HOW TO USE: See also Warning section.Take this medication by mouth, usually every 4-6 hours with or without food with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. This medication may be taken with food or milk if stomach upset occurs.The dosage is based on your medical condition and response to treatment. This product contains acetaminophen. Do not take more acetaminophen than recommended. (See also Side Effects and Precautions sections.)This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as anxiety, restlessness, sweating, shaking, chills, nausea, vomiting, and diarrhea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.When used for an extended time, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.Inform your doctor if your condition persists or worsens.
SIDE EFFECTS: See also Warning section.Drowsiness, dizziness, headache, blurred vision, upset stomach, nausea, constipation, or dry mouth/nose/throat may occur. If any of these effects persist or worsen, notify 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 can dry up and thicken mucus in your lungs, making it more difficult to breathe and clear your lungs. To help prevent this effect, drink plenty of fluids unless otherwise directed by your doctor.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 (e.g., hallucinations), ringing in the ears, shaking (tremors), trouble urinating, weakness, easy bruising/bleeding, fast/slow/irregular heartbeat.Get medical help right away if you have any very serious side effects, including: seizure.This product may cause serious mental/mood changes and very serious (rarely fatal) breathing problems. This product may contain codeine or dihydrocodeine. Codeine and dihydrocodeine are changed into strong narcotic drugs (morphine or dihydromorphine) in your body. In some people this 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, unusual 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.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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