SIDE EFFECTS: Nausea, vomiting, dry mouth, dizziness, drowsiness, blurred vision, or constipation 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. This medication causes urine and sometimes stools to turn blue-green. This effect is harmless and will disappear when the medication is stopped. 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: hot/dry/flushed skin, decreased sweating, eye pain, difficult urination, signs of kidney problems (such as change in the amount of urine, painful urination). Get medical help right away if you have any very serious side effects, including: easy bruising/bleeding, black/tarry stools, stomach/abdominal pain, vomit that looks like coffee grounds, signs of liver problems (such as unusual tiredness, dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin). This drug may rarely cause an attack of extremely high blood pressure (hypertensive crisis), which may be fatal. Many drug interactions can increase this risk (see Drug Interactions section). Get medical help right away if any of these serious side effects occur: severe headache, fast/slow/irregular/pounding heartbeat, chest pain, neck stiffness/soreness, severe nausea/vomiting, sweaty/clammy skin (sometimes with fever), widened pupils, vision changes (such as double/blurred vision), sudden sensitivity to light (photophobia). This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness. 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 any of its ingredients; or to aspirin or NSAIDs (such as ibuprofen); or to belladonna alkaloids (such as atropine, scopolamine); 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: kidney problems, liver problems, urinary blockage problems, difficulty urinating (such as due to an enlarged prostate), stomach/intestinal disorders (such as obstruction, ulcers), glaucoma (narrow angle type), heart problems (such as coronary heart disease, congestive heart failure, fast/irregular heartbeat), high blood pressure, myasthenia gravis, bleeding/clotting problems, certain enzyme deficiencies (pyruvate kinase or G6PD deficiency), aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), growths in the nose (nasal polyps), stroke, severe/frequent headaches, a certain kind of adrenal gland tumor (pheochromocytoma), dehydration. This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana. Also, limit tobacco and alcohol use to lower the risk of stomach bleeding. This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication is not recommended for use in children younger than 6 years. Children are more sensitive to the side effects of this drug, especially unusual excitement, hot/dry/flushed skin, decreased sweating. This product contains salicylate, which is related to aspirin. Children and teenagers should not take aspirin or aspirin-related medications if they have chickenpox, flu, or any undiagnosed illness, or if they have recently received a live virus vaccine (such as flu vaccine given in the nose, varicella vaccine), without first consulting the doctor. A rare but serious illness known as Reye's syndrome may occur. Older adults may be more sensitive to the side effects of this drug, especially confusion, agitation, drowsiness, unusual excitement, constipation, and difficulty urinating. Confusion and drowsiness can increase the risk of falling. This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use 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. This medication may interact with many products. Some products include: apraclonidine, atomoxetine, bupropion, buspirone, carbamazepine, cyclobenzaprine, dextromethorphan, maprotiline, methotrexate, mifepristone, potassium capsules/tablets, pramlintide, tetrabenazine, some narcotic drugs (such as fentanyl, meperidine, methadone, tapentadol), certain Parkinson's disease drugs (entacapone, levodopa, tolcapone), certain high blood pressure drugs (guanethidine, methyldopa), sulfonamide drugs (including sulfa antibiotics such as sulfamethoxazole), sympathomimetics (such as amphetamine, ephedrine), tricyclic antidepressants (such as amitriptyline/nortriptyline), products that decrease the amount of acid in the urine (such as antacids, sodium bicarbonate, potassium/sodium citrate, acetazolamide). 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. Taking other MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking other MAO inhibitors (isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication. The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/ "ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. Before using this product, report the use of other drugs that may increase the risk of extremely high blood pressure (hypertensive crisis) when combined with this product, including herbal products (such as ephedra/ma huang), nasal decongestants (such as phenylephrine, pseudoephedrine), stimulants (such as amphetamines, ephedrine, epinephrine), diet aids, among others. This product should not be used with any of these medications. Talk to your doctor or pharmacist for more details. If you are also taking azole antifungal drugs (such as itraconazole, ketoconazole), take this product at least 2 hours after the antifungal drug. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen, ketorolac or naproxen). These drugs are similar to salicylate and may increase your risk of side effects if taken together. 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. Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. This medication may interfere with certain laboratory 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, call 911. Otherwise, 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: fever, fast/pounding heartbeat, severe dizziness, seizures, slowed/shallow breathing, unusual excitement.