acetaminophen/chlorpheniramine

Acetaminophen/chlorpheniramine is a combination medication used for the temporary relief of common cold and flu symptoms including headache, sneezing, runny nose, fever, and minor aches and pains. Acetaminophen reduces fever and pain while chlorpheniramine relieves cough, runny nose, sneezing and itchy nose and eyes. The two drugs are combined in specific dosages and the combo drug is available over the counter (OTC).

The two medications work in different ways and together they provide more effective relief than either of them as a single agent.

• Acetaminophen is an analgesic and an antipyretic drug. 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 makes breathing easier.

• Do not take acetaminophen/chlorpheniramine if you are hypersensitive to any component of the formulation.
• Do not take acetaminophen/chlorpheniramine concurrently with any other drug containing acetaminophen.
• Acetaminophen can severely damage the liver if an adult:
  • Takes more than 4,000 mg of acetaminophen in 24 hours
  • Concurrently takes other drugs containing acetaminophen
  • Drinks 3 or more alcoholic drinks while taking acetaminophen
• Liver damage can occur in children with half the dosage of an adult. Do not administer to children below 12 years unless prescribed and supervised by a pediatrician.
• Do not use acetaminophen for longer than:
  • Five days for pain in children
  • Ten days for pain in adults
  • Three days for fever
• Use with caution in elderly patients, who may be more sensitive to adverse effects.
• Check with your doctor before you take acetaminophen/chlorpheniramine if you have any of the following conditions:
  • Liver disease
  • Heart disease or high blood pressure (hypertension)
  • Chronic bronchitis, emphysema or other respiratory disorders
  • High intraocular pressure or glaucoma, an eye condition with high intraocular pressure that damages the optic nerve
  • Prostate enlargement with urinary obstruction
  • Thyroid disorder
  • G6PD enzyme deficiency, a genetic disorder
• Chlorpheniramine can cause drowsiness and taking concurrently with sedatives, tranquilizers or alcohol can increase drowsiness.
• Chlorpheniramine can cause significant excitability and drowsiness in children.
• Although rare, acetaminophen/chlorpheniramine can cause 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 the drug if such symptoms develop.

Common side effects of acetaminophen/chlorpheniramine include:

• Drowsiness
• Dizziness
• Fatigue
• Headache
• Tremors
• Insomnia
• Irritability
• Nervousness
• Anxiety
• Confusion
• Depression
• Euphoria
• Palpitations
• Rapid heart rate (tachycardia)
• Low blood pressure (hypotension)
• Dry nose, mouth and throat
• Thickening of bronchial secretions
• Wheezing
• Nausea
• Vomiting
• Diarrhea
• Constipation
• Loss of appetite (anorexia)
• Blood disorders including:
  • Low count of red blood cells (anemia)
  • 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.

Tablet

• 325 mg/2 mg

Adult and Pediatric:

Relief of Cold and Flu Symptoms

Children below 12 years:

• Safety and efficacy not established

Children 12 years above and adults:

• 2 tablets orally every 4 hours

Hepatic Impairment

• May tolerate low dose therapy but use caution; cases of hepatotoxicity at doses below 4 g/day reported

Overdose

• Overdose of acetaminophen/chlorpheniramine can lead to liver injury 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.
• Overdose of acetaminophen/chlorpheniramine may be treated with symptomatic and supportive measure, 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.

• Acetaminophen/chlorpheniramine has no listed severe interactions with other drugs.
• Serious interactions of acetaminophen/chlorpheniramine include:
  • abametapir
  • apalutamide
  • benzhydrocodone/acetaminophen
  • calcium/magnesium/potassium/sodium oxybates
  • eluxadoline
  • fexinidazole
  • idelalisib
  • isocarboxazid
  • lonafarnib
  • metoclopramide intranasal
  • pexidartinib
  • olopatadine intranasal
  • pretomanid
  • sodium oxybate
• Acetaminophen/phenyltoloxamine has moderate interactions with at least 238 other drugs.
• Acetaminophen/phenyltoloxamine has mild interactions with at least 57 other 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 should be used by pregnant women only if clearly needed. Check with your physician before use if you are pregnant.
• Acetaminophen/chlorpheniramine is likely present in breastmilk. Check with your physician before use if you are breastfeeding.
• If you are pregnant or breastfeeding, never take any OTC drug, including acetaminophen/chlorpheniramine, without first checking with your healthcare provider.

• Take acetaminophen/chlorpheniramine exactly as prescribed or as per label instructions if self-medicating with OTC medication.
• Do not take higher or more frequent doses, do not exceed the daily recommended dosage of acetaminophen 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:
  • Pain gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (adults)
  • Fever gets worse or lasts more than 3 days
  • Redness or swelling is present
  • New symptoms occur
  • Severe skin reactions develop
• Avoid drinking alcohol while taking acetaminophen/chlorpheniramine.
• Chlorpheniramine can cause drowsiness. Avoid engaging in hazardous activities such as driving or operating heavy machinery while taking acetaminophen/chlorpheniramine. 
• Store acetaminophen/chlorpheniramine safely out of reach of children.
• In case of overdose, seek immediate medical help or contact Poison Control.