Vopac (Oral)

Acetaminophen and codeine combination is made use of to relieve moderate to modest discomfort.

Acetaminophen is used to relieve discomfort and decrease fever in clients. It does not come to be habit-forming when considered a very long time. Yet acetaminophen might create other unwanted impacts when absorbed huge dosages, consisting of severe liver damage. Although rare, use acetaminophen has been reported to bring about liver transplant and death, normally at high doses and when numerous acetaminophen-containing products have actually been made use of.

Codeine belongs to the group of medications called narcotic analgesics (discomfort medicines). It acts upon the main nerve system (CNS) to relieve discomfort.

When codeine is made use of for a long time, it may become habit-forming, creating mental or physical dependancy. Nonetheless, people that have continuing pain should not allow the fear of dependence keep them from using narcotics to relieve their pain. Mental dependancy (dependency) is not likely to take place when narcotics are utilized for this function. Physical reliance may bring about withdrawal adverse effects if treatment is quit all of a sudden. However, extreme withdrawal side effects can usually be avoided by slowly decreasing the dosage over a time period prior to treatment is quit totally.

This medicine is offered just under a limited distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

It is extremely important that your medical professional check your or your kid's development while you are taking this medicine, specifically within the very first 24 to 72 hours of treatment. This will allow your medical professional to see if the medicine is working effectively and to determine if you or your child ought to remain to take it. Blood examinations may be needed to look for undesirable results.

Do not utilize this medication if you are utilizing or have actually utilized an MAO prevention (MAOI) such as isocarboxazid [Marplan ®], linezolid [Zyvox ®], phenelzine [Nardil ®], selegiline [Eldepryl ®], tranylcypromine [Parnate ®] within the previous 14 days.

It protests the regulation and dangerous for anybody else to utilize your medicine. Maintain your extra medicine in a safe and safe and secure place. Individuals who are addicted to drugs may wish to swipe this medication.

This medication may be habit-forming. If you really feel that the medicine is not working also, do not make use of more than your suggested dose. Call your physician for guidelines.

If you assume you or somebody else might have taken an overdose of this medication, obtain emergency assistance at the same time. Indicators of an overdose include: dark urine, difficult or trouble breathing, irregular, fast or sluggish, or superficial breathing, nausea, vomiting, pain in the upper stomach, pale or blue lips, finger nails, or skin, identify students of the eyes, or yellow eyes or skin.

This medicine may create sleep-related breathing troubles (eg, sleep apnea, sleep-related hypoxemia). Your physician may reduce your dose if you have sleep apnea (quit breathing for short durations throughout sleep) while utilizing this medicine.

Contact your physician as soon as possible if you have discomfort or inflammation in the top stomach, light feceses, dark urine, anorexia nervosa, nausea or vomiting, uncommon fatigue or weakness, or yellow eyes or skin. These might be signs of a serious liver problem.

Utilizing this medication while you are expectant may trigger major undesirable impacts, consisting of neonatal withdrawal syndrome in your newborn baby. Inform your physician today if your youngster has the following signs: an irregular rest pattern, looseness of the bowels, a high-pitched cry, irritation, shakiness or tremblings, sneezing, weight-loss, vomiting, yawning, or failure to gain weight. Consult your physician immediately if you believe you are pregnant or if you intend to conceive while utilizing this medication.

Codeine is changed to morphine in the body. Some individuals alter codeine to morphine more quickly than others. These people are called "ultra-rapid metabolizers of codeine". Get in touch with your physician instantly if you experience severe sleepiness, complication, or superficial breathing. These signs and symptoms may show that you are an "ultra-rapid metabolizer of codeine". Because of this, there is way too much morphine in the body and even more side effects of morphine than typical. Kids may be specifically sensitive to this result. Do not give this medicine to:

• Children more youthful than 12 years old.
• Children more youthful than 18 years old that have actually had surgical treatment elimination of tonsils or adenoids.
• Children 12 to 18 years old who have a high threat for breathing problems (eg, obstructive rest apnea, excessive weight, lung disease).

If a nursing mother is an ultra-rapid metabolizer of codeine, it can lead to morphine overdose in the nursing infant and trigger really major negative effects.

For nursing mothers taking this medicine:

• Talk to your doctor if you have any type of questions concerning taking codeine or regarding exactly how this medicine may affect your baby.
• Call your doctor if you come to be exceptionally exhausted and have problem caring for your baby.
• Your infant should usually registered nurse every 2 to 3 hours and ought to not rest for more than 4 hours each time.
• Check with your doctor or health center emergency room instantly if your infant reveals signs of boosted sleepiness (greater than common), problem nursing, problem breathing, or limpness. These may be signs and symptoms of an overdose and require prompt clinical interest.

This medicine might cause major allergic reactions, including anaphylaxis, angioedema, or specific skin problem (Stevens-Johnson syndrome). These responses can be dangerous and require prompt medical interest. Call your doctor as soon as possible if you have a breakout, itching, blistering, peeling, or helping to loosen of the skin, high temperature or cools, problem breathing or ingesting, or any swelling of your hands, face, mouth, or throat while you are utilizing this medicine.

Dizziness, faintness, or fainting might happen when you stand up unexpectedly from a lying or sitting position. Rising slowly might help. Also, relaxing for some time might ease lightheadedness or faintness.

This medicine may make you lightheaded, sleepy, confused, or dizzy. Do not drive or do anything else that might be harmful till you know exactly how this medication influences you.

This medicine will certainly add to the impacts of alcohol and other CNS downers (medicines that can make you sleepy or less sharp). Some instances of CNS depressants are antihistamines or medication for allergic reactions or colds, sedatives, tranquilizers, or resting medication, other prescription discomfort medicine or narcotics, medication for seizures or barbiturates, muscular tissue relaxants, or anesthetics, including some oral anesthetics. Also, there may be a better risk of liver damage if you consume alcohol 3 or even more alcohols while you are taking acetaminophen. Do not drink alcohols, and get in touch with your physician prior to taking any one of these medicines while you are using this medicine.

Making use of narcotics for a very long time can create serious irregular bowel movements. To prevent this, your physician may guide you to take laxatives, drink a lot of fluids, or enhance the quantity of fiber in your diet. Be sure to follow the instructions carefully, because continuing constipation can lead to a lot more major issues.

Do not transform your dosage or suddenly stop using this medication without first monitoring with your doctor. Your doctor might want you to slowly minimize the quantity you are making use of prior to quiting it totally. This may aid stop intensifying of your condition and decrease the opportunity of withdrawal signs, such as stomach aches, anxiousness, high temperature, nausea, drippy nose, sweating, tremblings, or difficulty with sleeping.

Contact your physician today if you have anxiety, uneasyness, a rapid heartbeat, fever, sweating, muscle convulsions, shivering, nausea, vomiting, looseness of the bowels, or see or hear points that are not there. These may be signs of a major problem called serotonin syndrome. Your risk may be higher if you additionally take certain various other medications that affect serotonin levels in your body.

Before you have any kind of clinical tests, inform the medical physician in charge that you or your kid are taking this medicine. The outcomes of particular examinations might be affected by this medication.

Utilizing excessive of this medicine may cause the inability to conceive (unable to have children). Talk with your medical professional before utilizing this medicine if you prepare to have youngsters.

Do not take other medications unless they have actually been talked about with your doctor. This includes prescription or nonprescription (over-the-counter [OTC] medications and organic or vitamin supplements.

In choosing to use a medicine, the threats of taking the medication should be weighed versus the excellent it will certainly do. This is a decision you and your doctor will make. For this medicine, the adhering to must be thought about:

Allergies

Tell your medical professional if you have ever had any unusual or allergic reaction to this medicine or any type of other medications. Additionally inform your healthcare expert if you have any kind of various other sorts of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription items, checked out the tag or bundle ingredients very carefully.

Pediatric

Suitable studies have actually not been performed on the partnership of age to the impacts of acetaminophen and codeine combination oral suspension in kids younger than 3 years of age. Security and effectiveness have not been developed.

No info is offered on the relationship old to the results of Tylenol ® with codeine tablet computers in the pediatric population. Use of acetaminophen and codeine combination oral option or tablet computers is not suggested in children more youthful than 12 years old. Safety and security and effectiveness have actually not been developed.

Acetaminophen and codeine combination must not be made use of to ease discomfort after surgery to eliminate tonsils or adenoids in any type of kids. Severe breathing troubles and fatalities have been reported in some kids who received codeine after tonsil or adenoid surgery.

Geriatric

Proper research studies executed to date have actually not demonstrated geriatric-specific troubles that would certainly restrict the effectiveness of acetaminophen and codeine combination in the elderly. Nonetheless, elderly people are more probable to have age-related liver, kidney, heart, or lung troubles, which might need caution and an adjustment in the dosage for patients receiving acetaminophen and codeine mix.

Breast Feeding

Studies in ladies nursing have actually shown dangerous infant effects. An option to this medication need to be recommended or you need to stop nursing while utilizing this medicine.

Interactions with Medicines

Although specific medicines need to not be utilized together whatsoever, in other situations two different medications might be made use of together even if an interaction might occur. In these situations, your physician may intend to change the dosage, or other precautions might be required. When you are taking this medicine, it is especially vital that your health care specialist understand if you are taking any of the medicines listed below. The complying with interactions have been chosen on the basis of their potential relevance and are not always all-inclusive.

Utilizing this medication with any of the adhering to medications is not suggested. Your doctor might determine not to treat you with this medicine or alter several of the various other medications 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 one of the complying with medications is generally not recommended, however might be called for sometimes. If both medicines are suggested with each other, your doctor might alter the dosage or how frequently you make use of 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 medications might cause a raised threat of particular adverse effects, yet utilizing both medications might be the very best treatment for you. If both medicines are suggested with each other, your medical professional may transform the dose or exactly how often you make use of one or both of the medications.

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

Interactions with Food/Tobacco/Alcohol

Certain medications must not be made use of at or around the moment of eating food or eating particular kinds of food since communications may occur. Making use of alcohol or tobacco with specific medications might additionally trigger interactions to happen. The adhering to interactions have been chosen on the basis of their possible importance and are not necessarily all-inclusive.

Using this medication with any one of the adhering to is normally not recommended, but may be inevitable in some cases. If made use of together, your physician might transform the dosage or how usually you use this medicine, or offer you special guidelines regarding making use of food, alcohol, or tobacco.

• Ethanol
• Tobacco

Utilizing this medication with any of the adhering to may trigger an enhanced threat of specific adverse effects however might be inescapable in many cases. If made use of with each other, your physician may transform the dose or how frequently you utilize this medicine, or give you unique guidelines about making use of food, alcohol, or cigarette.

• Cabbage
• Ethanol

Other Medical Problems

The visibility of various other clinical issues may affect the use of this medication. Make certain you inform your medical professional if you have any other medical issues, especially:

• Addison's illness (adrenal gland problem) or
• Alcohol abuse, history of or
• Brain lump or
• Breathing issues (eg, persistent obstructive pulmonary condition [COPD], cor pulmonale, hypoxia, sleep apnea) or
• CNS clinical depression or
• Drug misuse or dependancy, or background of or
• Enlarged prostate or
• Head injuries or
• Hypothyroidism (underactive thyroid) or
• Increased pressure in the head or
• Mental illness, background of or
• Obesity (overweight) or
• Problems with passing pee or
• Weakened physical condition-- Use with caution. May increase risk for even more major side effects.

• Allergy to sulfites or
• Asthma-- Acetaminophen and codeine mix tablets includes salt metabisulfite, which can create allergic reactions in clients with these conditions.

• Asthma, intense or extreme or
• Respiratory anxiety (major breathing trouble) or
• Stomach or bowel obstruction (eg, paralytic ileus) or
• Surgery (eg, nasopharyngeal tonsils, tonsils)-- Should not be made use of in people with these problems.

• Kidney disease or
• Liver illness-- Use with care. The impacts might be raised as a result of slower elimination of the medicine from the body.

Together with its required impacts, a medicine might create some undesirable effects. Although not all of these negative effects might happen, if they do happen they may require medical interest.

Contact your physician instantly if any of the adhering to negative effects occur:

Extra typical

• Difficult or problem breathing
• irregular, fast or slow, or shallow breathing
• pale or blue lips, fingernails, or skin

Occurrence not understood

• Black, tarry feceses
• bleeding periodontals
• blood in the pee or stools
• coughing
• trouble with swallowing
• wooziness
• fast heartbeat
• fever with or without chills
• basic feeling of exhaustion or weak point
• hives, itching, skin rash
• hoarseness
• reduced back or side pain
• excruciating or difficult urination
• determine 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 breast
• uncommon bleeding or bruising
• unusual tiredness or weakness

Obtain emergency situation aid instantly if any one of the following signs and symptoms of overdose happen:

Symptoms of overdose

• Bloody or cloudy pee
• chills
• tightened, determine, or small pupils (black component of the eye).
• dark urine.
• frustration.
• increased sweating.
• light-colored feceses.
• anorexia nervosa.
• loss of consciousness.
• nausea or vomiting.
• seizures.
• belly pain.
• unexpected reduction in the amount of pee.
• unpleasant breath smell.
• throwing up.
• throwing up of blood.
• yellow eyes or skin.

Some negative effects may take place that typically do not need clinical focus. These adverse effects might vanish during treatment as your body gets used to the medicine. Likewise, your healthcare professional may be able to inform you about means to stop or decrease some of these negative effects. Contact your health care specialist if any of the adhering to adverse effects continue or are bothersome or if you have any inquiries regarding them:.

Much more usual.

• Drowsiness.
• faintness.
• unwinded and tranquil feeling.
• sleepiness.

Occurrence not understood.

• Difficulty having a defecation.
• incorrect or unusual feeling of health.

Opposite effects not provided might additionally occur in some patients. If you observe any kind of other effects, consult your health care specialist.

Call your physician for clinical recommendations concerning side effects. You might report adverse 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.

Readily Available Dosage Forms:.

• Elixir.
• Tablet.
• Solution.

Healing 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.