How does this medication work? What will it do for me?
This combination product contains two medications: acetaminophen and codeine. Acetaminophen belongs to the group of medications called analgesics (pain relievers) and antipyretics (fever reducers). Codeine belongs to the family of medications known as opioid analgesics (narcotic pain relievers). This medication is used to relieve moderate to severe pain.
Codeine works by acting on the central nervous system to block pain signals, increasing the ability to tolerate pain. Acetaminophen works by raising your pain threshold.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each round, hard, white tablet, flat-faced, bevelled, engraved with "4" on one side and flat-faced special design, bevelled, engraved with "McNEIL" on the other side, contains acetaminophen 300 mg and codeine phosphate 60 mg. Nonmedicinal ingredients: cellulose, cornstarch, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate, and talc. This medication does not contain gluten, lactose, sodium metabisulfite, or tartrazine.
How should I use this medication?
Acetaminophen with codeine comes in a variety of different strengths and dosage forms. Dosing depends on the strength and dosage form being used.
Tablets: The recommended adult dose is 1 tablet every 4 to 6 hours as needed for pain. No more than 6 tablets should be taken in a 24 hour period.
Liquid: The recommended adult dose is 10 mL to 20 mL every 4 hours as needed for pain. No more than 5 doses should be taken in a 24 hour period. For children, the recommended dose is based on body weight and is given every 4 hours as needed for pain.
Use an oral syringe to measure each dose of the liquid, as it gives a more accurate measurement than household teaspoons.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
The dose limits for the single and 24-hour dose, as well as the time interval between doses, should be followed strictly as recommended by your doctor. This medication may be habit-forming if taken for long periods of time. If you have been taking this medication for a long period of time, do not stop taking this medication without talking with your doctor. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shakiness, nausea, tremors, diarrhea, or hallucinations. If you plan on stopping the medication, your doctor may want you to reduce the dose gradually to reduce the severity of withdrawal effects.
It is important to take this medication exactly as prescribed by your doctor.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you are:
- allergic to acetaminophen, codeine, or any ingredients of the medication
- 12 years of age or younger
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- blurred or double-vision (or other changes in vision)
- dry mouth
- false sense of well-being
- general feeling of discomfort or illness
- lightheadedness or feeling faint
- loss of appetite
- nervousness or restlessness
- nightmares or unusual dreams
- unusual tiredness or weakness
Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- black, tarry stools
- fast, slow, or pounding heartbeat
- increased sweating
- irregular breathing or wheezing
- mental depression
- pain in lower back or side (that is severe or sharp)
- pinpoint-sized red spots on skin
- redness or flushing of face
- ringing or buzzing in ears
- signs of an allergic reaction such as hives, itching, or skin rash
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- symptoms of urinary retention such as decrease in amount of urine, or difficult or painful urination
- sore throat and fever
- swelling of face
- trembling or uncontrolled muscle movements
- unusual bleeding or bruising
- unusual excitement (especially in children)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- convulsions (seizures)
- signs of breathing problems such as shallow, irregular breathing, or slow or troubled breathing)
- signs of a serious allergic reaction (i.e., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- symptoms of overdose such as cold, clammy skin, abnormally slow or weak breathing, severe dizziness, confusion, slow heartbeat, or extreme drowsiness
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
August 24, 2020
Health Canada has issued new restrictions concerning the use of acetaminophen - codeine. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Previous advisories on acetaminophen - codeine were issued on September 15, 2016, July 28, 2016, July 9, 2015 and June 6, 2013.
Abdominal conditions: Codeine may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have any abdominal conditions such as inflammatory or obstructive bowel disease, acute cholecystitis, or pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Alcoholism: People who drink large amounts of alcohol over long periods of time and who take this medication should be closely monitored by their doctors. These people are at increased risk of liver damage or disease.
Breathing: Codeine can suppress breathing. If you are at risk for breathing difficulties (e.g., if you have asthma), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Dependence: After prolonged use, codeine can produce psychological dependence (a psychological "need" for the medication that is not related to the physical need; this is rare), physical dependence (stopping the medication abruptly may lead to withdrawal symptoms), or tolerance (the need to take higher doses to get the same effect). People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication. Abuse is not a problem with people who require this medication for pain relief. Talk to your doctor if you have any concerns about dependence.
Drowsiness/reduced alertness: Acetaminophen - codeine may impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. You should avoid such activities until you are certain this medication does not have this effect on you.
Head injury: People with head injuries or increased pressure in the head may have a higher risk of experiencing side effects (breathing problems) or worsening of their condition while taking this medication. If you have had a recent head injury, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Kidney function: If you have severely reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: If you have severely reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Other medical conditions: If you have hypothyroidism, Addison's disease, enlarged prostate (BPH; benign prostatic hypertrophy), or narrowing of the urethra, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Seizures: This medication may cause seizures, especially when higher doses are used or when taken with other medications that may increase the risk of seizures such as:
- monoamine oxidase inhibitors (MAOIs; e.g., phenelzine, tranylcypromine)
- neuroleptics (e.g., haloperidol, quetiapine, olanzapine, risperidone)
- opioids (e.g., fentanyl, morphine, oxycodone)
- selective serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, fluoxetine, citalopram)
- tricyclic antidepressants (TCAs; e.g., amitriptyline, imipramine)
The risk of seizures is also higher for people with epilepsy, a history of seizures, or who are at risk of seizures (e.g., people with head trauma).
Pregnancy: Dependence and withdrawal signs have been reported in newborns whose mothers took medications such as acetaminophen - codeine regularly during pregnancy. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: Acetaminophen and codeine pass into breast milk. Babies who are breast-fed by mothers who metabolize codeine very quickly may be at increased risk for codeine overdose because there may be higher-than-expected levels of codeine in breast milk. The safety of this medication has not been established for use by breast-feeding mothers and is not recommended for use while breast-feeding.
Children: The tablet and caplet form of this medication should not be given to children less than 12 years of age. The liquid form of the medication should not be given to children under 2 years of age.
Seniors: Seniors may be more sensitive to the side effects of this medication.
What other drugs could interact with this medication?
There may be an interaction between acetaminophen - codeine and any of the following:
- amphetamines (e.g., dextroamphetamine)
- antianxiety medications (e.g., diazepam, lorazepam)
- anticholinergics (e.g., atropine, ipratropium)
- antihistamines (e.g., diphenhydramine, doxylamine, hydroxyzine)
- antipsychotics (e.g., haloperidol, quetiapine, risperidone, trifluoroperazine)
- barbiturates (e.g., phenobarbital)
- MAO inhibitors (e.g., tranylcypromine, phenelzine)
- other narcotic analgesics (e.g., fentanyl, morphine, oxycodone)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
- thiazide diuretics (water pills; e.g., hydrochlorothiazide, indapamide)
- tricyclic antidepressants (e.g., amitriptyline, imipramine)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2023. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Tylenol-No-4-with-Codeine