Tylenol and Codeine

Acetaminophen/codeine is a prescription medication used to treat mild to moderately severe pain. It is a single medication containing two drugs, acetaminophen and codeine. Acetaminophen/codeine belongs to a group of drugs called analgesics, which helps stop the spread of pain signals from the brain to the body.

This medication comes in tablet and oral (by mouth) solution forms and may be taken up to 6 times a day as needed, with or without food.

Common side effects of acetaminophen/codeine include dizziness, lightheadedness, and shortness of breath.

Acetaminophen/codeine can also cause drowsiness. Do not drive or operate heavy machinery until you know how this medication will affect you. Alcohol may intensify this side effect.

Acetaminophen/codeine may result in physical dependence and is a high-risk medication for abuse.

Acetaminophen/codeine is a prescription medication used to treat mild to moderately severe pain.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Janssen Pharmaceutical, Inc.

Serious side effects have been reported with acetaminophen/codeine. See "Drug Precautions" section.

Common side effects of acetaminophen/codeine include:

• dizziness
• lightheadedness
• shortness of breath
• drowsiness
• nausea
• vomiting
• constipation

This is not a complete list of acetaminophen/codeine side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take or use:

• alcohol
• tranquilizers such as chlordiazepoxide
• general anesthetics such as phenobarbital (Donnatal), alprazolam (Xanax), and clonazepam (Klonopin)
• central nervous system (CNS) depressants such as zolpidem (Ambien) or eszopiclone (Lunesta)
• other narcotic analgesics such as morphine (MS Contin), oxycodone (Oxycontin), or methadone (Dolophine)
• other medications containing acetaminophen
• antidepressants such as fluoxetine (Prozac, Sarafem), venlafaxine (Effexor), or citalopram (Celexa)

This is not a complete list of acetaminophen/codeine drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with acetaminophen/codeine including:

• liver toxicity. This may occur with excessive use of acetaminophen (greater than 4 grams per day or with alcohol use/abuse). Tell your healthcare provider right away if you have some or all of the following symptoms of liver toxicity:
  • diaphoresis (abnormally high amount of sweating)
  • general malaise (feeling of discomfort)
  • nausea
  • vomiting
• hypersensitivity/anaphylaxis (allergic reaction). Tell your healthcare provider right away if you have some or all of the following symptoms of hypersensitivity/anaphylaxis:

• face, mouth, or throat swelling
• breathing problems
• urticaria (red itching spots on skin)
• rash
• itching skin
• vomiting

• increased tolerance and physical dependence. Acetaminophen/codeine is also a high-risk medication for addiction.
  • Tolerance - the need for increasing doses of this medication to maintain pain relief (without signs of worsening disease)
  • Physical dependence - when withdrawal symptoms occur after suddenly stopping this medication
  • Addiction - abnormal or compulsive use of substance for non-medical needs

• respiratory depression. Tell your healthcare provider right away if you have difficulty of breathing while taking this medication. Alcohol may intensify this side effect.
• ultra-rapid metabolizers. Some individuals convert codeine into its active form, morphine, more rapidly and completely than other people.
  • This results in higher-than-expected morphine levels.
  • Even at recommended doses, these patients may experience overdose symptoms such as extreme sleepiness, confusion, or shallow breathing.
• serious skin reactions. Symptoms may include skin reddening, rash, blisters, and the upper surface of the skin may become separated from the lower layers. This can occur even if you have taken acetaminophen in the past without any problems. If you develop any skin rash or reaction while using a medication containing acetaminophen, including this medication, stop the medication and seek medical attention immediately. If you have had a serious skin reaction with acetaminophen, do not take it or any products containing acetaminophen again. Doing so could cause you to have another serious skin reaction.

Acetaminophen/codeine can cause dizziness. Do not drive or operate heavy machinery until you know how acetaminophen/codeine affects you. Alcohol may intensify this side effect.

Do not take acetaminophen/codeine if you are allergic to acetaminophen, codeine, sulfite, or to any other ingredients within this medication.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of acetaminophen/codeine, there are no specific foods that you must exclude from your diet when receiving acetaminophen/codeine.

Alcohol may intensify some of the side effects of this medication.

Before taking digoxin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have or have had liver disease
• have or have had kidney disease
• have or have had a head injury
• have or have had stomach or bowel (intestinal) problems
• have a history of alcohol or drug use, dependence, or abuse
• have a history of lung or thyroid disease
• have a history or urethral stricture, or narrowing of the urethra (tube that carries urine out of the body)
• have or will soon have surgery
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Acetaminophen/codeine falls into category C. This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

It is not known if acetaminophen/codeine will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

The active ingredient in acetaminophen/codeine is excreted in human breast milk. The effect of acetaminophen/codeine on the nursing infant is not known.

Mothers using codeine should be told about when to seek immediate medical care and how to identify the signs and symptoms of infant toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby.

Take acetaminophen/codeine exactly as prescribed.

Acetaminophen/codeine comes in tablet and oral (by mouth) solution forms.

Acetaminophen/codeine is usually taken up to 6 times a day as needed for pain.

It can be taken with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of acetaminophen/codeine at the same time.

Take acetaminophen/codeine exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Dosing is determined by amount of pain and a patient's response to the medication. Maximum dosage should not exceed 4 grams (4000 mg) of acetaminophen.

If you take too much acetaminophen/codeine, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store acetaminophen/codeine at room temperature.
• Shake suspension well before use.
• Keep this and all medicines out of the reach of children.

Hepatotoxicity:

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams (4 grams) per day, and often involve more than one acetaminophen-containing product.