White pill 3 on one side m on the other

What is Tylenol With Codeine?

Oral route (Tablet)

Addiction, Abuse, and Misuse: Acetaminophen and codeine phosphate tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing acetaminophen and codeine phosphate tablets, and monitor all patients regularly for the development of these behaviors or conditions.Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of acetaminophen and codeine phosphate tablets. Monitor for respiratory depression, especially during initiation of acetaminophen and codeine phosphate tablets or following a dose increase.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to; complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.Accidental Ingestion: Accidental ingestion of acetaminophen and codeine phosphate tablets, especially by children, can result in a fatal overdose of acetaminophen and codeine phosphate tablets.Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children: Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy and many of the children had evidence of being ultra-rapid metabolizers of codeine due to CYP2D6 polymorphism. Acetaminophen and codeine phosphate tablets are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of acetaminophen and codeine phosphate tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.Neonatal Opioid Withdrawal Syndrome: Prolonged use of acetaminophen and codeine phosphate tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Interactions with Drugs Affecting Cytochrome P450 Isoenzymes: The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with acetaminophen with codeine requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine.Hepatotoxicity: Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of acetaminophen and codeine phosphate tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Follow patients for signs and symptoms of respiratory depression and sedation .

Oral route (Solution)

Risk of Medication Errors: Ensure accuracy when prescribing, dispensing, and administering acetaminophen and codeine phosphate oral solution. Dosing errors due to confusion between mg and mL, and other codeine containing oral products of different concentrations can result in accidental overdose and death.Addiction, Abuse, and Misuse: Acetaminophen and codeine phosphate oral solution expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing acetaminophen and codeine phosphate oral solution, and monitor all patients regularly for the development of these behaviors or conditions.Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of acetaminophen and codeine phosphate oral solution. Monitor for respiratory depression, especially during initiation of acetaminophen and codeine phosphate oral solution or following a dose increase.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to; complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.Accidental Ingestion: Accidental ingestion of acetaminophen and codeine phosphate oral solution, especially by children, can result in a fatal overdose of acetaminophen and codeine phosphate oral solution.Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children: Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy and many of the children had evidence of being ultra-rapid metabolizers of codeine due to CYP2D6 polymorphism. Acetaminophen and codeine phosphate oral solution are contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of acetaminophen and codeine phosphate oral solution in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.Neonatal Opioid Withdrawal Syndrome: Prolonged use of acetaminophen and codeine phosphate oral solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Interactions with Drugs Affecting Cytochrome P450 Isoenzymes: The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with acetaminophen with codeine oral solution requires careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine.Hepatotoxicity: Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of acetaminophen and codeine phosphate oral solution and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Follow patients for signs and symptoms of respiratory depression and sedation .

Tylenol NO. 3 with Codeine

How does this medication work? What will it do for me?

This combination product contains three medications: acetaminophen, codeine, and caffeine.

Acetaminophen belongs to the group of medications called analgesics (pain relievers) and antipyretics (fever reducers).

Codeine belongs to the group of medications called narcotic analgesics.

Caffeine belongs to the group of medications called stimulants.

This combination of medications is used to treat mild-to-moderate pain associated with conditions such as headache, dental pain, muscle pain, painful menstruation, pain following an accident, and pain following operations.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each round, hard, white, flat-faced tablet, bevelled-edged, engraved with “3” on one side and “McNEIL” on the other, contains 300 mg of acetaminophen and 15 mg of caffeine, in combination with 30 mg of codeine phosphate. Nonmedicinal ingredients: cellulose, pregelatinized starch, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and starch NF. This medication does not contain gluten, lactose, sodium metabisulfite, or tartrazine.

How should I use this medication?

The usual recommended dose for people older than 12 years of age is 1 tablet taken every 4 to 6 hours as required. If 1 tablet is not effective, take 2 tablets at the next dose time. The dose should be adjusted according to the amount of pain experienced. The maximum dose of this medication is 12 tablets in 24 hours. Taking more than 12 tablets (or a maximum of 4000 mg of acetaminophen) in a 24-hour period may cause severe liver damage, and could be fatal.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Acetaminophen should not be taken to relieve pain for more than 5 days or to relieve a fever for more than 3 days, unless directed by a doctor.

It is important to take this medication exactly as prescribed by your doctor. If your doctor has told you to take this medication on a regular basis and you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to to acetaminophen, caffeine, codeine, or any ingredients of the medication
  • are overdosed on or intoxicated by alcohol, hypnotics, analgesics, or psychotropic medications
  • are 12 years of age or younger
  • are 18 years of age or younger and are having or have recently had surgery for removal tonsils or adenoids
  • are experiencing acute asthma or other obstructive airway disease
  • are experiencing acute respiratory depression
  • are taking a monoamine oxidase (MAO) inhibitor (e.g., phenelzine, tranylcypromine) or have taken one in the last 14 days
  • have a blockage of the gastrointestinal tract, particularly paralytic ileus
  • have a head injury, a brain tumour, or increased pressure inside the head or spinal cord
  • have a convulsive (seizure) disorder
  • have a suspected abdominal condition that may require surgery
  • have severely reduced liver or kidney function
  • are a known CYP2D6 ultra-rapid metabolizer (someone who converts codeine into its active metabolite more rapidly and completely)
  • are pregnant or breast-feeding, in labour, or delivering

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • dizziness
  • drowsiness
  • lightheadedness
  • nausea
  • vomiting

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • abdominal pain
  • headache
  • itching
  • mood changes
  • nervousness
  • restlessness
  • shortness of breath
  • signs of breathing problems (e.g., shortness of breath, wheezing, irregular or troubled breathing)
  • skin rash
  • stomach upset
  • trouble sleeping

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • confusion
  • hallucinations
  • signs of a serious allergic reaction (i.e., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

July 28, 2016

Health Canada has issued new restrictions concerning the use of prescription codeine. To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.

July 9, 2015

Health Canada has issued new restrictions concerning the use of acetaminophen. To read the full Health Canada Advisory, visit Health Canada’s web site at www.hc-sc.gc.ca.

Abdominal conditions: Codeine may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have an abdominal condition such as inflammatory or obstructive bowel disease, acute cholecystitis, or pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Alcohol use: If you regularly drink large amounts of alcohol, talk to your doctor about the increased risk for liver damage related to the acetaminophen component of this medication and how to use this medication safely.

Breathing: Codeine can suppress breathing. If you are at risk for breathing difficulties (e.g., if you have asthma or chronic lung disease), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Constipation: Codeine can be very constipating. Eating a high-fibre diet and following good bowel habits will help to minimize this effect. If you develop constipation easily, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dependence and withdrawal: This medication contains codeine. Physical dependence, psychological dependence, and abuse have occurred with the use of codeine. People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication. Abuse is not a problem with people who require this medication for pain relief.

If you suddenly stop taking this medication, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shaking, pain, nausea, tremors, diarrhea, and hallucinations. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor.

Drowsiness/reduced alertness: This medication may cause drowsiness. Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how this medication affects you.

Head injury: If you have a head injury or increased pressure in the head, you may have a higher risk of experiencing side effects (breathing problems) or worsening of your condition while taking this medication. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: If you have kidney disease or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Acetaminophen can cause decreased liver function. If you have liver disease or reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Taking too much acetaminophen with codeine may cause liver problems.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Other medical conditions: If you are about to undergo surgery of the biliary tract, approach taking codeine with caution, as it may worsen your condition. Codeine will worsen the effects of acute alcohol intoxication and delirium tremens.

As well, if you have low thyroid (hypothyroidism), Addison’s disease, benign prostatic hypertrophy (enlarged prostate), gallbladder disease, urethral stricture, decreased function of the adrenal glands, or porphyria, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Ultra-rapid codeine metabolizers: Some people process codeine faster and more completely than others due to a genetic variation. This can result in higher-than-expected drug levels in the body, which may result in overdose symptoms and serious or life-threatening effects on breathing. If you are known to be a rapid metabolizer of codeine you should avoid using this medication.

Worsening symptoms: If redness or swelling occurs in the area of pain, if symptoms do not improve or they worsen, or if new symptoms develop (e.g., high fever, rash, itching, persistent headache) while you are taking this medication, contact your doctor as soon as possible. These may be signs of other conditions that require medical attention.

Seizures: This medication may cause seizures. Seizures are more likely to occur when higher doses of this medication are taken. If you have a history of epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Acetaminophen, codeine, and caffeine pass into breast milk. Some of the codeine dose is converted into morphine by the body, once it has been taken. For some people, this change happens much faster than for others. If this happens to a nursing mother, the baby is a risk of receiving a morphine overdose through the breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under 12 years of age. Medications containing codeine should not be given to people under the age of 18 for pain management after surgery to remove the tonsils and or adenoids.

Seniors: Seniors who take this medication may be more likely to experience side effects or worsening of preexisting medical conditions.

What other drugs could interact with this medication?

There may be an interaction between acetaminophen – codeine – caffeine and any of the following:

  • abiraterone acetate
  • aclidinium
  • alcohol
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • atropine
  • azelastine
  • baclofen
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
  • belladonna
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • benztropine
  • brimonidine
  • buprenorphine
  • bupropion
  • buspirone
  • butorphanol
  • celecoxib
  • cinacalcet
  • chloral hydrate
  • cholestyramine
  • chloroquine
  • cocaine
  • darifenacin
  • delavirdine
  • desmopressin
  • disopyramide
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • dofetilide
  • dronabinol
  • dronedarone
  • efavirenz
  • flavoxate
  • general anaesthetics (medications used to put people to sleep before surgery)
  • glycopyrrolate
  • ipratropium
  • isoniazid
  • kava kava
  • ketoconazole
  • ketotifen
  • lithium
  • lopinavir
  • magnesium sulphate
  • monoamine oxidase (MAO) inhibitors (e.g., moclobemide, phenelzine, selegiline, tranylcypromine)
  • methadone
  • metyrosine
  • mirabegron
  • mirtazapine
  • muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
  • nabilone
  • naltrexone
  • other narcotic pain relievers (e.g., fentanyl, hydrocodone, morphine)
  • octreotide
  • olopatadine
  • other products containing acetaminophen, caffeine, or codeine
  • oxybutynin
  • perampanel
  • phenylephrine
  • pramipexole
  • prilocaine
  • probenecid
  • quinidine
  • quinine
  • ritonavir
  • ropinirole
  • rifampin
  • rufinamide
  • scopolamine
  • seizure medications (e.g., clobazam, ethosuximide, felbamate, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
  • tapentadol
  • terbinafine
  • thalidomide
  • ticlopidine
  • tiotropium
  • tolterodine
  • tramadol
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • “triptan” migraine medications (e.g., rizatriptan, sumatriptan)
  • tyrosine kinase inhibitors (e.g., dasatinib, imatinib, nilotinib)
  • umeclidinium
  • vaccines
  • warfarin
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Tylenol-NO-3-with-Codeine

Codeine

Generic Name: codeine (KOE deen)
Brand Names:

Medically reviewed by Sanjai Sinha, MD Last updated on Nov 29, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Tips
  • Interactions
  • More

What is codeine?

Codeine is an opioid pain medication, sometimes called a narcotic.

Codeine is used to treat mild to moderately severe pain.

Codeine may also be used for purposes not listed in this medication guide.

Important Information

You should not use codeine if you have severe breathing problems, a blockage in your stomach or intestines, or frequent asthma attacks or hyperventilation.

Codeine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Codeine is not for use in anyone under 18 years old.

Taking codeine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use codeine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Before taking this medicine

You should not use this medicine if you are allergic to it, or if you have:

  • severe asthma or breathing problems;

  • a blockage in your stomach or intestines; or

  • frequent asthma attacks or hyperventilation.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

Do not give codeine to anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • liver disease;

  • breathing problems, sleep apnea;

  • asthma, COPD, sleep apnea, or other breathing disorders;

  • abnormal curvature of the spine that affects breathing;

  • kidney disease;

  • a head injury or brain tumor;

  • low blood pressure;

  • blockage in your digestive tract (stomach or intestines);

  • a gallbladder or pancreas disorder;

  • underactive thyroid;

  • Addison’s disease or other adrenal gland disorder;

  • enlarged prostate, urination problems; or

  • mental illness, drug or alcohol addiction.

Some medicines can interact with codeine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

If you use this medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breast-feed while taking codeine. This medicine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

How should I take codeine?

Take codeine exactly as prescribed by your doctor. Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Codeine may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away codeine is against the law.

Take this medicine with food or milk if it upsets your stomach.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking this medicine. Do not use a stool softener (laxative) without first asking your doctor.

Do not stop using codeine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

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

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag throw the bag in the trash.

What happens if I miss a dose?

Since this medicine is used for pain, you are not likely to miss a dose. Skip any 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. A codeine overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose can cause severe muscle weakness, cold and clammy skin, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.

What should I avoid while taking codeine?

Do not drink alcohol. Dangerous side effects or death could occur.

Codeine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Codeine side effects

Get emergency medical help if you have signs of an allergic reaction to codeine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, codeine can slow your breathing. Death may occur if breathing becomes too weak.

A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing, breathing that stops during sleep;

  • a slow heart rate or weak pulse;

  • a light-headed feeling, like you might pass out;

  • confusion, agitation, hallucinations, unusual thoughts or behavior;

  • feelings of extreme happiness or sadness;

  • seizure (convulsions);

  • problems with urination; or

  • low cortisol levels–nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common codeine side effects include:

  • feeling dizzy or drowsy;

  • nausea, vomiting, stomach pain;

  • constipation;

  • sweating; or

  • mild itching or rash.

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.

Codeine dosing information

Usual Adult Dose for Pain:

Initial dose: 15 to 60 mg orally up to every 4 hours as needed
Maximum dose: 360 mg in 24 hours

-Initial doses should be individualized taking into account severity of pain, response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.
-Doses higher than 60 mg have not been shown to improve pain relief and are associated with an increased incidence of adverse effects.
-Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.
Use: For the management of mild to moderate pain where treatment with an opioid is appropriate and from which alternative treatments are inadequate.

What other drugs will affect codeine?

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);

  • medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

  • other narcotic medications – opioid pain medicine or prescription cough medicine;

  • a sedative like Valium – diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

  • drugs that make you sleepy or slow your breathing – a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

  • drugs that affect serotonin levels in your body- a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use codeine only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 14.03.

Related questions

  • What’s the difference between Par promethazine with codeine and Hi-Tech promethazine with codeine?

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  • Pain
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Acetaminophen — better known by the brand name Tylenol — is an over-the-counter pain reliever. It can be used to help with mild to moderate headaches, muscle aches, backaches, sore throats and other cold symptoms, menstrual cramps, toothaches and reactions to shots. It is also sometimes used to help ease the pain of osteoarthritis.

Acetaminophen is the name used in the United States and Japan; internationally, the drug is known as paracetamol. It is sold under dozens of brand names, including Tylenol, Panadol and Mapap. It’s also a component in more than 100 medications, including Alka-Seltzer Plus Cold & Sinus, NyQuil Cold/Flu Relief, Percocet and Excedrin.

Acetaminophen belongs to drug classes analgesics (pain relievers) and antipyretics (fever reducers). It works by elevating the pain threshold so that only more intense pain is felt. It also tells the brain to cool off the body during fever.

However, unlike nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin and ibuprofen, acetaminophen does not reduce inflammation, according to Harvard Medical School. But while NSAIDs can irritate the stomach and intestinal lining, acetaminophen does not.

Dosage

Acetaminophen is available as a tablet, chewable tablet, capsule, liquid, drops (no longer produced in the United States), extended-release tablet, orally disintegrating tablet and rectal suppository. Oral forms can be taken with or without food. It is important not to crush or chew extended-release tablets, as this can increase the risk of side effects since the medicine will be released all at once.

Acetaminophen will is likely most effective if taken when the first signs of pain occur, according to the National Institutes of Health (NIH).

The NIH recommends that doses not exceed 4,000 milligrams of acetaminophen per day (the amount of eight Extra Strength Tylenol). If taking acetaminophen for fever, do not take it for more than three days unless directed by a doctor. For pain relief, adults should not take acetaminophen for more than 10 days and children should not take it for more than five, unless directed by a doctor.

Do not give children acetaminophen products that are made for adults. Determine a child’s dose of acetaminophen products based on his or her weight or age.

Acetaminophen may be included in other medications for coughs or colds. It is important to check the labels carefully if using two or more products at the same time, as taking multiple medications containing the same active ingredient(s) could cause an overdose.

Side effects

According to the NIH, the following are serious side effects of acetaminophen. If experienced, call a doctor immediately and stop taking the drug:

  • Red, peeling or blistering skin
  • rash
  • hives
  • itching
  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • hoarseness
  • difficulty breathing or swallowing

Overdose

According to the NIH, “acetaminophen overdose is one of the most common poisonings worldwide.” Although it is usually quite safe in small doses, it can be dangerous or even deadly if taken in large quantities.

The NIH lists the following as symptoms of acetaminophen overdose:

  • nausea
  • vomiting
  • loss of appetite
  • sweating
  • extreme tiredness
  • unusual bleeding or bruising
  • pain in the upper right part of the stomach
  • yellowing of the skin or eyes
  • flu-like symptoms

In case of these symptoms, patients should seek medical help immediately. Treatment may include N-acetylcysteine, an antidote that can treat acetaminophen overdose, although it works best if given within eight to 10 hours of the overdose, according to the Utah Poison Control Center. Other emergency room treatment may include laxatives, poison antidotes, and activated charcoal. If a large overdose goes untreated, it may lead to liver damage or death within just a few days.

Toxicity

In August 2013, the FDA issued a safety announcement about three rare, but potentially lethal, skin disorders that are associated with acetaminophen. The disorders are Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. Any patient who has a skin reaction, including a rash or a blister, while taking acetaminophen should immediately stop taking the drug and seek emergency medical attention.

In response to this warning, concentrated forms and drops of acetaminophen for children are no longer being produced in the United States.

Liver damage

In the United States, acetaminophen is the most common cause of acute hepatic failure and the second most common cause of liver failure requiring a transplant.

On January of 2014, the FDA issued a statement “recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams of acetaminophen per tablet, capsule or other dosage unit.” Though the risk of liver damage from overdose of acetaminophen has long-been known, this most recent recommendation is targeted at reducing the number of people who overdose by unknowingly taking too many medications that contain acetaminophen.

Liver damage occurs when the liver’s glutathione pathway is overwhelmed by too much of acetaminophen’s metabolite, NAPQI. Toxic compounds then accumulate in the liver and damage it. There are three symptomatic phases of liver damage: nausea, vomiting, loss of appetite, and other flu-like symptoms; an inactive phase during which there is no discomfort; and the appearance of liver blood test abnormalities. For this reason, it is important to seek medical help when initial symptoms appear.

Patients should be sure to tell their doctor if they have any history of liver problems or drink more than two alcoholic beverages per day.

In fact, drinking alcohol can cause the liver to convert acetaminophen in your body into toxic byproducts, according to Harvard Medical School. To safeguard against this, men taking acetaminophen shouldn’t have more than two alcoholic drinks per day, and women shouldn’t have more than one alcoholic drink per day.

Hydrocodone and acetaminophen

Hydrocodone is a strong narcotic pain reliever. It is sometimes combined with acetaminophen (a non-narcotic) for increased pain relief. It is prescribed to relieve moderate to severe pain and is a main ingredient in many prescription painkillers.

Hydrocodone may be habit-forming. Combined with acetaminophen, it may impair thinking or reactions. It may be best not to drive or do anything that requires alertness while taking this medicine.

Codeine and acetaminophen

A combination medicine of codeine and acetaminophen may be prescribed to treat mild to moderately severe pain. Codeine is narcotic pain reliever and can also be habit forming, so it is important not to exceed the prescribed dose. According to the NIH, serious side effects are difficulty breathing and mood changes, and if experienced, a doctor should be consulted immediately.

Pregnancy

Acetaminophen may affect fetal development during pregnancy, research shows. For instance, a 2016 study in the journal JAMA Pediatrics found that women who took acetaminophen during pregnancy were more likely to have children who later developed behavioral problems, Live Science previously reported. The study included surveys from nearly 8,000 women living in the United Kingdom, and followed up with the women once their children turned 7 years old.

According to a 2014 JAMA Pediatrics study, women who took acetaminophen during pregnancy had a higher risk of having children with attention-deficit/hyperactivity disorder (ADHD), Live Science previously reported. This Danish study included 65,000 women who gave birth between 1996 and 2002.

Likewise, a 2011 review found a link between a woman’s acetaminophen use during pregnancy and children’s risk for asthma, and another 2014 study found that children whose mothers used acetaminophen for more than 28 days during pregnancy had poorer motor development and communication compared with their siblings, Live Science previously reported.

This article is for informational purposes only, and is not meant to offer medical advice. This article was updated on Oct. 5, 2018 by Live Science Senior Writer, Laura Geggel.

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