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?
Tylenol No. 1® is no longer being manufactured for sale in Canada. For brands that may still be available, search under acetaminophen - codeine - caffeine. This article is being kept available for reference purposes only. If you are using this medication, speak with your doctor or pharmacist for information about your treatment options.
How should I use this medication?
The usual recommended dose 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 (or a maximum of 4,000 mg of acetaminophen) in a 24-hour period may cause severe liver damage, and could be fatal.
This medication may be taken with or without food. Tablets should be swallowed whole. Do not cut, break, crush, chew, or dissolve the tablets, as this may lead to dangerous and potentially fatal side effects.
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 acetaminophen, caffeine, codeine, or any ingredients of the medication
- are overdosed on or intoxicated by alcohol, hypnotics, analgesics, or psychotropic medications
- have mild pain that can be managed with other pain medications
- are 12 years of age or younger
- are 18 years of age or younger and are having or have recently had surgery for removal tonsils or adenoids
- are experiencing acute asthma or other obstructive airway disease
- are experiencing acute respiratory depression
- are taking a monoamine oxidase (MAO) inhibitor (e.g., phenelzine, tranylcypromine) or have taken one in the last 14 days
- 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 a suspected abdominal condition that may require surgery
- have severely reduced liver or kidney function
- are a known CYP2D6 ultra-rapid metabolizer (someone who converts codeine into its active metabolite more rapidly and completely)
- are pregnant or breast-feeding, in labour, or delivering
Non-prescription medications containing codeine should not be used for people under 18 years old.
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.
- decreased ability or interest in sexual activity
- decreased appetite
- dry mouth
- trouble sleeping
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
- dizziness when rising from a lying down or sitting position
- fast, slow, or irregular heartbeat
- mood changes
- restlessnessskin rash
- vision problems
- weakness or difficulty with muscle coordination
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 breathing problems (e.g., shortness of breath, wheezing, irregular or troubled breathing)
- 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
- symptoms of a bowel blockage (e.g., abdominal pain, severe constipation, nausea)
- symptoms of overdose (e.g., cold, clammy skin; abnormally slow or weak breathing; severe dizziness; confusion; slow heartbeat; or extreme drowsiness)
- symptoms of serotonin syndrome (e.g., agitation or restlessness, loss of muscle control, muscle twitching, tremor, diarrhea)
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 31, 2020
Health Canada has issued new information concerning the use of non-prescription pain relief products containing codeine. 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.
Accidental use: Accidental ingestion or use of this medication by someone for whom it has not been prescribed can lead to a fatal overdose. Children are especially at risk. Keep this medication out of sight and reach of children.
Alcohol and other medications that cause drowsiness: Do not combine this medication with alcohol or other medications (e.g., antidepressants, sleeping pills, anxiety medications) that cause drowsiness since additional drowsiness or suppressed breathing can occur and be dangerous and possibly life-threatening.
Breathing: Codeine can suppress breathing. If you are at risk for breathing difficulties (e.g., if you have asthma or chronic lung 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.
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.
Low blood pressure: Codeine may cause low blood pressure or make low blood pressure worse. If you experience severe dizziness, especially when standing from a lying or sitting position, contact your doctor.
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.
Ultra-rapid codeine metabolizers: Some people process codeine faster and more completely than others due to a genetic variation. This can result in higher-than-expected drug levels in the body, which may result in overdose symptoms and serious or life-threatening effects on breathing. If you are known to be a rapid metabolizer of codeine you should avoid using this medication.
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.
Serotonin syndrome: Although rare, severe reactions are possible when codeine is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors (medications used to treat depression). Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, or changes in mental state including delirium and agitation. Coma and death are possible.
If you are taking antidepressants, 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. Infants born to mothers who have been taking codeine for long periods of time may experience dangerous withdrawal symptoms at birth.
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 at risk of receiving a morphine overdose through the breast milk. If you are breast-feeding 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 old. Medications containing codeine should not be given to people under 18 years old for pain management after surgery to remove the tonsils and or adenoids.
Non-prescription products containing codeine should not be used by people under 18 years old. Recent evidence shows that young people who use opioids, including codeine, may be more likely to have problems with the misuse of medications and other substances later in life.
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:
- abiraterone acetate
- amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
- antihistamines (e.g., cetirizine, diphenhydramine, hydroxyzine, loratadine)
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- azole antifungals (e.g. fluconazole, ketoconazole, voriconazole)
- barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
- benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
- chloral hydrate
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- general anaesthetics (medications used to put people to sleep before surgery)
- grapefruit juice
- HIV protease inhibitors (e.g., atazanavir, darunavir, lopinavir, ritonavir)
- kava kava
- lumacaftor and ivacaftor
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- magnesium sulfatemethadone
- methylene blue
- monoamine oxidase (MAO) inhibitors (e.g., moclobemide, phenelzine, selegiline, tranylcypromine)
- muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
- other narcotic pain relievers (e.g., fentanyl, hydrocodone, morphine)
- other products containing acetaminophen, caffeine, or codeine
- St. John's wort
- seizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
- serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
- somatostatin analogs (e.g., lanreotide, octreotide, pasireotide)
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
- "triptan" migraine medications (e.g., rizatriptan, sumatriptan)
- tyrosine kinase inhibitors (e.g., dasatinib, imatinib, nilotinib)
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 – 2021. 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-1