One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. If you have liver problems, consult your doctor or pharmacist for a safe dosage of this medication. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol. Check with your doctor or pharmacist for more information. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, stomach/abdominal pain, extreme tiredness, or yellowing eyes/skin.

Acetaminophen is an ingredient found in many nonprescription products and in some combination prescription medications (such as pain/fever drugs or cough-and-cold products). Carefully check the labels on all your medicines because they may also contain acetaminophen. Ask your pharmacist about using those products safely. Get medical help right away if you have taken more than 4000 milligrams of acetaminophen a day, even if you feel well.

This combination medication is used to treat mild to moderate pain (e.g., headache, arthritis, muscle pain, cold/flu aches and pain). Salicylamide and acetaminophen help to decrease the pain. Phenyltoloxamine is an antihistamine that helps to decrease symptoms of a cold such as a runny nose. Caffeine is thought to increase the effects of acetaminophen and salicylamide.

See also Warning section.

Take this medication by mouth, usually every 4 hours with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. Do not lie down for at least 10 minutes after taking this drug. If stomach upset occurs, take this medication with food, milk, or an antacid.

Dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Discuss the risks and benefits with your doctor or pharmacist.

For adults and children older than 11 years, do not take more than 8 capsules a day.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the symptoms have worsened, the medication may not work as well.

Tell your doctor if your condition persists or worsens. Do not take this product for more than 10 days unless directed by your doctor.

See also Warning section.

Dizziness, drowsiness, constipation, nausea, vomiting, stomach upset, trouble sleeping, heartburn, blurred vision, or dry mouth/nose/throat may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

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 immediately if any of these unlikely but serious side effects occur: stomach pain, swelling of ankles/feet/hands, sudden/unexplained weight gain, difficulty urinating, fast/slow/irregular heartbeat, mental/mood changes (e.g., nervousness, anxiety, irritability), shaking (tremor), unusual weakness, vision changes, hearing changes (e.g., ringing in the ears, decreased hearing), seizures.

Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), black stools, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before taking this medication, tell your doctor or pharmacist if you are allergic to salicylamide, acetaminophen, phenyltoloxamine, or caffeine; or to salicylates (e.g., magnesium salicylate); or to other antihistamines (e.g., diphenhydramine); 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: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), kidney disease, liver disease, growths in the nose (nasal polyps), breathing problems (e.g., asthma, chronic obstructive pulmonary disease-COPD), stomach/intestine/esophagus problems (e.g., bleeding, ulcers, recurring heartburn, blockage), bleeding/clotting problems, glaucoma, difficulty urinating (e.g., due to enlarged prostate gland), poorly controlled diabetes, stroke, seizure, overactive thyroid gland (hyperthyroidism), heart disease (e.g., congestive heart failure, history of heart attack), swelling of the ankles/feet/hands, a severe loss of body water (dehydration), blood disorders (e.g., anemia), high blood pressure, mental/mood disorders, certain genetic conditions (G6PD deficiency, pyruvate kinase deficiency).

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

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.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially stomach bleeding and dizziness.

This medication contains salicylamide, which is similar to aspirin. Children and teenagers should not take this medication (or 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.

Caution is advised when using this drug in children because they are more sensitive to the effects of antihistamines. This drug can often cause excitement in young children instead of drowsiness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug may pass 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.

See also Warning section.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: cidofovir, ketorolac.

If you are currently using either of these medications listed above, tell your doctor or pharmacist before starting this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: adenosine, antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), anti-seizure medications (e.g., phenytoin, carbamazepine, phenobarbital, valproic acid), carbonic anhydrase inhibitors (e.g., acetazolamide), certain drugs for gout (uricosuric drugs such as probenecid, sulfinpyrazone), cimetidine, corticosteroids (e.g., prednisone), cyclosporine, disulfiram, drugs for Parkinson's disease (e.g., anticholinergics such as benztropine), isoniazid, lithium, MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), methotrexate, pemetrexed, phenothiazines (e.g., chlorpromazine), tenofovir, theophylline, vemurafenib.

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.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., risperidone, trazodone). Check all prescription and nonprescription medicine labels (e.g., cough-and-cold products, pain relievers, fever reducers) carefully since many contain ingredients that cause drowsiness.

Also check your prescription and nonprescription medicine labels carefully because they may contain caffeine, other ingredients that could increase your heart rate or blood pressure (e.g., cough-and-cold products, diet aids), and/or drugs that are similar to salicylamide and, if taken together, may increase your risk for side effects (NSAIDs such as aspirin, ibuprofen, naproxen). Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day). Also remember that certain beverages (e.g., coffee, colas, tea) and chocolate contain caffeine. Consult your doctor or pharmacist for more details. (See also adult maximum daily dose information for acetaminophen in Side Effects section.)

This medication may interfere with certain medical/laboratory tests (including urine 5-HIAA, skin tests, dipyridamole-thallium imaging tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact a poison control center or emergency room immediately. 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: persistent nausea/vomiting, severe stomach/abdominal pain, mental/mood changes, severe drowsiness/dizziness, ringing in the ears, fast/irregular heartbeat, shaking (tremor).

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

Laboratory and/or medical tests (e.g., liver/kidney function test) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If you are taking this drug on a regular schedule (not "as needed") and you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.