Generic Name: acetaminophen-codeine, Oral tablet

Cocet,Cocet Plus,Tylenol with Codeine No.3,Tylenol with Codeine No.4,Vopac

All Brands

  • Cocet
  • Cocet Plus
  • Tylenol with Codeine No.3
  • Tylenol with Codeine No.4
  • Vopac
SECTION 1 of 4

Highlights for acetaminophen-codeine

Oral tablet
1

Acetaminophen/codeine phosphate is an oral medication used to treat mild to moderate pain.

2

Don’t take more than 4,000 mg of acetaminophen per day. Taking more than 4,000 mg may cause severe liver problems.

3

Possible side effects include drowsiness and mental and physical slowness. Don’t perform tasks like drive a car or operate machinery while taking this medication.

4

This drug may be habit forming. Take it only as prescribed. Never share it with another person, especially someone with a history of drug misuse. Misusing this drug can result in dependence, overdose, and sometimes death.

IMPORTANT INFORMATION

FDA Warning

This drug has a Black Box Warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients to potentially dangerous effects.

May cause liver failure that can result in death or the need of a liver transplant. Most of the cases of liver injury happened when:

  • more than 4,000 mg of acetaminophen per day was taken
  • more than one acetaminophen-containing product was being taken at a time

May cause breathing problems and death in children. Codeine can cause serious breathing problems in children who took it after some surgeries, such as the removal of tonsils or adenoids. These types of surgeries in children can trigger the release of a certain enzyme that breaks down codeine faster than usual. This results in a stronger effect of the drug, which can cause these side effects.

Severe allergic reaction

Call your doctor or get emergency help right away if you have trouble breathing or develop a rash.

Sedation warning

This drug may cause drowsiness, dizziness, and mental and physical slowness. Avoid operating heavy machinery or participating in tasks that require mental alertness while taking this drug.

Alcohol warning

Avoid drinking alcohol. It can make drowsiness and dizziness worse. It may also lead to breathing problems.

Drug Features

This is a prescription drug and a controlled substance. It’s available in these forms: oral tablet, oral solution, and oral suspension. It’s available in its generic form. Generic drugs usually cost less. In some cases they may not be available in every strength or form as the brand. Talk to your healthcare provider to see if the generic will work for you.

This is a combination of two or more drugs in a single form. It is important to know about all the drugs in the combination because they each may have unique traits.

Why It's Used

Acetaminophen/codeine phosphate is used to relieve mild to moderate pain. 

How It Works

Both drugs in acetaminophen/codeine are pain relievers (analgesics), but they work differently.

More Details

How It Works

Both drugs in acetaminophen/codeine are pain relievers (analgesics), but they work differently. Acetaminophen works in the brain to block pain signals in your body. Codeine is an opioid drug, similar to morphine. Codeine breaks down into morphine in your body. It also blocks pain signals in your brain.

SECTION 2 of 4

acetaminophen-codeine Side Effects

Oral tablet

Most Common Side Effects

The most common side effects that occur with acetaminophen/codeine phosphate include:

  • nausea

  • vomiting

  • constipation

  • dizziness

  • lightheadedness

  • drowsiness

  • tiredness

  • mental or physical slowing

Serious Side Effects

If you experience any of these serious side effects, call your doctor right away. If your symptoms are potentially life threatening or if you think you’re experiencing a medical emergency, call 9-1-1.

  • allergic reaction. Symptoms may include:

    • trouble breathing
    • swelling of your throat or tongue
    • hives
  • mood changes

  • severe constipation

  • abdominal pain

  • trouble breathing or shortness of breath

  • liver injury. Symptoms may include:

    • yellowing of your skin or whites of your eyes
    • stomach pain
    • fatigue
Pharmacist's Advice
Healthline Pharmacist Editorial Team

This drug may cause drowsiness, dizziness, and mental and physical slowness. Avoid operating heavy machinery or participating in tasks that require mental alertness while taking this drug.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
SECTION 3 of 4

acetaminophen-codeine May Interact with Other Medications

Oral tablet

Acetaminophen/codeine phosphate can interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Alcohol Interaction

Avoid drinking alcohol while taking this medication. Combining the two can make the side effects of drowsiness and dizziness worse. It may increase your risk of liver damage.

Medications That Might Interact with This Drug

Drugs that reduce mental function

These include drugs that cause drowsiness. Acetaminophen/codeine may increase the effect of:

  • other narcotic pain medications
  • anesthetics used in surgery
  • medications to help you sleep

This can cause increased dizziness, drowsiness, and decreased mental and physical function. If you need to use these drugs together, the dose of one or both drugs may be lowered.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

People with head injury

If you have a head injury, codeine may increase pressure in your brain and cause an increased risk for breathing problems. The side effects caused by codeine may also decrease your ability to tell whether your head injury is getting better or worse.

People with acute abdominal conditions

Tell your doctor if you have an intestinal obstruction, constipation, or ulcerative colitis. Codeine or other narcotics can mask the signs and symptoms that are used to diagnosis and treat these conditions.

People with history of drug abuse

Codeine can be a habit-forming drug. If you have a history of drug abuse or alcohol abuse, use this drug with caution.

People with sulfite allergy

If you have a sensitivity or allergy to sulfate, this medication may cause a severe allergic reaction. This reaction may be worse if you have asthma.

People with adrenal disorders

If you have an adrenal disorder, like Addison’s disease, using this drug long term may make your disease worse. This may lead to sexual dysfunction, infertility, mood disorders, and weak bones.

People with liver or kidney disease

If you have severe liver or kidney disease, your body may not be able to remove this drug from your system fast enough. This can lead to a build up of the drug in your body and increase your risk of serious side effects. These include breathing problems and liver injury.

Pregnant women

Acetaminophen/codeine phosphate is a category C pregnancy drug. That means two things:

  1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
  2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Tell your doctor if you’re pregnant or plan to become pregnant. Newborns of  mothers who take this drug during pregnancy may have breathing problems or withdrawal symptoms. Examples of withdrawal symptoms are:

  • blotchy skin
  • diarrhea
  • excessive crying
  • fever
  • irritability
  • poor feeding
  • seizures
  • sleep problems
  • tremors
  • vomiting

This medication should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Women who are nursing

Codeine is passed into breast milk in different amounts, depending on the dose that the mother is taking. However, side effects of the drug for your baby can be fatal. Talk to your doctor about the risks of taking this drug if you plan to breastfeed.

For Seniors

If you’re older than 65 years, you may have less liver or kidney function and be more sensitive to the side effects of this drug. Your doctor may recommend a lower starting dose to avoid certain side effects.

For Children

Codeine has been associated with cases of breathing problems and death in children who took it after certain surgeries, such as tonsillectomy and adenoidectomy. This medication shouldn’t be used for pain in children who have had these types of surgeries.

Allergies

Acetaminophen/codeine phosphate can cause a severe allergic reaction. Symptoms may include:

  • trouble breathing
  • swelling of your throat or tongue
  • hives
  • rash
  • itching

If you’ve had an allergic reaction to either of the drugs in this medication, don’t take this drug. A second reaction can be fatal.

SECTION 4 of 4

How to Take acetaminophen-codeine (Dosage)

Oral tablet

All possible dosages may not be included here. Your doctor may adjust your dose according to:

  • your age
  • your health
  • other medical conditions that you have

What Are You Taking This Medication For?

Mild to moderate pain
Form: Oral Tablet, Oral Solution, Oral Suspension
Strength:
  • Oral Tablet
    • 300 mg acetaminophen/15 mg codeine phosphate
    • 300 mg acetaminophen/30 mg codeine phosphate
    • 300 mg acetaminophen/60 mg codeine phosphate
  • Oral Solution
    • 120 mg acetaminophen/12 mg codeine phosphate per 5 mL
  • Oral Suspension
    • acetaminophen 120 mg/ 12 mg codeine per 5 mL
  • Adult Dosage (ages 18 years and older)
    • Tablet: 15–30 mg of codeine and 300–600 mg of acetaminophen taken by mouth every 4 hours
    • Oral solution: 36 mg of codeine and 360 mg (15 mL) of acetaminophen taken by mouth every 4 hours as needed
    •  The maximum dosages per day for adults are:
      • 360 mg of codeine
      • 4,000 mg acetaminophen
    Child Dosage (ages 0-17 years)

    Dosages are provided for oral solution only. Tablets aren’t approved for use in children

    • (ages 12–17 years):
      • 36 mg of codeine and 360 mg (15 mL) of acetaminophen taken by mouth every 4 hours as needed
    • (ages 7–11 years):
      • 24 mg of codeine and 240 mg (10 mL) of acetaminophen taken by mouth 3–4 times per day as needed.
    • (ages 3–6 years):
      • 12 mg of codeine and 120 mg (5 mL) of acetaminophen taken by mouth 3–4 times per day as needed.
    • (ages 0–2 years):
      • Dosage for children younger than 3 years has not been established.
    • The maximum dosages per day for children aged 12–17 years are:
      • 360 mg of codeine
      • 4,000 mg of acetaminophen
    • Because no maximum daily dose of codeine has been established for children younger than 12 years, the maximum dose of acetaminophen/codeine should be determined based on the maximum dose of acetaminophen, which is: 
      • 11 years of age: 2,400 mg of acetaminophen per day
      • 9–10 years of age: 2,000 mg of acetaminophen per day
      • 6–8 years of age: 1,600 mg of acetaminophen per day  
      • 4–5 years of age: 1,200 mg of acetaminophen per day
      • 3 years of age: 800 mg of acetaminophen per day

    Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
    Pharmacist's Advice
    Healthline Pharmacist Editorial Team

    What to Do If You Miss a Dose

    This medication is usually taken as needed for pain. You may not be taking it on a schedule. If you’re taking the medication regularly, take the missed dose as soon as you can. Skip the missed dose if it’s almost time for your next scheduled dose. Don’t use extra medicine to make up a missed dose. This could result in toxic side effects.

    How to Tell if the Drug Is Working

    You may be able to tell the drug is working if you feel less pain.

    Short-Term or Long-Term Treatment

    Acetaminophen/codeine phosphate is generally used short term. However, it may be used long term, depending on the type of pain being treated.

    Take with food or milk to avoid upset stomach

    Take this medication with a full glass of water.

    Store in temperatures from 59–86°F (15–30°C)

    Don’t refrigerate the liquid forms.

    Store the medication in a container with a child-resistant closure. Keep it away from light and high temperature.

    Note: Keep your medications away from areas where they could get wet, such as bathrooms. Store them away from moisture and damp locations.

    Travel

    When traveling with your medication:

    • Always carry it with you or in your carry-on bag.
    • Airport X-ray machines can’t hurt this medication.
    • You may need to show your pharmacy’s preprinted label to identify the medication. Keep the original prescription-labeled bottle with you when traveling.
    • Since this is a controlled substance, you may not have refills from your doctor. Be sure to check that you have enough medication before you leave on your trip.

    Clinical Monitoring

    Your doctor may check your liver and kidneys function if you have liver or kidney disease.

    To make sure the drug is working and to manage any side effects, your doctor may monitor for the following:

    • decrease in pain and improvement in your ability to move
    • your ability to have bowel movements
    • changes in your mood
    • lung function or breathing problems
    • symptoms of withdrawal

    Are There Any Alternatives?

    There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.


    Show Sources

    Content developed in collaboration with Akanksha Patel (UIC)

    Medically reviewed by Philip Gregory, PharmD, MS, FACN on April 8, 2015

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    Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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