain:
  - Adults—15 to 60 milligrams (mg) of codeine and 300 to 1000 mg of acetaminophen every 4 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 360 mg of codeine and 4000 mg of acetaminophen per 24 hours.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Tylenol w/Codeine #3

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.

For patients taking a codeine-containing medicine or any other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine):

Contact your doctor right away if you have extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an “ultra-rapid metabolizer of codeine”. Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of certain tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Tylenol w/Codeine #3 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Difficult or troubled breathing
irregular, fast or slow, or shallow breathing
pale or blue lips, fingernails, or skin
shortness of breath

Incidence not known

Black, tarry stools
bleeding gums
blood in the urine or stools
cough or hoarseness
difficulty with swallowing
dizziness
fast heartbeat
fever with or without chills
general feeling of tiredness or weakness
hives
itching
lower back or side pain
painful or difficult urination
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
skin rash
sore throat
sores, ulcers, or white spots on the lips or in the mouth
tightness in the chest
unusual bleeding or bruising
unusual tiredness or weakness
wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Abdominal or stomach pain
bloody or cloudy urine
chills
constricted, pinpoint, or small pupils (black part of the eye)
convulsion
dark urine
headache
increased sweating
light-colored stools
loss of appetite
loss of consciousness
nausea
sudden decrease in the amount of urine
unpleasant breath odor
vomiting
vomiting of blood
yellow eyes or skin

More common

Drowsiness
lightheadedness
relaxed and calm
sleepiness

Incidence not known

Difficulty having a bowel movement (stool)
false or unusual sense of well-being

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Advanced,T

Comments (0)

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30/06/10

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Important safety information:

Possible side effects of Tylophen:

If OVERDOSE is suspected:

General information:

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Before Using Tylenol w/Codeine #4

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of acetaminophen and codeine

Dosing

Missed Dose

Storage

Precautions While Using Tylenol w/Codeine #4

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