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|Codeine/Pseudoephedrine Syrup

Codeine/Pseudoephedrine Syrup

Codeine/Pseudoephedrine Syrup is used for:

Relieving congestion and cough due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Codeine/Pseudoephedrine Syrup is a decongestant and cough suppressant. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Codeine/Pseudoephedrine Syrup if:

• you are allergic to any ingredient in Codeine/Pseudoephedrine Syrup or any other codeine or morphine related medicine (eg, oxycodone)
• you have severe high blood pressure, rapid heartbeat, or other severe heart problems (eg, heart blood vessel disease)
• you are taking sodium oxybate (GHB) or if 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 Codeine/Pseudoephedrine Syrup:

Some medical conditions may interact with Codeine/Pseudoephedrine Syrup. 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 had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to morphine, codeine, or any other opiate (eg, hydrocodone, dihydrocodeine, oxycodone)
• if you have a history of glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, stroke, adrenal gland problems, or an overactive thyroid
• if you have a history of stomach problems, bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery
• if you have breathing or lung problems (eg, asthma, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus
• if you have or recently had any head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures
• if you have a history of alcohol or substance abuse or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Codeine/Pseudoephedrine Syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), cimetidine, COMT inhibitors (eg, tolcapone), furazolidone, HIV protease inhibitors (eg, ritonavir), indomethacin, MAO inhibitors (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects from Codeine/Pseudoephedrine Syrup may be increased
• Digoxin, droxidopa, or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, seizures, irregular heartbeat, or heart attack may be increased
• Naltrexone and quinidine because the effectiveness of Codeine/Pseudoephedrine Syrup may be decreased.
• Bromocriptine because the risk of side effects may be increased by Codeine/Pseudoephedrine Syrup
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Codeine/Pseudoephedrine Syrup

This may not be a complete list of all interactions that may occur. Ask your health care provider if Codeine/Pseudoephedrine Syrup 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 Codeine/Pseudoephedrine Syrup:

Use Codeine/Pseudoephedrine Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Codeine/Pseudoephedrine Syrup may be taken with or without food.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Codeine/Pseudoephedrine Syrup, 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 Codeine/Pseudoephedrine Syrup.

Important safety information:

• Codeine/Pseudoephedrine Syrup may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Codeine/Pseudoephedrine Syrup. Using Codeine/Pseudoephedrine Syrup alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Do not take appetite suppressants while you are taking Codeine/Pseudoephedrine Syrup without checking with your doctor.
• Codeine/Pseudoephedrine Syrup contains pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
• Do NOT exceed the recommended dose or take Codeine/Pseudoephedrine Syrup 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.
• Codeine/Pseudoephedrine Syrup may interfere with certain lab test results. Make sure that all of your doctors and lab personnel know that you are taking Codeine/Pseudoephedrine Syrup.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Codeine/Pseudoephedrine Syrup.
• Use Codeine/Pseudoephedrine Syrup with caution in the ELDERLY because they may be more sensitive to its effects.
• Caution is advised when using Codeine/Pseudoephedrine Syrup in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Codeine/Pseudoephedrine Syrup, discuss with your doctor the benefits and risks of using Codeine/Pseudoephedrine Syrup during pregnancy. It is unknown if Codeine/Pseudoephedrine Syrup is excreted in breast milk. Do not breast-feed while taking Codeine/Pseudoephedrine Syrup.

Possible side effects of Codeine/Pseudoephedrine Syrup:

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:

Dizziness; drowsiness; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; tremor.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), 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.

Store Codeine/Pseudoephedrine Syrup 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 Codeine/Pseudoephedrine Syrup out of the reach of children and away from pets.

General information:

• If you have any questions about Codeine/Pseudoephedrine Syrup, please talk with your doctor, pharmacist, or other health care provider.
• Codeine/Pseudoephedrine Syrup 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.

This information is a summary only. It does not contain all information about Codeine/Pseudoephedrine Syrup. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.