IBUPROFEN GEL SUSPENSION-ORAL, Elixsure IB (cont.)
HOW TO USE: Measure out each dose carefully and take this medication by mouth with a full glass (8 oz or 240 ml) of water unless your doctor directs you otherwise. Do not lie down for at least 30 minutes after taking this drug. If stomach upset occurs while taking this medication, take it with food, milk, or an antacid. The dosage is based on your medical condition and response to therapy. In children, the dosage is also based on weight. Read the product instructions to find the appropriate dose for your child's weight, or consult the pharmacist or doctor if you have questions. If repeat doses are needed, they are usually given 6 or 8 hours apart; or as directed by the doctor. Do not increase your dose or take it more frequently than recommended because this may increase the chance of stomach bleeding. In certain conditions (e.g., arthritis), it may take up to two weeks, taken regularly, before the full benefits of this drug take effect. If you are taking this drug on an "as needed" basis (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has significantly worsened, the medicine may not work as well. If you use this medication for migraine headache, and the pain is not relieved or worsens after the first dose, tell your doctor immediately. If you are treating yourself or giving this medication to a child for undiagnosed fever or pain, consult the doctor immediately if symptoms do not improve within 24 hours, worsen or last for more than 3 days, or if new symptoms appear.
SIDE EFFECTS: Upset stomach, nausea, vomiting, heartburn, headache, diarrhea, constipation, drowsiness, and dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these serious side effects occur: stomach pain, swelling of the hands or feet, sudden or unexplained weight gain, ringing in the ears (tinnitus). Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes, rapid or pounding heartbeat, easy bruising or bleeding. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: change in amount of urine, severe headache, very stiff neck, mental/mood changes, persistent sore throat or fever. This drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. If you notice any of the following unlikely but very serious side effects, stop taking ibuprofen and consult your doctor or pharmacist immediately: black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds. This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking ibuprofen and consult your doctor or pharmacist immediately: yellowing eyes and skin, dark urine, unusual/extreme tiredness. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
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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