acetaminophen and codeine

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Pronunciation: a SEET a MIN o fen and KOE deen

Brand: Capital and Codeine Suspension, Tylenol with Codeine #3, Tylenol with Codeine #4

Acetaminophen-Codeine 300 mg-15 mg-MAL

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Acetaminophen-Codeine 300 mg-30 mg-MAL

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Acetaminophen-Codeine 300 mg-30 mg-RAN

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Acetaminophen-Codeine 300 mg-60 mg-MAL

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Acetaminophen-Codeine 300 mg-60 mg-RAN

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APAP 2-BAR

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APAP 2-TEV

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APAP 3-BAR

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APAP 3-QUA

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APAP 3-TEV

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APAP 4-BAR

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APAP 4-TEV

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Tylenol 3

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What is the most important information I should know about acetaminophen and codeine?

You should not use this medicine if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

What is acetaminophen and codeine?

Codeine is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of codeine.

Acetaminophen and codeine is a combination medicine used to relieve moderate to severe pain.

Acetaminophen and codeine may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking acetaminophen and codeine?

You should not use this medicine if you are allergic to acetaminophen or codeine, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Codeine may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Selling or giving away this medicine is against the law.

Some medicines can interact with codeine and cause a serious condition called serotonin syndrome, especially medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or nausea. Ask your doctor before making any changes in how or when you take your medications.

To make sure acetaminophen and codeine is safe for you, tell your doctor if you have:

  • liver disease, cirrhosis, or if you drink more than 3 alcoholic beverages per day;
  • a history of alcoholism or drug addiction;
  • diarrhea, inflammatory bowel disease, bowel obstruction, severe constipation;
  • kidney disease;
  • a history of head injury, brain tumor, or stroke; or
  • asthma, COPD, sleep apnea, or other breathing disorders.

Codeine is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

If you use this medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not breast-feed while taking this medicine.

How should I take acetaminophen and codeine?

Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and codeine. Do not use a stool softener (laxative) without first asking your doctor.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time that you are using this medicine.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using acetaminophen and codeine.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medicine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and codeine can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include extreme drowsiness, pinpoint pupils, confusion, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while taking acetaminophen and codeine?

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

What are the possible side effects of acetaminophen and codeine?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Seek emergency medical attention if a child taking this medication has any of the following life-threatening side effects: noisy breathing, sighing, slow breathing with long pauses between breaths; being unusually sleepy or hard to wake up; blue colored lips.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Call your doctor at once if you have:

  • shallow breathing, slow heartbeat;
  • a light-headed feeling, like you might pass out;
  • confusion, unusual thoughts or behavior;
  • seizure (convulsions);
  • infertility, missed menstrual periods, impotence, sexual problems, loss of interest in sex;
  • easy bruising or bleeding;
  • liver problems --nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • low cortisol levels --nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects include:

  • drowsiness;
  • upset stomach, constipation;
  • blurred vision; or
  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect acetaminophen and codeine?

Some medicines can cause unwanted or dangerous effects when used with acetaminophen and codeine. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking acetaminophen and codeine with a sleeping pill, muscle relaxer, other pain medicine, or medicine for anxiety, depression, or seizures.

Other drugs may interact with acetaminophen and codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about acetaminophen and codeine.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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