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Generic Name: acetaminophen/pseudoephedrine (a-seet-a-MIN-oh-fen/soo-do-e-FED-rin)
Brand Name: Examples include Alka-Seltzer Plus Cold/Sinus and Ornex
Ornex is used for:
Relieving symptoms such as pain and sinus congestion due to colds, upper respiratory infections, and allergies. It may also used for other conditions as determined by your doctor.
Ornex is an analgesic and decongestant combination. The analgesic works in the brain to help decrease pain. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages, which decreases stuffiness.
Do NOT use Ornex if:
- you are allergic to any ingredient in Ornex
- you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
- you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using Ornex:
Some medical conditions may interact with Ornex. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of adrenal gland problems (eg, adrenal gland tumor), heart problems, high blood pressure, diabetes, blood vessel problems, stroke, glaucoma, an enlarged prostate or other prostate problems, seizures, an overactive thyroid, severe kidney problems, or liver problems (eg, hepatitis), or if you consume more than 3 alcohol-containing drinks per day
Some MEDICINES MAY INTERACT with Ornex. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because side effects of Ornex may be increased
- Anticoagulants (eg, warfarin), digoxin, or droxidopa because risk of bleeding, irregular heartbeat, or heart attack may be increased
- Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Ornex
- Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Ornex
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ornex may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Ornex:
Use Ornex as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Ornex may be taken with or without food.
- If you miss a dose of Ornex, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Ornex.
Important safety information:
- Ornex may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Ornex. Using Ornex alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- Do not take diet or appetite control medicines while you are taking Ornex without checking with you doctor.
- Ornex contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
- Do NOT exceed the recommended dose or take Ornex for longer than prescribed without checking with your doctor.
- If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
- Ornex may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Ornex. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
- Ornex may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Ornex or other pain relievers/fever reducers. Alcohol use combined with Ornex may increase your risk for liver damage.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Ornex.
- Use Ornex with caution in the ELDERLY because they may be more sensitive to its effects.
- Caution is advised when using Ornex in CHILDREN because they may be more sensitive to its effects.
- PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Ornex, discuss with your doctor the benefits and risks of using Ornex during pregnancy. Ornex is excreted in breast milk. If you are or will be breast-feeding while you are using Ornex, check with your doctor or pharmacist to discuss the risks to your baby.
Possible side effects of Ornex:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mood or mental changes; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; stomach pain; tremor; vision changes; yellowing of skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.Proper storage of Ornex:
Store Ornex at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ornex out of the reach of children and away from pets.
- If you have any questions about Ornex, please talk with your doctor, pharmacist, or other health care provider.
- Ornex is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Ornex or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Ornex. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ornex. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Ornex.