This combination product contains 4 medications: acetylsalicylic acid (ASA), butalbital, caffeine, and codeine.

ASA belongs to the group of medications called analgesics (pain relievers), anti-inflammatories, and antipyretics (fever reducers).

Butalbital belongs to the group of medications called barbiturates, and is a relaxant.

Codeine belongs to the group of medications called narcotic analgesics.

Caffeine belongs to the group of medications called stimulants.

This medication is used for the relief of headache pain that is accompanied by tension or anxiety. 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.

The recommended adult dose is 1 or 2 capsules at once followed by 1 capsule every 4 to 6 hours as necessary, to a maximum of 6 capsules in one day. The lowest effective dose of this medication should be taken for the shortest period of times possible. Swallow the capsules whole with water. Do not crush, chew, or open the capsules.

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.

This medication may be habit-forming if taken for long periods of time. It can abused and should be taken only as needed for pain unless otherwise directed by your doctor. If this medication has been taken for a prolonged length of time and 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 this medication, your doctor may want you to reduce the dose gradually to lessen the severity of withdrawal effects.

It is very important to use this medication exactly as prescribed by your doctor. This medication should be avoided in situations where pain medication is required on a daily basis.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not use this medication if you:

• are allergic to ASA, caffeine, codeine, butalbital, or any ingredients of the medication
• are experiencing an asthma attack
• are pregnant or breast-feeding
• are in labour (giving birth)
• have a history of blood clotting problems
• have a seizure disorder or a history of seizures
• have a history of breathing problems after taking ASA or other anti-inflammatory medications
• have a condition that slows down passage of material through the digestive tract
• have or may have appendicitis or pancreatitis
• have mild pain that can be treated with other medications
• have acute asthma or other obstructive airway diseases (e.g., chronic bronchitis, emphysema)
• have active alcoholism or are experiencing alcohol withdrawal
• are taking an MAO inhibitor (e.g., phenelzine, tranylcypromine) or have taken one in the past 2 weeks
• have porphyria (a condition of the liver)
• have pre-existing respiratory depression
• have stomach ulcers or duodenal ulcers
• have a history of abuse or intoxication with alcohol, hypnotics, analgesics, or psychotropic drugs

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.

• abdominal pain
• constipation
• decreased appetite
• decreased sexual ability or interest in sexual activity
• dizziness
• drowsiness (mild)
• dry mouth
• gas
• itching
• headache
• heartburn
• lightheadedness
• nausea
• skin rash
• trouble sleeping
• vomiting
• weakness

Although most of these 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:

• confusion
• decreased coordination
• difficulty thinking, concentrating
• dizziness or lightheadedness when rising from a sitting or lying position
• exaggerated persona
• fast or irregular heartbeat
• feeling "drunk" or intoxicated
• feeling faint
• irritability
• mood swings
• poor memory and judgement
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up blood, vomiting blood or material that looks like coffee grounds)
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of decreased kidney function (e.g., difficulty or pain urinating, frequent urge to urinate, decrease in amount of urine)
• tremor
• vision problems

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of breathing problems such as shallow, irregular breathing, or slow 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 codeine overdose, such as abnormally slow or weak breathing, cold and clammy skin, extreme drowsiness, severe dizziness and confusion, and slow heartbeat
• symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)

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.

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.

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: When this medication is used by anyone other than the person for whom it was prescribed, the effects of the medication may be fatal. Children are especially at risk. Keep this medication out of sight and reach of children.

Alcohol and other medications that cause drowsiness: Do not consume alcohol while taking this medication, as this may lead to dangerous and even fatal side effects. Other medications that cause drowsiness or slow down your breathing (e.g., antidepressants, sleeping pills, anxiety medications) should be avoided if possible, as additive side effect may occur and can be dangerous and possibly fatal.

Adrenal gland problems: People who take opioid medications, such as codeine, for more than 1 month may experience symptoms of decreased adrenal gland function. The adrenal gland produces certain hormones that keep the body functioning normally. If you experience nausea or vomiting, decreased appetite, and feelings of tiredness, weakness, or dizziness, talk to your doctor.

Allergy: Some people who are allergic to other anti-inflammatory medications or those who have nasal polyps or asthma also experience allergic reactions to ASA. Before you take ASA - caffeine - codeine - butalbital, inform your doctor about any previous adverse reactions you have had to medications, especially non-steroidal anti-inflammatory medications or narcotic medications. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing or swelling of the face and throat.

Bleeding disorders: ASA may increase bruising and bleeding from cuts that may take longer to stop. If you have a bleeding disorder or a history of bleeding problems, 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.

Breathing: Codeine and butalbital can suppress breathing. If you are at risk for breathing difficulties, such as 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.

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 and butalbital. Physical dependence, psychological dependence, and abuse have occurred with the use of both these medications. 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.

If you have been taking this medication regularly and suddenly stop taking it, 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 their 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: Taking ASA - caffeine - codeine - butalbital over a long period of time may increase the risk of developing kidney disease. 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: 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.

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.

Medication overuse headaches: When medications are taken regularly for some types of headaches, medication overuse headaches may develop. These are sometimes called "rebound headaches." The symptoms of the headache return as the effects of the medication wear off. This is a symptom of the body "withdrawing" from the medication, a result of taking the medication too frequently. If you experience more headaches than usual or notice that the headache regularly returns after 8 hours, contact your doctor.

Stomach problems: ASA may cause stomach problems such as ulcers or bleeding. If you have a stomach problem, 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. Call your doctor immediately if you notice signs such as stomach or abdominal pain, black tarry stools, or vomiting blood. Using ASA at the same time as other anti-inflammatory medications increases the risk of stomach ulcers and bleeding.

Surgery: ASA may cause increased bleeding during surgery. If you are scheduled for surgery, let your doctor know that you are taking this medication. Talk to your doctor or dentist about whether you should take this medication within the 5 to 7 days before any surgery.

Pregnancy: This medication is not recommended for use by pregnant people unless the anticipated benefits outweigh the possible risks. Use of this medication can harm a developing baby, as well as cause serious withdrawal symptoms in newborns. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: ASA - caffeine - codeine - butalbital passes 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, which could be fatal. This medication should not be used by breast-feeding mothers.

Children: The safety and effectiveness of using this medication have not been established for children under the age of 18 years.

The use of ASA may be associated with the development of Reye's syndrome in children and teenagers who have illnesses accompanied by fever, especially influenza and chickenpox. ASA should not be given to, or used by, children or teenagers who have chickenpox or flu symptoms unless a doctor is consulted.

Children are especially susceptible to an overdose of caffeine and its side effects on the central nervous system.

ASA is one of the most frequent causes of accidental poisoning in toddlers and infants. Medications that contain ASA should be kept out of the reach of all children.

Seniors: Seniors may be more susceptible to the harmful effects of the medicines in this product.

There may be an interaction between ASA - caffeine - codeine - butalbital and any of the following:

• abiraterone
• acetazolamide
• acetylsalicylic acid (ASA)
• aclidinium
• alcohol
• alendronate
• aliskiren
• alpha agonists (e.g., clonidine, guanfacine, methyldopa)
• alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• anagrelide
• anesthetics (medications used to put people to sleep before surgery)
• angiotensin converting enzyme inhibitors (ACEIs; e.g., captopril, ramipril)
• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
• antiarrhythmics (e.g., amiodarone, disopyramide, dronedarone, mexiletine)
• antihistamines (e.g., azelastine, cetirizine, dimenhydrinate, diphenhydramine, hydroxyzine)
• antimalarial medications (hydroxychloroquine, quinine)
• anti-Parkinson's medications (e.g., apomorphine, entacapone, pramipexole, ropinirole, rotigotine)
• antipsychotics (e.g., aripiprazole, cariprazine, clozapine, haloperidol, quetiapine, olanzapine, risperidone)
• apalutamide
• apixaban
• aprepitant
• atomoxetine
• atropine
• "azole" antifungal medications (e.g., fluconazole, itraconazole, ketoconazole, voriconazole)
• barbiturates (e.g., butalbital, phenobarbital)
• benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
• benztropine
• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
• birth control pills
• bismuth subsalicylate
• bosentan
• brimonidine
• buprenorphine
• bupropion
• butorphanol
• caffeine
• calcium channel blockers (e.g., diltiazem, nifedipine, verapamil)
• cancer medications (e.g., mitotane, procarbazine)
• chloral hydrate
• cinacalcet
• clopidogrel
• cobicistat
• cocaine
• corticosteroids (e.g., dexamethasone, prednisone, methylprednisolone)
• dabigatran
• decongestant cold medications (e.g., phenylephrine, pseudoephedrine)
• decongestant eye drops and nose sprays (e.g., naphazoline, oxymetazoline, xylometazoline)
• deferasirox
• desmopressin
• diabetes medications (e.g., acarbose, canagliflozin,  glyburide, insulin, linagliptin, lixisenatide, metformin, rosiglitazone)
• diphenoxylate
• dipivefrin
• dipyridamole
• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
• domperidone
• edoxaban
• enzalutamide
• eplerenone
• esketamine
• fast-acting bronchodilators (e.g., salbutamol, terbutaline)
• flibanserin
• flunarizine
• fondaparinux
• general anesthetics (medications used to put people to sleep before surgery)
• glycopyrrolate
• grapefruit juice
• heparin
• herbal products that affect blood clotting (e.g., cat's claw, chamomile, fenugreek, evening primrose, feverfew, garlic, ginger, ginseng, turmeric)
• HIV non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, etravirine)
• HIV protease inhibitors (e.g., atazanavir, darunavir, ritonavir, tipranavir)
• hydralazine
• immunomodulators (e.g., leflunomide, pomalidomide, teriflunomide, thalidomide)
• ipratropium
• leflunomide
• lemborexant
• letermovir
• linezolid
• lithium
• long-acting bronchodilators (e.g., formoterol, salmeterol)
• low-molecular-weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• methadone
• methotrexate
• methylphenidate
• metoclopramide
• mifepristone
• mirtazapine
• monoamine oxidase inhibitors (e.g., tranylcypromine, phenelzine, rasagiline, selegiline, moclobemide)
• muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
• nabilone
• naltrexone
• nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
• omega-3 fatty acids
• other narcotic analgesics (e.g., fentanyl, morphine, oxycodone)
• overactive bladder medications (e.g., darifenacin, fesoterodine, mirabegron)
• ozanimod
• pentoxifylline
• pizotifen
• prasugrel
• protein kinase inhibitors (e.g., bortezomib, crizotinib, dabrafenib, dasatinib, imatinib, nilotinib, sunitinib)
• prucalopride
• quinidine
• quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, moxifloxacin)
• riociguat
• rifabutin
• rifampin
• rivaroxaban
• St. John's wort
• scopolamine
• seizure medications (e.g., carbamazepine, gabapentin, lamotrigine, levetiracetam, topiramate)
• serotonin-norepinephrine reuptake inhibitors (SNRIs; desvenlafaxine, duloxetine, venlafaxine)
• selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, sertraline)
• somatostatin-like drugs (e.g., lanreotide, octreotide, pasireotide)
• Sodium oxybate
• spironolactone
• sulfamethoxazole
• terbinafine
• tetrabenazine
• tetracycline antibiotics (e.g., doxycycline, minocycline, tetracycline)
• theophylline
• ticagrelor
• tiotropium
• trazodone
• tretinoin
• tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine)
• umeclidinium
• vaccines
• vitamin E
• warfarin
• zolpidem
• zopiclone

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.