acetaminophen/chlorpheniramine/phenylephrine

Acetaminophen/chlorpheniramine/phenylephrine is a combination medication used for the temporary relief of common cold and flu symptoms, including runny nose, itching of nose and throat, itching and watering eyes, fever, headache, body aches, cough, sore throat, and nasal and sinus congestion. The three drugs are combined in specific dosages and the combo drug is available over the counter (OTC).

Each medication in the combination works in a different way and together they provide more effective relief 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 causes allergy symptoms. Histamine is released by mast cells and basophils, types of immune cells, in response to allergen exposure. Chlorpheniramine binds to histamine H1 receptors in the smooth muscles of blood vessels and the respiratory tract preventing their activation by histamine that results in allergic reactions such as cough, itching and other symptoms.
• Phenylephrine belongs to a class of medications known as alpha1 agonists. Phenylephrine stimulates alpha1 adrenergic receptors, protein molecules located in smooth muscle tissues around blood vessels, making these muscles contract. This constricts the blood vessels in the nasal and sinus passages, reducing congestion.

• Do not use in patients with known hypersensitivity to acetaminophen, chlorpheniramine, phenylephrine, or any of the components in the formulation.
• Check with your doctor before you take acetaminophen/chlorpheniramine/phenylephrine if you have any of the following conditions:
  • Liver disease
  • Heart disease or high blood pressure (hypertension)
  • Diabetes mellitus
  • Thyroid disease
  • Asthma attacks, chronic bronchitis, or emphysema
  • Narrow-angle glaucoma, an eye condition with high intraocular pressure that damages the optic nerve
  • Prostate enlargement with urinary obstruction
  • Bladder neck obstruction
  • Stenosing peptic ulcer
  • G6PD enzyme deficiency, a genetic disorder
• Do not take acetaminophen/chlorpheniramine/phenylephrine concurrently or within 14 days after treatment with monoamine oxidase inhibitor (MAOI) type of antidepressant medications.
• Do not take it concurrently with any other drug containing acetaminophen.
• Acetaminophen can damage the liver, especially with prolonged use and high doses. Risk factors for severe liver damage include:
  • Taking more than 4,000 mg of acetaminophen in 24 hours
  • Concurrently taking other drugs containing acetaminophen
  • Drinking 3 or more alcoholic drinks while taking acetaminophen
• Chlorpheniramine can cause drowsiness and taking concurrently with sedatives, tranquilizers or alcohol can increase drowsiness.
• Do not administer to children below 2 years of age, chlorpheniramine can cause significant excitability and confusion in children. Check with the pediatrician before administering to children 12 years of age and below.
• There have been rare reports of life-threatening skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) with symptoms such as blisters, rash, and redness. Discontinue treatment if such symptoms develop.

Common side effects of acetaminophen/chlorpheniramine/phenylephrine include:

• Palpitations
• Rapid heart rate (tachycardia)
• Reflex tachycardia
• High blood pressure (hypertension)
• Low blood pressure (hypotension)
• Severe constriction of peripheral and abdominal (visceral) blood vessels
• Thickening of bronchial secretions
• Wheezing
• Fatigue
• Headache
• Dizziness
• Tremors
• Insomnia
• Sedation
• Irritability
• Confusion
• Excitability
• Restlessness
• Distress
• Depression
• Euphoria
• Loss of appetite (anorexia)
• Skin rash
• Blood disorders including:
  • Low count of red blood cells due to rapid destruction (hemolytic anemia)
  • Severely low count of granulocyte immune cells (agranulocytosis)
  • Low count of neutrophil immune cells (neutropenia)
  • Low count of leukocyte immune cells (leukopenia)
  • Low count of platelets (thrombocytopenia)
  • Low count of all types of blood cells (pancytopenia)
• Increase in bilirubin levels
• Increase in alkaline phosphatase enzyme levels

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.

Acetaminophen/chlorpheniramine/phenylephrine

Tablet

• 325 mg/2 mg/5 mg

Relief of Cold and Flu Symptoms

Adult and Pediatric:

Children below 12 years

• Ask a pediatrician

Adults and children above 12 years

• 2 tablets orally every 4 hours
• Not to exceed 12 tablets/day

Overdose

• Overdose of acetaminophen/chlorpheniramine/phenylephrine can result in liver damage from acetaminophen with severe adverse effects that include symptoms such as nausea, vomiting, loss of appetite, sweating, abdominal pain, extreme tiredness, yellowing eyes and skin, dark urine, agitation, confusion, hallucinations, and seizures.
• In children, overdose may result in excitement first, which may be followed by loss of coordination, drowsiness, loss of consciousness, and seizures.
• Overdose may be treated with symptomatic and supportive measures as required.

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.

• Severe interactions of acetaminophen/chlorpheniramine/phenylephrine include:
  • iobenguane I 123
  • isocarboxazid
  • linezolid
  • phenelzine
  • procarbazine
  • selegiline transdermal
  • tranylcypromine
• Acetaminophen/chlorpheniramine/phenylephrine has serious interactions with at least 34 different drugs.
• Acetaminophen/chlorpheniramine/phenylephrine has moderate interactions with at least 291 different drugs.
• Acetaminophen/chlorpheniramine/phenylephrine has mild interactions with at least 68 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 about 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 healthcare provider if you have any questions about the medication.

• Acetaminophen/chlorpheniramine/phenylephrine should be used by pregnant women only if clearly needed. Use the lowest effective dose for the shortest possible time.
• Acetaminophen/chlorpheniramine/phenylephrine is likely present in breast milk. Small occasional doses may be acceptable. Use with caution and check with your physician before use if you are breastfeeding.
• If you are pregnant or breastfeeding, do not take any OTC drug, including acetaminophen/chlorpheniramine/phenylephrine, without first checking with your healthcare provider.

• Take acetaminophen/chlorpheniramine/phenylephrine exactly as prescribed or as per label instructions if taking OTC medication.
• Do not take higher or more frequent doses, do not exceed the 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.
• Discontinue use and consult with your healthcare provider if:
  • Your cough lasts longer than seven days, reoccurs, or occurs with fever, rash, or persistent headaches. It could be a sign of a serious condition that should be diagnosed and treated.
  • You experience dizziness, nervousness, or sleeplessness.
  • You develop severe skin reactions.
• Avoid drinking alcohol while taking acetaminophen/chlorpheniramine/phenylephrine.
• Avoid engaging in hazardous activities such as driving or operating heavy machinery while taking acetaminophen/chlorpheniramine/phenylephrine, chlorpheniramine can cause drowsiness.
• Store safely out of reach of children.
• In case of overdose, seek immediate medical help or contact Poison Control.