acetaminophen/chlorpheniramine/dextromethorphan

Acetaminophen/chlorpheniramine/dextromethorphan is a combination medication used for the temporary relief of common cold and flu symptoms, including fever, headache, muscle aches, sore throat, cough, runny nose and sneezing. The three drugs are combined in specific dosages and the combination drug is available over the counter (OTC).

Acetaminophen reduces fever and pain, chlorpheniramine relieves runny nose, sneezing, and itchy nose and eyes, and dextromethorphan suppresses the coughing urge. Each medication in the combination works uniquely to provide more effective relief together than any of them as a single agent.

• Acetaminophen is an analgesic and antipyretic drug used to relieve pain and fever. Acetaminophen relieves pain by blocking pain impulse generation and inhibiting the synthesis of prostaglandin in the central nervous system (CNS). Prostaglandin is a natural substance in the body that initiates inflammation. Acetaminophen reduces fever by acting on the hypothalamus region of the brain, which regulates temperature.
• Chlorpheniramine works by blocking the activity of histamine, a natural compound in the body that produces reactions such as cough, sneeze, itching and other reactions to get rid of substances that irritate the system. Chlorpheniramine binds to H1 receptors in the smooth muscles of the respiratory tract, and prevents activation of muscle contraction by histamine, relaxing the smooth muscles and making breathing easier. Chlorpheniramine crosses the blood-brain barrier and can also induce sedation.
• Dextromethorphan suppresses cough by reducing the sensitivity of cough receptors in the brain region that stimulate the cough reflex and preventing the transmission of cough impulses.

• Do not use acetaminophen/chlorpheniramine/dextromethorphan in patients with known hypersensitivity to any component of the formulation.
• Do not take concurrently with any other drug containing acetaminophen.
• Do not take concurrently or within 14 days after treatment with monoamine oxidase inhibitor (MAOI) type of antidepressant medications.
• If you are taking any of the following medications, check with your physician before taking acetaminophen/chlorpheniramine/dextromethorphan:
  • Warfarin, a blood thinning drug
  • Sedatives or tranquilizers
• Do not administer in children below 2 years of age, and do not administer to children below 12 years of age without direction and supervision by a pediatrician.
• Do not take acetaminophen/chlorpheniramine/dextromethorphan without checking with your physician if you have any of the following conditions:
  • Liver disease
  • Impaired kidney or liver function
  • Cardiovascular disease, including high blood pressure
  • Increased intraocular pressure
  • Narrow-angle glaucoma, a condition that damages the optic nerve
  • Respiratory conditions such as asthma, emphysema or chronic bronchitis
  • Prostate enlargement and associated urinary obstruction
  • Bladder neck obstruction
  • Stenosing peptic ulcer
• Acetaminophen can damage the liver, especially with prolonged high dosages. Risk of liver damage is higher with concurrent use of other acetaminophen products, and in alcoholics. Advise patients to ideally avoid or at least limit alcohol intake.
• Use acetaminophen/chlorpheniramine/dextromethorphan with caution in patients with known G6PD enzyme deficiency, a genetic disorder.
• Use with caution in elderly patients.
• Use acetaminophen products with caution in patients with low blood volume (hypovolemia).
• There have been rare reports of life-threatening skin reactions with the use of acetaminophen, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) with symptoms such as blisters, rash and redness. Discontinue the drug if such symptoms develop.

Common side effects of acetaminophen/chlorpheniramine/dextromethorphan include:

• Dizziness
• Fatigue
• Headache
• Tremors
• Sedation
• Insomnia
• Confusion
• irritability
• Distress
• Depression
• Euphoria
• Low blood pressure (hypotension)
• Rapid heartbeat (tachycardia)
• Palpitations
• Skin rash
• Gastrointestinal disturbances
• Loss of appetite (anorexia)
• Wheezing
• Thickening of bronchial secretions
• Blood disorders including:
  • Low red blood cell count (anemia)
  • Anemia due to premature red cell destruction (hemolytic anemia)
  • Low count of neutrophil immune cells (neutropenia)
  • Low count of leukocyte immune cells (leukopenia)
  • Severely low count of granulocyte immune cells (agranulocytosis)
  • Low platelet count (thrombocytopenia)
  • Low counts of all types of blood cells (pancytopenia)
• Increase in bilirubin
• Increase in alkaline phosphatase enzyme

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Tablet

• 500 mg/2 mg/15 mg

Adult and pediatric:

Relief of Cold and Flu Symptoms

Children below 12 years:

• Safety and efficacy not established

Adults and children 12 years and above:

• 2 tablets orally once every 6 hours; not to exceed 8 tablets/day

Overdose

• Overdose of acetaminophen/chlorpheniramine/dextromethorphan can cause severe symptoms that can be fatal if not treated promptly.
• Acetaminophen damages the liver and kidneys, causing symptoms such as nausea, vomiting, loss of appetite, abdominal pain, extreme tiredness, yellowing of eyes and skin, reduced urine output, low blood pressure (hypotension) and rapid heart rate.
• Chlorpheniramine causes flushing, fever, hallucinations, weakness, tremor, seizure and loss of consciousness. In children, overdose may result in excitement first followed by loss of coordination, drowsiness, loss of consciousness and seizures.
• Dextromethorphan causes nausea, vomiting, stupor, coma, respiratory depression, seizures, high heart rate, blurred vision, uncontrolled eye movements, impairment of speech, balance and coordination, changes in muscle reflexes, involuntary muscle contractions, hyperexcitability and toxic psychosis.
• Overdose treatment may include administration of N-acetylcysteine, antidote to acetaminophen, and other symptomatic and supportive measures, including gastric lavage and activated charcoal to eliminate the undigested drug.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Acetaminophen/chlorpheniramine/dextromethorphan has no known severe interactions with other drugs.
• Serious interactions of acetaminophen/chlorpheniramine/dextromethorphan include:
  • abametapir
  • apalutamide
  • benzhydrocodone/acetaminophen
  • buprenorphine subdermal implant
  • buprenorphine transdermal
  • buprenorphine, long-acting injection
  • calcium/magnesium/potassium/sodium oxybates
  • eluxadoline
  • fexinidazole
  • idelalisib
  • isocarboxazid
  • lonafarnib
  • metoclopramide intranasal
  • pexidartinib
  • olopatadine intranasal
  • pretomanid
  • sodium oxybate
• Acetaminophen/chlorpheniramine/dextromethorphan has moderate interactions with at least 239 different drugs.
• Acetaminophen/chlorpheniramine/dextromethorphan has mild interactions with at least 57 different drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• Acetaminophen/chlorpheniramine/dextromethorphan should be used by pregnant women only if clearly needed.
• Acetaminophen/chlorpheniramine/dextromethorphan is present in breastmilk. Check with your physician before using if you are a nursing mother.
• If you are pregnant or breastfeeding, do not take any OTC drug, including acetaminophen/chlorpheniramine/dextromethorphan, without first checking with your healthcare provider.

• Take acetaminophen/chlorpheniramine/dextromethorphan exactly as prescribed or as per label instructions.
• Do not take higher or more frequent doses, do not exceed daily recommended dosage and do not take for prolonged periods.
• Avoid overdose by checking product labels carefully. Acetaminophen is found in many dosage forms and many combination products.
• Discontinue immediately if you develop hypersensitivity reactions or severe skin reactions and contact your physician.
• Discontinue use and consult with your healthcare provider if:
  • Your sore throat is severe and persists for longer than two days, or is accompanied by fever, rash, headache, nausea or vomiting
  • Your pain or cough lasts longer than seven days
  • If your cough reoccurs, or occurs with fever, rash, or persistent headaches
  • Your fever gets worse or lasts longer than three days
  • You have skin redness or swelling
  • You develop new symptoms
• If you have chronic cough associated with smoking, asthma, or emphysema, or if your cough occurs with heavy phlegm or mucus, check with your physician before taking acetaminophen/chlorpheniramine/dextromethorphan.
• Avoid taking sedatives or tranquilizers, and avoid or limit intake of alcohol while on treatment with acetaminophen/chlorpheniramine/dextromethorphan, it can worsen the drowsiness induced by the drug.
• Avoid engaging in hazardous tasks such as driving or operating heavy machinery while taking acetaminophen/chlorpheniramine/dextromethorphan.
• Store acetaminophen/chlorpheniramine/dextromethorphan safely out of reach of children.
• In case of overdose, seek immediate medical help or contact Poison Control.