Brand Names: Alka-Seltzer Plus Cough and Cold Liquigel, Child Tylenol Cold Multi-Symptom Plus Cough, Children's Tylenol Cold Plus Cough, Comtrex Cold and Flu Maximum Strength Liquid, Comtrex Cold and Flu Maximum Strength Tablet, Contac Cold and Flu Maximum Strength, Cough Formula M Multi-Symptom, Genacol Maximum Strength, Robitussin Flu, Robitussin Honey Flu Nighttime, Theraflu (pseudoephedrine) Cold & Cough, Theraflu Flu & Cough, Theraflu Flu, Cold and Cough Powder, Theraflu Night Cough and Cold and Flu, Theraflu Nightime Maximum Strength, Theraflu Severe Cold & Congestion, Triaminic Cold and Fever, Vicks 44 Cold, Flu and Cough, Vicks Formula 44M
Generic Name: acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine
- What is acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine?
- What are the possible side effects of this medicine?
- What is the most important information I should know about this medicine?
- What should I discuss with my healthcare provider before taking this medicine?
- How should I take this medicine?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while taking this medicine?
- What other drugs will affect this medicine?
- Where can I get more information?
What is acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine?
Chlorpheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine is a combination medicine used to treat headache, fever, body aches, cough, runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.
Acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine may also be used for purposes not listed in this medication guide.
What are the possible side effects of this medicine?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.
Stop using this medicine and call your doctor at once if you have:
- fast, slow, or uneven heart rate;
- chest pain, rapid pulse, feeling like you might pass out;
- severe dizziness or anxiety, mood changes, confusion, hallucinations;
- little or no urinating;
- nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or
- dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, seizure).
Common side effects may include:
- dizziness, drowsiness, mild headache;
- dry mouth, nose, or throat;
- constipation, diarrhea, upset stomach;
- blurred vision;
- feeling restless or irritable; 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.
What is the most important information I should know about this medicine?
Do not take more than your recommended dose. An acetaminophen overdose can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).
In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.
What should I discuss with my healthcare provider before taking this medicine?
Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.
You should not use this medication if you are allergic to acetaminophen, chlorpheniramine, dextromethorphan, or pseudoephedrine.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have other medical conditions, especially:
- liver disease, alcoholism, or if you drink more than 3 alcoholic beverages per day;
- a blockage in your digestive tract (stomach or intestines);
- bladder obstruction or other urination problems;
- high blood pressure, heart disease, coronary artery disease;
- overactive thyroid;
- asthma, COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
- pheochromocytoma (an adrenal gland tumor); or
- if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).
It is not known whether this medication will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.
Acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine may pass into breast milk and may harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.
How should I take this medicine?
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.
Do not take more of this medication than recommended. An acetaminophen overdose can damage your liver or cause death.
Do not give this medication to a child younger than 4 years old. 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.
The chewable tablet must be chewed before you swallow it.
Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away
Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.
If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.
Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.
What happens if I miss a dose?
Since this medicine is taken when 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.
What should I avoid while taking this medicine?
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.
This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.
What other drugs will affect this medicine?
Ask a doctor or pharmacist before using this medicine if you are also using any other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products. Some medicines can cause unwanted or dangerous effects when used together. Not all possible interactions are listed in this medication guide.
Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.
Where can I get more information?
Your pharmacist can provide more information about acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine.
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