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|Codeine/Phenylephrine/Promethazine Syrup

Codeine/Phenylephrine/Promethazine Syrup

Codeine/Phenylephrine/Promethazine Syrup is used for:

Treating cough, congestion, and other upper respiratory symptoms caused by allergies or the common cold. It may also be used for other conditions as determined by your doctor.

Codeine/Phenylephrine/Promethazine Syrup is a phenothiazine antihistamine, decongestant, and narcotic cough suppressant combination. The antihistamine works by blocking the action of histamine to reduce the symptoms of an allergic reaction, such as runny nose and sinus drainage. The decongestant works by constricting blood vessels, which shrinks swollen and congested nasal tissue. The cough suppressant works in the brain to decrease the cough reflex.

Do NOT use Codeine/Phenylephrine/Promethazine Syrup if:

• you are allergic to any ingredient in Codeine/Phenylephrine/Promethazine Syrup, any other codeine-related medicine (eg, oxycodone), or phenothiazines (eg, chlorpromazine)
• you have severe drowsiness, severe high blood pressure, severe blood vessel disease, rapid heartbeat, or severe heart problems
• you have certain lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease, sleep apnea), or if you have a fever and a productive cough
• you have diarrhea associated caused by food poisoning or antibiotic use
• you are taking sodium oxybate (GHB)
• you are taking furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or have taken one of them within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Codeine/Phenylephrine/Promethazine Syrup:

Some medical conditions may interact with Codeine/Phenylephrine/Promethazine 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 heart problems, high or low blood pressure, blood problems (eg, porphyria), bone marrow problems, blood vessel problems (eg, narrowing, poor circulation), or stroke
• if you have a history of seizures, liver or kidney problems, diabetes, increased pressure in the eye (eg, glaucoma), Parkinson disease, adrenal problems (eg, Addison disease, pheochromocytoma), or thyroid problems
• if you have a history of enlarged prostate; bladder problems (eg, blockage); stomach or bowel problems (eg, inflammation, blockage); gallbladder problems; chronic constipation; ulcer; or recent stomach, bowel, or bladder surgery
• if you are dehydrated, have poor health, have trouble sleeping, or have recently had a fever, any head injury, brain injury or tumor, increased pressure in the brain, infection of the brain or nervous system, or Reye syndrome
• if you have a chronic cough or lung or breathing problems (eg, chronic bronchitis, slow or shallow breathing), or if your cough occurs with large amounts of mucus
• if you have a history of alcohol or other substance abuse, mental or mood problems, or suicidal thoughts or attempts

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

• Barbiturates (eg, phenobarbital), cimetidine, meperidine, narcotics (eg, morphine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because the risk of severe drowsiness or serious breathing problems may be increased
• Digoxin, droxidopa, epinephrine, haloperidol, or sympathomimetics (eg, albuterol) because the risk of irregular heartbeat or heart attack may be increased
• Furazolidone or MAOIs (eg, phenelzine) because a severe reaction, which may include headache, fever, and severe high blood pressure, may occur
• Local anesthetics (eg, lidocaine) because the risk of seizures may be increased
• Amphetamines, anticholinergics (eg, scopolamine, atropine), beta-blockers (eg, proranolol), catechol-o-methyltransferase (COMT) inhibitors (eg, entacapone), certain weight loss medicines (eg, phentermine), ergot alkaloids (eg, ergotamine), HIV protease inhibitors (eg, indinavir), or indomethacin because they may increase the risk of Codeine/Phenylephrine/Promethazine Syrup"s side effects
• Naltrexone, quinidine, rifampin, or risperidone because they may decrease Codeine/Phenylephrine/Promethazine Syrup"s effectiveness
• Bromocriptine because side effects may be increased by Codeine/Phenylephrine/Promethazine Syrup
• Guanadrel, guanethidine, levodopa, mecamylamine, methyldopa, pergolide, or reserpine because their effectiveness may be decreased by Codeine/Phenylephrine/Promethazine Syrup

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

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

• Take Codeine/Phenylephrine/Promethazine Syrup by mouth 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/Phenylephrine/Promethazine 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/Promethazine Syrup.

Important safety information:

• Codeine/Phenylephrine/Promethazine Syrup may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Codeine/Phenylephrine/Promethazine Syrup with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Codeine/Phenylephrine/Promethazine Syrup without checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Codeine/Phenylephrine/Promethazine Syrup may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• If cough persists for more than 5 days or is accompanied by a high fever, contact your doctor. A persistent cough could be a sign of a serious condition.
• Do not use Codeine/Phenylephrine/Promethazine Syrup for a cough with a lot of mucous. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.
• Codeine/Phenylephrine/Promethazine Syrup may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Codeine/Phenylephrine/Promethazine Syrup. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Codeine/Phenylephrine/Promethazine Syrup. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
• Diabetes patients - Codeine/Phenylephrine/Promethazine Syrup may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Tell your doctor or dentist that you take Codeine/Phenylephrine/Promethazine Syrup before you receive any medical or dental care, emergency care, or surgery.
• Codeine/Phenylephrine/Promethazine Syrup may interfere with certain lab tests, including certain enzyme levels and certain pregnancy tests. Be sure your doctor and lab personnel know you are taking Codeine/Phenylephrine/Promethazine Syrup.
• Use Codeine/Phenylephrine/Promethazine Syrup with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion and drowsiness.
• Codeine/Phenylephrine/Promethazine Syrup should not be used in CHILDREN younger than 16 years old; serious and sometimes fatal breathing problems have occurred when Codeine/Phenylephrine/Promethazine Syrup has been used in these children.
• PREGNANCY and BREAST-FEEDING: Codeine/Phenylephrine/Promethazine Syrup may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Codeine/Phenylephrine/Promethazine Syrup while you are pregnant. Codeine/Phenylephrine/Promethazine Syrup is found in breast milk. If you are or will be breast-feeding while you use Codeine/Phenylephrine/Promethazine Syrup, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, Codeine/Phenylephrine/Promethazine Syrup may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Codeine/Phenylephrine/Promethazine Syrup stops working well. Do not take more than prescribed.

Some people who use Codeine/Phenylephrine/Promethazine Syrup for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Codeine/Phenylephrine/Promethazine Syrup suddenly, you may have WITHDRAWAL symptoms. These 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; and trouble sleeping.

Possible side effects of Codeine/Phenylephrine/Promethazine 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:

Anxiety; blurred vision; constipation; dizziness; drowsiness; dry mouth, throat, or nose; headache; nausea; nervousness; restlessness; tiredness or weakness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; agitation; chest pain; confusion; change in the amount of urine produced; fast, slow, or irregular heartbeat; fainting; hallucinations; loss of coordination; mood or mental changes; muscle pain or stiffness; overexcitement; seizures; severe drowsiness; severe or persistent blurred vision, dizziness, headache, or lightheadedness; slow or irregular breathing; symptoms of infection (eg, fever, chills); tremors; uncontrolled muscle movements (eg, movements of the arms, legs, tongue, eyes); unusual bruising or bleeding; unusual sweating; vision problems; yellowing of the skin or eyes.

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 cold or clammy skin; coma; dilated or pinpoint pupils; exaggerated reflexes; limp or rigid muscles; loss of consciousness; seizures; severe dizziness or drowsiness; severe or persistent headache or vomiting; slow or difficult breathing; slow or irregular heartbeat.

Store Codeine/Phenylephrine/Promethazine Syrup at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Codeine/Phenylephrine/Promethazine Syrup out of the reach of children and away from pets.

General information:

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