Tylenol w/Codeine (Oral)

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. However, acetaminophen can cause unwanted effects when taken in large doses, including serious liver damage. Although rare, using acetaminophen has been linked to liver transplantation and death, usually at high doses and when multiple acetaminophen-containing products have been used.

Codeine is part of a group of medicines known as narcotic analgesics (pain medicines). It works on the central nervous system (CNS) to relieve pain.

When codeine is used for a long time, it may become habit-forming, leading to mental or physical dependence. However, people with ongoing pain should not let the fear of dependence stop them from using narcotics to relieve their pain. Mental dependence (addiction) is unlikely to happen when narcotics are used for this reason. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, serious withdrawal side effects can usually be avoided by slowly reducing the dose over time before stopping treatment completely.

This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

It is very important for your doctor to monitor your or your child's progress while taking this medicine, especially during the first 24 to 72 hours of treatment. This will help your doctor determine if the medicine is working properly and if you or your child should continue taking it. Blood tests may be needed to check for unwanted effects.

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

It is illegal 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 may try to steal this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not take 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, seek emergency help immediately. Signs of an overdose include: dark urine, difficulty 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 (e.g., sleep apnea, sleep-related hypoxemia). Your doctor may lower your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

Contact 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 signs of a serious liver problem.

Using this medicine during pregnancy may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Inform your doctor immediately 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 converted to morphine in the body. Some people convert 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," leading to too much morphine in the body and more side effects 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 to remove tonsils or adenoids.
• Children 12 to 18 years of age who are at high risk for breathing problems (e.g., obstructive sleep apnea, obesity, lung disease).

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

For nursing mothers taking this medicine:

• Talk to your doctor if you have any questions about taking codeine or 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 signs of an overdose and require 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 using this medicine.

Dizziness, lightheadedness, or fainting may happen 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 feel 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 increase the effects of alcohol and other CNS depressants (medications that can make you drowsy or less alert). Some examples of CNS depressants include antihistamines or medicines for allergies or colds, sedatives, tranquilizers, or sleeping medications, other prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you consume 3 or more alcoholic beverages while taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while using this medicine.

Using narcotics for a long time can lead to severe constipation. To prevent this, your doctor may advise you to take laxatives, drink plenty of fluids, or eat more fiber. Follow these directions carefully, as ongoing constipation can lead to more serious problems.

Do not change your dose or suddenly stop using this medicine without first consulting 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 risk of withdrawal symptoms, such as stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Contact 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 increase if you are also taking certain other medicines that affect serotonin levels in your body.

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

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

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

In deciding to use a medication, the risks of using the drug must be weighed against the beneficial it will do. This is a decision you and your physician will make. For this drug, the following should be considered:

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform 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 guidance 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 advised 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 following surgery to remove tonsils or adenoids in any children. Severe breathing issues and deaths have been reported in some children who received codeine following tonsil or adenoid surgery.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of acetaminophen and codeine combination in the elderly. Nevertheless, elderly patients are more likely to have age-related liver, kidney, heart, or lung issues, 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 medicine should be prescribed or you should discontinue breastfeeding while using this drug.

Interactions with Drugs

Although certain medications should not be used together at all, in other cases two different drugs 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 drug, it is especially essential that your healthcare professional know if you are using 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 drug with any of the following drugs is not recommended. Your clinician may decide not to treat you with this medication or change some of the other drugs you take.

• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nalmefene
• Naltrexone
• Nialamide
• Ozanimod
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Samidorphan
• Selegiline
• Toloxatone
• Tranylcypromine

Using this drug with any of the following medicines is normally 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 medications.

• 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 medications may cause an increased chance of certain adverse effects, but using both drugs may be the best therapy for you. If both drugs are prescribed together, your doctor may change the dose or how often you use one or both of the medications.

• Acenocoumarol
• Carbamazepine
• Fosphenytoin
• Lixisenatide
• Phenytoin
• Warfarin
• Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain drugs 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 drugs may as well 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 typically not advised, but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Tobacco

Using this medication with any of the following may cause an increased chance of certain adverse effects but may be unavoidable in some cases. If used together, your physician 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

Other Medical Issues

The presence of other medical issues may affect the use of this medication. Make sure you inform your doctor if you have any other medical problems, especially:

• Addison's disease (adrenal gland problem) or
• Alcohol abuse, history of or
• Brain tumor or
• Breathing problems (eg, chronic obstructive pulmonary disease [COPD], cor pulmonale, hypoxia, sleep apnea) or
• CNS depression or
• Drug abuse or dependence, or history of or
• Enlarged prostate or
• Head injuries or
• Hypothyroidism (underactive thyroid) or
• Increased pressure in the head or
• Mental illness, history of or
• Obesity (overweight) or
• Issues with passing urine or
• Weakened physical condition—Use with caution. May increase chance for more serious side effects.

• Allergy to sulfites or
• Asthma—Acetaminophen and codeine combination tablets contains sodium metabisulfite, which can cause allergic reactions in patients with these conditions.

• Asthma, acute or serious or
• Respiratory depression (serious breathing issue) or
• Stomach or bowel blockage (eg, paralytic ileus) or
• Surgery (eg, nasopharyngeal tonsils, tonsils)—Should not be used in patients with these conditions.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased since of slower removal of the drug from the body.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of these side effects occur:

More common

• Difficulty or trouble breathing
• Irregular, fast, 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 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 right away if any of these overdose symptoms 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 blood
• Yellow eyes or skin

Some side effects may occur that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also provide ways to prevent or reduce some of these side effects. Check with your health care professional if any of these side effects continue, 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.

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

In Canada

• pms-Acetaminophen with Codeine
• Teva-EMTEC-30
• Teva-Lenoltec No. 4
• Triatec-30
• Tylenol With Codeine No. 4

Available Dosage Forms:

• Elixir
• Tablet
• Solution

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Codeine

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.