Tylenol with Codeine No. 3

Generic name: Acetaminophen And Codeine
Drug class: Narcotic analgesic combinations

Usage of Tylenol with Codeine No. 3

Acetaminophen and codeine combination is used to relieve mild to moderate 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 serious liver damage. Although rare, use of acetaminophen has been reported to lead to liver transplantation and death, usually at high doses and when multiple acetaminophen-containing products have been used.

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 under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program .

Tylenol with Codeine No. 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 trouble breathing

irregular, fast or slow, or shallow breathing

pale or blue lips, fingernails, or skin

Incidence not known

Black, tarry stools

bleeding gums

blood in the urine or stools

cough

difficulty with swallowing

dizziness

fast heartbeat

fever with or without chills

general feeling of tiredness or weakness

hives, itching, skin rash

hoarseness

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

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

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

Symptoms of overdose

Bloody or cloudy urine

chills

constricted, pinpoint, or small pupils (black part of the eye)

dark urine

headache

increased sweating

light-colored stools

loss of appetite

loss of consciousness

nausea

seizures

stomach pain

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 feeling

sleepiness

Incidence not known

Difficulty having a bowel movement

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.

Before taking Tylenol with Codeine No. 3

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 combination 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 Tylenol® with codeine tablets in the pediatric population. Use of acetaminophen and codeine combination oral solution or tablets is not recommended in children younger than 12 years of age. Safety and efficacy have not been established.

Acetaminophen and codeine combination should not be used to relieve pain after surgery to remove tonsils or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of acetaminophen and codeine combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving acetaminophen and codeine combination.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

Furazolidone

Iproniazid

Isocarboxazid

Linezolid

Methylene Blue

Moclobemide

Nalmefene

Naltrexone

Nialamide

Ozanimod

Phenelzine

Procarbazine

Rasagiline

Safinamide

Samidorphan

Selegiline

Toloxatone

Tranylcypromine

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.

Abametapir

Abiraterone Acetate

Acepromazine

Aclidinium

Alfentanil

Almotriptan

Alosetron

Alprazolam

Amantadine

Amifampridine

Amiloride

Amineptine

Amiodarone

Amitriptyline

Amitriptylinoxide

Amobarbital

Amoxapine

Amphetamine

Amprenavir

Anileridine

Apalutamide

Aprepitant

Aripiprazole

Aripiprazole Lauroxil

Armodafinil

Asenapine

Atazanavir

Atropine

Baclofen

Belladonna

Bemetizide

Bendroflumethiazide

Benperidol

Bentazepam

Benzhydrocodone

Benzphetamine

Benzthiazide

Benztropine

Biperiden

Boceprevir

Bosentan

Bromazepam

Bromopride

Brompheniramine

Bumetanide

Buprenorphine

Bupropion

Buspirone

Butabarbital

Butorphanol

Calcium Oxybate

Cannabidiol

Cannabis

Canrenoate

Canrenone

Carbamazepine

Carbinoxamine

Carisoprodol

Carphenazine

Cenobamate

Cetirizine

Chloral Hydrate

Chlordiazepoxide

Chlorothiazide

Chlorpheniramine

Chlorpromazine

Chlorthalidone

Chlorzoxazone

Cimetidine

CinaCalcet

Ciprofloxacin

Citalopram

Clarithromycin

Clemastine

Clidinium

Clobazam

Clomipramine

Clonazepam

Clopamide

Clopidogrel

Clorazepate

Cloxazolam

Clozapine

Cobicistat

Cocaine

Conivaptan

Crizotinib

Cyclobenzaprine

Cyclopenthiazide

Cyclopentolate

Cyclosporine

Cyclothiazide

Cyproheptadine

Daridorexant

Darifenacin

Darunavir

Delavirdine

Delorazepam

Desipramine

Desmopressin

Desvenlafaxine

Dexamethasone

Dexmedetomidine

Dextroamphetamine

Dextromethorphan

Dezocine

Diacetylmorphine

Diazepam

Diazoxide

Dibenzepin

Dichloralphenazone

Dicyclomine

Difenoxin

Dihydrocodeine

Diltiazem

Dimenhydrinate

Diphenhydramine

Diphenoxylate

Dolasetron

Donepezil

Doxepin

Doxylamine

Dronedarone

Droperidol

Duloxetine

Efavirenz

Elagolix

Eletriptan

Enflurane

Enzalutamide

Eplerenone

Erythromycin

Escitalopram

Esketamine

Eslicarbazepine Acetate

Estazolam

Eszopiclone

Ethacrynic Acid

Ethchlorvynol

Ethopropazine

Ethylmorphine

Etozolin

Etravirine

Fedratinib

Fenfluramine

Fentanyl

Fesoterodine

Fexinidazole

Flavoxate

Flibanserin

Fluconazole

Flunitrazepam

Fluoxetine

Fluphenazine

Flurazepam

Fluspirilene

Fluvoxamine

Fosamprenavir

Fosaprepitant

Fosnetupitant

Fosphenytoin

Fospropofol

Frovatriptan

Furosemide

Gabapentin

Gabapentin Enacarbil

Gepirone

Glycopyrrolate

Glycopyrronium Tosylate

Granisetron

Halazepam

Haloperidol

Halothane

Hexobarbital

Homatropine

Hydrochlorothiazide

Hydrocodone

Hydroflumethiazide

Hydromorphone

Hydroxytryptophan

Hydroxyzine

Hyoscyamine

Idelalisib

Imatinib

Imipramine

Indapamide

Indinavir

Ipratropium

Isoflurane

Isoniazid

Itraconazole

Ivacaftor

Ketamine

Ketazolam

Ketobemidone

Ketoconazole

Lacosamide

Larotrectinib

Lasmiditan

Lemborexant

Lenacapavir

Letermovir

Levocetirizine

Levomilnacipran

Levorphanol

Lisdexamfetamine

Lithium

Lofepramine

Lofexidine

Lomitapide

Lopinavir

Loprazolam

Lorazepam

Lorcaserin

Lorlatinib

Lormetazepam

Loxapine

Lumacaftor

Magnesium Oxybate

Mavacamten

Meclizine

Medazepam

Melitracen

Melperone

Mepenzolate

Meperidine

Mephobarbital

Meprobamate

Meptazinol

Mesoridazine

Metaclazepam

Metaxalone

Methadone

Methamphetamine

Methdilazine

Methocarbamol

Methohexital

Methotrimeprazine

Methyclothiazide

Metoclopramide

Metolazone

Mibefradil

Midazolam

Mifepristone

Milnacipran

Mirabegron

Mirtazapine

Mitotane

Modafinil

Molindone

Moricizine

Morphine

Morphine Sulfate Liposome

Nafcillin

Nalbuphine

Naratriptan

Nefazodone

Nelfinavir

Netupitant

Nevirapine

Nicomorphine

Nilotinib

Nitrazepam

Nitrous Oxide

Nordazepam

Nortriptyline

Olanzapine

Omaveloxolone

Ondansetron

Opipramol

Opium

Opium Alkaloids

Orphenadrine

Oxazepam

Oxcarbazepine

Oxitropium Bromide

Oxybutynin

Oxycodone

Oxymorphone

Palbociclib

Palonosetron

Papaveretum

Paregoric

Paroxetine

Pentazocine

Pentobarbital

Perampanel

Perazine

Periciazine

Perphenazine

Phenobarbital

Phenytoin

Pinazepam

Pipenzolate Bromide

Piperacetazine

Pipotiazine

Pirenzepine

Piretanide

Piritramide

Pixantrone

Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate

Polythiazide

Posaconazole

Potassium Oxybate

Prazepam

Prednisone

Pregabalin

Primidone

Prochlorperazine

Procyclidine

Promazine

Promethazine

Propantheline

Propiverine

Propofol

Protriptyline

Quazepam

Quetiapine

Quinethazone

Quinidine

Quinine

Ramelteon

Ranitidine

Ranolazine

Remifentanil

Remimazolam

Remoxipride

Rifabutin

Rifampin

Rifapentine

Ritonavir

Rizatriptan

Rolapitant

Ropeginterferon Alfa-2b-njft

Saquinavir

Scopolamine

Secobarbital

Sertindole

Sertraline

Sibutramine

Sodium Oxybate

Solifenacin

Spironolactone

St John's Wort

Stramonium

Sufentanil

Sulpiride

Sumatriptan

Suvorexant

Tapentadol

Telaprevir

Telithromycin

Temazepam

Terbinafine

Terodiline

Tetrazepam

Thiethylperazine

Thiopental

Thiopropazate

Thioridazine

Thiothixene

Tianeptine

Tilidine

Tiotropium

Tizanidine

Tocilizumab

Tolonium Chloride

Tolterodine

Topiramate

Torsemide

Tramadol

Trazodone

Triamterene

Triazolam

Trichlormethiazide

Trifluoperazine

Trifluperidol

Triflupromazine

Trihexyphenidyl

Trimeprazine

Trimipramine

Tropicamide

Trospium

Tryptophan

Umeclidinium

Venlafaxine

Verapamil

Vilazodone

Voriconazole

Vortioxetine

Voxelotor

Xipamide

Zaleplon

Ziprasidone

Zolmitriptan

Zolpidem

Zopiclone

Zotepine

Zuranolone

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

Fosphenytoin

Lixisenatide

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

Tobacco

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

Relate drugs

How to use Tylenol with Codeine No. 3

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. Also, large amounts of acetaminophen may cause liver damage if taken for a long time.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of acetaminophen and codeine combination. This medicine should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

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), as this may increase the risk for serious liver problems.

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.

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 mild to moderate pain:

For oral dosage form (solution):

Adults—15 milliliters (mL) every 4 hours as needed. Your doctor may adjust your dose as needed.

Children—Use and dose must be determined by your doctor.

For oral dosage form (suspension):

Adults—15 milliliters (mL) every 4 hours as needed.

Children 7 to 12 years of age—10 mL 3 or 4 times per day.

Children 3 to 6 years of age—5 mL 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):

Adults—1 or 2 tablets every 4 hours as needed. Your doctor may adjust your dose as needed.

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.

If you miss a dose of the oral solution or tablet, skip the missed dose and go back to your regular dosing schedule.

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.

Acetaminophen and codeine combination oral solution or tablet can cause serious unwanted effects or fatal overdose if taken by children, pets, or adults who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website:www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm .

Warnings

It is very important that your doctor check your or your child's progress while you are taking this medicine, especially within the first 24 to 72 hours of treatment. 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. Blood tests may be needed to check for unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused medicine in a safe and secure place. People who are addicted to drugs might want to steal 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. Call your doctor for instructions.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include: dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, nausea, vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your child has the following symptoms: an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, sneezing, weight loss, vomiting, yawning, or failure to gain weight. Check with your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". As a result, there is too much morphine in the body and more side effects of morphine than usual. Children may be especially sensitive to this effect. Do not give this medicine to:

Children younger than 12 years of age.

Children younger than 18 years of age who have had surgery removal of tonsils or adenoids.

Children 12 to 18 years of age who have a high risk for breathing problems (eg, obstructive sleep apnea, obesity, lung disease).

If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to morphine overdose in the nursing baby and cause very serious side effects.

For nursing mothers taking this medicine:

Talk to your doctor if you have any questions about taking codeine or about how this medicine may affect your baby.

Call your doctor if you become extremely tired and have difficulty caring for your baby.

Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.

Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, confused, or disoriented. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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 3 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.

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.

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 stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

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.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

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.

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