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|Codeine/Phenylephrine/Pyrilamine Syrup

Codeine/Phenylephrine/Pyrilamine Syrup

Codeine/Phenylephrine/Pyrilamine Syrup is used for:

Treating symptoms of the common cold, flu, or hay fever, and other upper respiratory allergies such as cough, congestion, runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes. Codeine/Phenylephrine/Pyrilamine Syrup may also be used for other conditions as determined by your doctor.

Codeine/Phenylephrine/Pyrilamine Syrup is a narcotic antitussive (cough suppressant), antihistamine, and decongestant combination. The antitussive works by suppressing the cough center in the brain. The antihistamine works by blocking the action of histamine, which reduces the symptoms of an allergic reaction such as itch, watery eyes and runny nose. The decongestant shrinks swollen nasal passages, which relieves nasal congestion.

Do NOT use Codeine/Phenylephrine/Pyrilamine Syrup if:

• you are allergic to any ingredient in Codeine/Phenylephrine/Pyrilamine Syrup or any other codeine-related medicine (eg, dihydrocodeine)
• you have diarrhea associated with poisoning, antibiotic use, or a bacterial infection (from eating or drinking contaminated food or water)
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
• 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/Phenylephrine/Pyrilamine Syrup:

Some medical conditions may interact with Codeine/Phenylephrine/Pyrilamine 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 a history of alcohol or drug abuse, dependence on narcotics, or suicidal thoughts or behaviors
• if you have increased pressure in the head, an unusual growth in the brain (eg, tumor), a recent head injury, Parkinson disease, Reye syndrome, the blood disease porphyria, or a blockage of your stomach, bowel, or bladder
• if you have a history of epilepsy or seizures, asthma or other breathing problems (eg, sleep apnea), stomach or intestinal problems, chronic constipation, liver problems, glaucoma, an enlarged prostate gland or other prostate problems, difficulty urinating, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, overactive thyroid, seizures, or stroke
• if you have recently had abdominal surgery

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

• Barbiturate anesthetics (eg, thiopental), beta-blockers (eg, propranolol), cimetidine, catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, ketorolac, MAO inhibitors (eg, phenelzine), naltrexone, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Codeine/Phenylephrine/Pyrilamine Syrup may be increased, including dangerous sleepiness and a decrease in the ability to breathe
• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased
• Rifampin or risperidone because the effectiveness of Codeine/Phenylephrine/Pyrilamine Syrup may be decreased
• Bromocriptine or hydantoins (eg, phenytoin) because the actions and side effects may be increased by Codeine/Phenylephrine/Pyrilamine Syrup
• Guanadrel, guanethidine, mecamylamine, methyldopa, mexiletine, or reserpine because the effectiveness may be decreased by Codeine/Phenylephrine/Pyrilamine Syrup
• Naltrexone because the effectiveness of Codeine/Phenylephrine/Pyrilamine Syrup will be decreased and withdrawal symptoms may occur in patients who have become physically dependent on opioids. You must not take naltrexone until you have stopped taking Codeine/Phenylephrine/Pyrilamine Syrup for 7 to 10 days and after a naloxone challenge test is negative.

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

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

• Codeine/Phenylephrine/Pyrilamine Syrup may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• 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/Phenylephrine/Pyrilamine Syrup and you are taking it regularly, 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/Phenylephrine/Pyrilamine Syrup.

Important safety information:

• Codeine/Phenylephrine/Pyrilamine 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/Phenylephrine/Pyrilamine Syrup. Using Codeine/Phenylephrine/Pyrilamine Syrup alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Do not drink alcohol while you are using Codeine/Phenylephrine/Pyrilamine Syrup. Avoid taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Codeine/Phenylephrine/Pyrilamine Syrup. Codeine/Phenylephrine/Pyrilamine Syrup will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• If your symptoms do not improve within 7 days or if you develop a high fever or persistent headache, check with your doctor.
• Use Codeine/Phenylephrine/Pyrilamine Syrup with caution in the ELDERLY because they may be more sensitive to its effects, especially possible breathing problems and drowsiness.
• Use Codeine/Phenylephrine/Pyrilamine Syrup with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is unknown if Codeine/Phenylephrine/Pyrilamine Syrup can cause harm to the fetus. If you become pregnant while taking Codeine/Phenylephrine/Pyrilamine Syrup, discuss with your doctor the benefits and risks of using Codeine/Phenylephrine/Pyrilamine Syrup during pregnancy. Codeine/Phenylephrine/Pyrilamine Syrup is excreted in breast milk. If you are or will be breast-feeding while you are using Codeine/Phenylephrine/Pyrilamine Syrup, check with your doctor or pharmacist to discuss the risks to your baby.

Use of Codeine/Phenylephrine/Pyrilamine Syrup can lead to TOLERANCE. When using for an extended period, Codeine/Phenylephrine/Pyrilamine Syrup may not work as well and may require different dosing. Talk with your doctor if Codeine/Phenylephrine/Pyrilamine Syrup stops working well.

Long-term use of Codeine/Phenylephrine/Pyrilamine Syrup can lead to physical DEPENDENCE. The early sign of addiction is medicine ineffectiveness. Dependence is not an issue in terminal illness, when pain relief is more important. If using Codeine/Phenylephrine/Pyrilamine Syrup for an extended period of time, do not suddenly stop taking Codeine/Phenylephrine/Pyrilamine Syrup without your doctor"s approval. WITHDRAWAL symptoms have occurred when Codeine/Phenylephrine/Pyrilamine Syrup is suddenly stopped and may include anxiety; diarrhea; fever; runny nose or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping. Contact your doctor if you notice any of these symptoms after stopping use of Codeine/Phenylephrine/Pyrilamine Syrup.

Possible side effects of Codeine/Phenylephrine/Pyrilamine 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:

Constipation; dizziness; drowsiness; dry mouth, throat, or nose; excitement; nausea; stomach upset; thickening or mucus in nose or throat.

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; flushing or redness of face.

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 agitation; coma; confusion; deep sleep or loss of consciousness; difficulty breathing; diminished mental alertness; hallucinations; hot or cold skin; large and unchanging pupils; sedation; seizures; shaking; sleeplessness; slowed breathing; slow heartbeat.

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

General information:

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