USES: 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.
HOW TO USE: See also Warning section.Take this medication by mouth, with a full glass of water (8 ounces or 240 milliliters) 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/tablets a day (4 capsules/tablets for children 6 to 11 years old).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.
SIDE EFFECTS: See also Warning section.Dizziness, drowsiness, constipation, nausea, vomiting, stomach upset, 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, 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.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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