Acetaminophen is a pain reliever and fever reducer.
Codeine is a narcotic cough suppressant.
Guaifenesin is an expectorant. It helps loosen mucus congestion in your chest and throat, making it easier to cough out through your mouth.
Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of acetaminophen, codeine, guaifenesin, and phenylephrine is used to treat stuffy nose, cough, pain and fever, and to reduce chest congestion caused by upper respiratory infections or the common cold.
Acetaminophen, codeine, guaifenesin, and phenylephrine may also be used for other purposes not listed in this medication guide.
Do not take this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a cough and cold medicine before the MAO inhibitor has cleared from your body.
Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. If you drink more than three alcoholic beverages per day, do not take this medication without your doctor's advice, and never take more than 2 grams (2000 mg) of acetaminophen per day.
Do not use any other cough, cold, or allergy medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen (sometimes abbreviated as "APAP"), guaifenesin, or phenylephrine.Do not give this medicine to a child without a doctor's advice. Death can occur from the misuse of cough or cold medicine in very young children. Always ask your doctor before treating a cough or cold in a child.
Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. You should not use acetaminophen, codeine, guaifenesin, and phenylephrine if you have ever had an allergic reaction to it, or if you have:
severe or uncontrolled high blood pressure;
severe coronary artery disease;
if you are breast-feeding a baby; or
if you are having an asthma attack.
If you have certain conditions, you may need a dose adjustment or special tests to safely take acetaminophen, codeine, guaifenesin, and phenylephrine. Before taking this medication, tell your doctor if you have:
FDA pregnancy category C. This medication may be harmful to an unborn baby. Codeine can cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while you are taking this medication. This medication can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication if you are breast-feeding a baby. Codeine may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Older adults may be more likely to have side effects from this medication.
heart disease or high blood pressure;
ischemic heart disease (reduced circulation of blood to the heart);
asthma, COPD, or other breathing disorder;
a history of head injury or brain tumor;
epilepsy or other seizure disorder;
a thyroid disorder;
- kidney or liver disease;
a stomach or intestinal disorder;
Addison's disease or other adrenal gland disorders; or
if you have recently had surgery on your stomach, intestines, kidney, or bladder.
Take this medication exactly as it was prescribed for you. Do not take it in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Cough and cold medicine is usually taken for only a short time until your symptoms clear up.Take this medicine with food or milk if it upsets your stomach. An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. Know the amount of acetaminophen in the specific product you are taking. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Call your doctor if your cough does not improve after 5 days of treatment, or if you also have a fever.
This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using acetaminophen, codeine, guaifenesin, and phenylephrine.Store the medicine at room temperature away from moisture, heat, and light.
Keep track of how many pills have been used from each bottle of this medication. Codeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.
Since cough or cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention if you think you have used too much of this medicine.
Overdose symptoms may include extreme dizziness or drowsiness, feeling restless or nervous, hallucinations, nausea, vomiting, stomach pain, loss of appetite, increased sweating, seizure (convulsions), blue-colored lips or fingernails, slow heart rate, weak pulse, pinpoint pupils, fainting, or slow breathing (breathing may stop).
This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
Do not use any other cough, cold, pain, or allergy medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP"), guaifenesin, and phenylephrine are contained in many combination medicines. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, guaifenesin, or phenylephrine.Avoid drinking alcohol. It can increase some side effects of codeine, and increases your risk of liver damage while taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) of acetaminophen per day. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). This medication can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:
fast, pounding, or uneven heartbeat;
slow heart rate, weak pulse, fainting, weak or shallow breathing;
severe dizziness, anxiety, restless feeling, or nervousness;
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
mild nausea, vomiting, or stomach upset;
mild loss of appetite;
skin rash or itching;
warmth, tingling, or redness under your skin;
feeling excited or restless; or
sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by codeine or guaifenesin.
Also tell your doctor about all other medicines you use, especially:
medicines to treat high blood pressure;
a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or
an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.
This list is not complete and there may be other drugs that can interact with codeine and phenylephrine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
- Your pharmacist can provide more information about acetaminophen, codeine, guaifenesin, and phenylephrine.
Copyright 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 4/12/2009 4:46:26 PM.;
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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