acetaminophen/phenyltoloxamine-oral, Dologesic, Flextra-650, Novagesic, Rhinoflex, Staflex (cont.)

HOW TO USE: Take this medication by mouth usually every 4 hours as needed; or as directed by your doctor. The dosage is based on your age, medical condition, and response to therapy. Do not exceed the recommended dosage or take this medication for longer than recommended (e.g., 10 days for adults, 5 days for children, or 3 days if used for fever); persistent symptoms of pain or fever may be the sign of a more serious medical condition. Consult your doctor for additional information. This medication contains acetaminophen. Do not take more acetaminophen than recommended (see Side Effects section).

SIDE EFFECTS: Drowsiness or nausea may occur. If either of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: skin redness, swelling, persistent fever, unusual weakness. If you do not have liver problems, the adult maximum dose of acetaminophen is 4 grams per day (4000 milligrams). If you take more than the maximum daily amount, it may cause serious (possibly fatal) liver disease. Tell your doctor immediately if you have any of the following symptoms of liver damage: severe nausea, yellowing eyes or skin, dark urine, stomach pain, extreme fatigue. If you notice other effects not listed above, contact your doctor or pharmacist.

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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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