How does this medication work? What will it do for me?
This combination product contains three medications: acetaminophen, codeine, and caffeine.
Acetaminophen belongs to the group of medications called analgesics (pain relievers) and antipyretics (fever reducers).
Codeine belongs to the group of medications called narcotic analgesics.
Caffeine belongs to the group of medications called stimulants.
This combination of medications is used to treat mild-to-moderate pain associated with conditions such as headache, dental pain, muscle pain, painful menstruation, pain following an accident, and pain following operations.
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 hard, white, capsule-shaped tablet, imprinted with stylized "M" and "McNEIL" on one face and "No. 1" on the other, contains acetaminophen 300 mg, caffeine 15 mg, and codeine phosphate 8 mg. Nonmedicinal ingredients: cellulose, cornstarch, magnesium stearate, and sodium starch glycolate. This medication does not contain gluten, lactose, sodium metabisulfite, or tartrazine.
How should I use this medication?
The usual recommended dose for people older than 12 years of age is 1 tablet taken every 4 to 6 hours as required. If 1 tablet is not effective, take 2 tablets at the next dose time. The dose should be adjusted according to the amount of pain experienced. The maximum dose of this medication is 12 tablets in 24 hours. Taking more than 12 tablets in a 24 hour period may cause severe liver damage, and could be fatal.
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.
Acetaminophen should not be taken to relieve pain for more than 5 days or to relieve a fever for more than 3 days, unless directed by a doctor.
It is important to take this medication exactly as prescribed by your doctor. If your doctor has told you to take this medication on a regular basis and you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of 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 to acetaminophen, caffeine, codeine, or any ingredients of the medication
- are overdosed on or intoxicated by alcohol, hypnotics, analgesics, or psychotropic medications
- are 12 years of age or younger
- are experiencing acute asthma or other obstructive airway disease
- are experiencing acute respiratory depression
- have a blockage of the gastrointestinal tract, particularly paralytic ileus
- have a head injury, a brain tumour, or increased pressure inside the head or spinal cord
- have a convulsive (seizure) disorder
- have suspected abdominal conditions that may require surgery
- are pregnant or breast-feeding, in labour, or delivering
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.
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- abdominal pain
- mood changes
- shortness of breath
- signs of breathing problems (e.g., shortness of breath, wheezing, irregular or troubled breathing)
- skin rash
- stomach upset
- trouble sleeping
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a serious allergic reaction (i.e., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
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
July 9, 2015
Health Canada has issued new restrictions concerning the use of acetaminophen. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
June 6, 2013
Health Canada has issued new restrictions concerning the use of codeine and codeine-containing products. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Abdominal conditions: Codeine may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have an abdominal condition 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.
Alcohol use: If you regularly drink large amounts of alcohol, talk to your doctor about the increased risk for liver damage related to the acetaminophen component of this medication and how to use this medication safely.
Constipation: Codeine can be very constipating. Eating a high-fibre diet and following good bowel habits will help to minimize this effect. If you develop constipation easily, 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 and withdrawal: This medication contains codeine. Physical dependence, psychological dependence, and abuse have occurred with the use of codeine. 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.
If you suddenly stop taking this medication, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shaking, pain, nausea, tremors, diarrhea, and hallucinations. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor.
Drowsiness/reduced alertness: This medication may cause drowsiness. Do not drive, operate machinery, or perform other potentially hazardous tasks until you have determined how this medication affects you.
Head injury: If you have a head injury or increased pressure in the head, you may have a higher risk of experiencing side effects (breathing problems) or worsening of your condition while taking this medication. 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 kidney disease or reduced kidney function, 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: Acetaminophen can cause decreased liver function. If you have liver disease or reduced liver function, 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. Taking too much acetaminophen with codeine may cause liver problems.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Other medical conditions: If you are about to undergo surgery of the biliary tract, approach taking codeine with caution, as it may worsen your condition. Codeine will worsen the effects of acute alcohol intoxication and delirium tremens.
As well, if you have low thyroid (hypothyroidism), Addison's disease, benign prostatic hypertrophy (enlarged prostate), gallbladder disease, urethral stricture, decreased function of the adrenal glands, or porphyria, 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.
Worsening symptoms: If redness or swelling occurs in the area of pain, if symptoms do not improve or they worsen, or if new symptoms develop (e.g., high fever, rash, itching, persistent headache) while you are taking this medication, contact your doctor as soon as possible. These may be signs of other conditions that require medical attention.
Seizures: This medication may cause seizures. Seizures are more likely to occur when higher doses of this medication are taken. If you have a history of epilepsy or medical conditions that increase the risk of seizures, 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.
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, codeine, and caffeine pass into breast milk. Some of the codeine dose is converted into morphine by the body, once it has been taken. For some people, this change happens much faster than for others. If this happens to a nursing mother, the baby is a risk of receiving a morphine overdose through the breast milk.
If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children under 12 years of age.
Seniors: Seniors who take this medication may be more likely to experience side effects or worsening of preexisting medical conditions.
What other drugs could interact with this medication?
There may be an interaction between acetaminophen - codeine - caffeine and any of the following:
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