Do not use this medication if you are allergic to acetaminophen, dextromethorphan, doxylamine, or pseudoephedrine, or to similar medications such as other decongestants, diet pills, stimulants, or ADHD medications.
Do not use 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 or cold medicine before the MAO inhibitor has cleared from your body.
Before taking acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine, tell your doctor if you are allergic to any drugs, or if you have:
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liver disease;
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alcoholism or cirrhosis of the liver;
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heart disease or high blood pressure;
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diabetes; or
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a thyroid disorder.
If you have any of these conditions, you may not be able to use this medication, or you may need a dosage adjustment or special tests during treatment.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Artifically-sweetened liquid forms of cough-and-cold medications may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.
Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cough-and-cold medicines should be taken only for a short time until your symptoms clear up.
Drink extra fluids to help loosen the congestion and lubricate your throat while you are taking this medication.
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. One packet of acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine powder may contain up to 1000 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.
Always ask your doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young
Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.
If you need to have any type of surgery, tell the surgeon ahead of time if you have used this medication within the past few days.
Store the medicine at room temperature, away from heat, light, and moisture.
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.
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 any of these serious side effects:
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fast, pounding, or uneven heartbeat;
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severe dizziness, anxiety, restless feeling, or nervousness;
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confusion, hallucinations, unusual thoughts or behavior;
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slow, shallow breathing;
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easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;
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increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or
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nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Keep using the medication and talk with your doctor if you have any of these less serious side effects:
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mild loss of appetite, upset stomach;
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warmth, tingling, or redness under your skin;
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sleep problems (insomnia);
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feeling excited or restless;
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skin rash or itching;
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Always ask your doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children.
Do not take 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 a cough or 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.
Do not use any other over-the-counter cough, cold, allergy, pain, or sleep 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 take to see if it contains acetaminophen, dexrtomethorphan, doxylamine, or pseudoephedrine.
Do not use any other over-the-counter cough, cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen, dextromethorphan, doxylamine and pseudoephedrine are contained in many cold, pain, and sleep medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you take to see if it contains acetaminophen, dexrtomethorphan, doxylamine, or pseudoephedrine.
Avoid drinking alcohol. It can increase 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) per day.
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.
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with cough or cold medicine can increase your risk of unpleasant side effects.
Before taking this medication, tell your doctor if you are using any of the following drugs:
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celecoxib (Celebrex);
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cinacalcet (Sensipar);
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darifenacin (Enablex);
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imatinib (Gleevec);
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isoniazid;
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quinidine (Quinaglute, Quinidex);
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ranolazine (Ranexa)
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ritonavir (Norvir);
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sibutramine (Meridia);
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terbinafine (Lamisil);
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zidovudine (Retrovir, AZT);
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medicines to treat high blood pressure;
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gout medications such as probenecid (Benbemid) or sulfinpyrazone;
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antidepressant medications such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), others;
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a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), esmolol (Brevibloc), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), or timolol (Blocadren); or
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seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).
If you are using any of these drugs, you may not be able to use acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine, or you may need dosage adjustments or special tests during treatment.
There may be other drugs not listed that can affect acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Seek emergency medical attention if you think you have used too much of this medicine.
Symptoms of an overdose may include dry mouth, feeling restless or nervous, dizziness, drowsiness, nausea, vomiting, diarrhea, stomach pain, loss of appetite, increased sweating, warmth or tingly feeling, seizure (convulsions), or coma.
