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Tylenol w/Codeine #4

Pronunciation

Generic Name: acetaminophen and codeine (Oral route)

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

Oral route(Tablet)

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 mg/day, and often involve more than one acetaminophen-containing product. Respiratory depression and death have occurred in pediatric patients who received codeine after tonsillectomy, adenoidectomy, or both. These patients had evidence of being ultrarapid metabolizers of codeine due to a CYP2D6 polymorphism .

Commonly used brand name(s)

In the U.S.

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

Available Dosage Forms:

  • Tablet
  • Capsule
  • Elixir
  • Suspension
  • Solution

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Codeine

Uses For Tylenol w/Codeine #4

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

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

Slideshow: The Shocking Truth About Antibiotic Resistance

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 when it is used for a long time or in large doses. Physical dependence may lead to withdrawal side effects when you stop taking the medicine. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

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

Before Using Tylenol w/Codeine #4

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

Allergies

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

Pediatric

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

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

Tylenol® with codeine should not be used to relieve pain after surgery to remove tonsils and/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 in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving acetaminophen and codeine.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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.

  • Naltrexone

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

  • Alfentanil
  • Alprazolam
  • Anileridine
  • Baclofen
  • Bromazepam
  • Buprenorphine
  • Bupropion
  • Butalbital
  • Butorphanol
  • Carbinoxamine
  • Carisoprodol
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorzoxazone
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Codeine
  • Dantrolene
  • Dezocine
  • Diazepam
  • Estazolam
  • Ethchlorvynol
  • Fentanyl
  • Flunitrazepam
  • Fluoxetine
  • Flurazepam
  • Halazepam
  • Hydrocodone
  • Hydromorphone
  • Imatinib
  • Ketazolam
  • Levorphanol
  • Lorazepam
  • Lormetazepam
  • Meclizine
  • Medazepam
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Metaxalone
  • Methocarbamol
  • Methohexital
  • Midazolam
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Nitrazepam
  • Opium
  • Orphenadrine
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Pentazocine
  • Pixantrone
  • Prazepam
  • Propoxyphene
  • Quazepam
  • Remifentanil
  • Sodium Oxybate
  • Sufentanil
  • Tapentadol
  • Temazepam
  • Thiopental
  • Tizanidine
  • Triazolam

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

  • Acenocoumarol
  • Carbamazepine
  • Fosphenytoin
  • Isoniazid
  • Lixisenatide
  • Perampanel
  • 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

Other Medical Problems

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

  • Addison's disease (adrenal gland problem) or
  • Alcohol abuse, history of or
  • Breathing problems (eg, chronic obstructive pulmonary disease [COPD], cor pulmonale, hypoxia, sleep apnea, respiratory depression) or
  • CNS depression or
  • Drug abuse or dependence, or history of or
  • Enlarged prostate or
  • Hypothyroidism (underactive thyroid) or
  • Problems with passing urine or
  • Weakened physical condition—Use with caution. May increase risk for more serious side effects.
  • Allergy to sulfites or
  • Asthma—Tylenol® with codeine tablets contains sodium metabisulfite, which can cause allergic reactions in patients with these conditions.
  • Brain tumor or
  • Head injuries or
  • Increased pressure in the head—Some of the side effects of codeine can cause serious problems in people who have these medical problems.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Stomach or digestion problems—This medicine may mask the diagnosis of these conditions.
  • Surgery (eg, nasopharyngeal tonsils, tonsils)—Should not be used in patients with this condition.

Proper Use of acetaminophen and codeine

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

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

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 oral dosage form (suspension):
    • For mild to moderate pain:
      • 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):
    • For mild to moderately severe pain:
      • 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.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using Tylenol w/Codeine #4

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

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.

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.

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.

If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a 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 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. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop using this medicine and call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

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

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

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.

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 troubled breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

Tylenol w/Codeine #4 Side Effects

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

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

More common
  • Difficult or troubled breathing
  • irregular, fast or slow, or shallow breathing
  • pale or blue lips, fingernails, or skin
  • shortness of breath
Incidence not known
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • cough or hoarseness
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fever with or without chills
  • general feeling of tiredness or weakness
  • hives
  • itching
  • lower back or side pain
  • painful or difficult urination
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • tightness in the chest
  • unusual bleeding or bruising
  • unusual tiredness or weakness

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

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

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

More common
  • Drowsiness
  • lightheadedness
  • relaxed and calm
  • sleepiness
Incidence not known
  • Difficulty having a bowel movement (stool)
  • false or unusual sense of well-being

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

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

See also: Side effects (in more detail)

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