SIDE EFFECTS: See also Warning section. Nausea, vomiting, stomach upset, gas, shaking (tremor), constipation, dry mouth, lightheadedness, dizziness, drowsiness, or trouble sleeping may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener). Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: mental/mood changes, fast/irregular heartbeat, increased thirst/urination, hearing changes (e.g., ringing in the ears), easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), heartburn, discomfort when swallowing, dark urine, yellowing eyes/skin, signs of kidney problems (such as change in the amount of urine), signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss). Get medical help right away if you have any very serious side effects, including: fainting, seizure, black stools, severe stomach/abdominal pain, vomit that looks like coffee grounds, slurred speech, weakness on one side of the body. Codeine is changed into a strong opioid drug (morphine) in your body. In some people, this change happens faster and more completely than usual, which increases the risk of very serious side effects. Get medical help right away if you notice any of the following: slow/shallow breathing, severe drowsiness/difficulty waking up, confusion. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to aspirin, caffeine, codeine, or butalbital; or to other barbiturates (e.g., phenobarbital), salicylates (e.g., salsalate), nonsteroidal anti-inflammatory drugs (e.g., ibuprofen), opioid pain medications (e.g., morphine) or xanthine derivatives (e.g., theophylline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), breathing problems (e.g., chronic obstructive pulmonary disease-COPD, sleep apnea), bleeding/blood clotting disorders (e.g., hemophilia, von Willebrand's disease, thrombocytopenia), a certain enzyme disorder (porphyria), disease of the pancreas (e.g., pancreatitis), heart disease (e.g., irregular heartbeat, recent heart attack), certain enzyme deficiencies (pyruvate kinase or G6-PD deficiency), gout, liver disease, kidney disease, heartburn, growths in the nose (nasal polyps), a certain spinal problem (kyphoscoliosis), gallbladder disease, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), mental/mood disorders, stomach/intestinal problems (e.g., stomach/intestinal ulcers, infectious diarrhea, colitis), adrenal gland problem (e.g., Addison's disease), difficulty urinating (e.g., due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism), recent bowel/abdominal surgery, obesity. Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Avoid alcohol and stop smoking. Consult your doctor or pharmacist for more information. This medication contains aspirin. Children and teenagers less than 18 years old should not take aspirin if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine, without first consulting a doctor about Reye's syndrome, a rare but serious illness. Some children may be more sensitive to very serious side effects of the codeine in this product, such as extreme sleepiness, confusion, or slow/shallow/noisy breathing. (See also Warning section.) Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, slow/shallow breathing, stomach/intestinal bleeding and ulcers, and trouble falling asleep. Confusion, dizziness, drowsiness and trouble falling asleep can increase the risk of falling. Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication is not recommended for use during pregnancy. It may harm an unborn baby and interfere with normal labor/delivery. Consult your doctor for more details. This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also Warning section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: acetazolamide, antacids, anticholinergic medications (e.g., scopolamine), certain drugs used to treat gout (e.g., uricosuric drugs such as probenecid, sulfinpyrazone), certain antibiotics (e.g., penicillin, sulfonamides such as sulfamethoxazole), darunavir, drugs affecting liver enzymes that remove this medication from your body (such as cimetidine, disulfiram, valproic acid), lithium, MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), 6-mercaptopurine, methotrexate, methoxyflurane, mifepristone, naltrexone, other medications for pain (e.g., pentazocine, nalbuphine, morphine), sodium oxybate. This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others. This drug can speed up the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include corticosteroids such as prednisone, estrogen, felodipine, quinidine, certain beta blockers (such as metoprolol), theophylline, doxycycline. The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as morphine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products, other headache medications) because they may contain aspirin, caffeine or ingredients that cause drowsiness. Certain beverages (such as coffee, colas, tea) may also contain caffeine. Ask your pharmacist about using those products safely. Also, check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, aspirin, ketorolac) that may increase your risk for side effects if taken together with this medication. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details. Other medications can affect the removal of this product from your body, which may affect how this product works. Examples include azole antifungals (such as ketoconazole), bupropion, fluoxetine, macrolide antibiotics (such as erythromycin), HIV medications (such as ritonavir), paroxetine, rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. This medication may interfere with certain medical/laboratory tests (including fasting blood glucose, cholesterol levels, prothrombin time, urine 5-HIAA levels, amylase and lipase levels, certain urine glucose tests, dipyridamole-thallium imaging tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, slow/shallow breathing, very small pupils, severe dizziness, persistent nausea/vomiting, ringing in the ears, coma.