acetaminophen/dextromethorphan/phenylephrine

Acetaminophen/dextromethorphan/phenylephrine is a combination medication used for the temporary relief of common cold and flu symptoms, including 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.
• 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.
• 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 the 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, dextromethorphan, phenylephrine or any of the components in 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.
• Use with caution in elderly patients.
• Acetaminophen can damage the liver, especially with prolonged use with high doses.
• Use acetaminophen/dextromethorphan/phenylephrine with caution in patients with G6PD enzyme deficiency, a genetic disorder.
• Use acetaminophen/dextromethorphan/phenylephrine with caution in patients with any of the following conditions:
  • Cardiovascular diseases including hypertension and ischemic heart disease
  • Diabetes mellitus
  • Active liver disease or liver function impairment
  • Increased intraocular pressure or glaucoma, a condition that damages the optic nerve
  • Prostate enlargement and urinary obstruction
  • Thyroid dysfunction
• Use with caution in patients with alcoholic liver disease. Drinking 3 or more alcoholic drinks a day can increase the risk of liver damage. Advise patients to avoid drinking or limit to less than 3 drinks a day.
• Use with caution in patients with kidney impairment. Adjust dosage if necessary.
• Use with caution in chronic malnutrition.
• Some formulations may contain sulfites, which may cause allergic reactions in some people.
• Some formulations may contain propylene glycol, which can be toxic in large quantities.
• Some formulations may contain phenylalanine, which should be avoided in patients with phenylketonuria, a disorder with inability to metabolize phenylalanine.
• 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/dextromethorphan/phenylephrine include:

• Dizziness
• Drowsiness
• Headache
• Tremor
• Excitability
• Restlessness
• Gastrointestinal disturbances
• Reflex increase in heart rate (reflex tachycardia)
• High blood pressure (hypertension)
• Blood disorders including:
  • Low red blood cell count (anemia)
  • Low count of neutrophil immune cells (neutropenia)
  • Low count of leukocyte immune cells (leukopenia)
  • Low count of all types of blood cells (pancytopenia)
• Increase in bilirubin levels
• Elevated 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/dextromethorphan/phenylephrine

Caplet

• 325 mg/10 mg/5 mg

Rapid Release Gelcap

• 325 mg/10 mg/5 mg

Capsule

• 325 mg/10 mg/5 mg

Liquid

• 325 mg/10 mg/5 mg/15 mL

Powder for Solution

• 650 mg/20 mg/10 mg/packet
• 500 mg/20 mg/10 mg/packet

Syrup

• 325 mg/10 mg/5 mg/15 mL

Adult:

Symptomatic Relief of Cough and Congestion

• 1 packet orally every 4 hours; not to exceed 6 doses/day
• 2 caplets/capsules orally every 4 hours; not to exceed 12 caplets/capsules/day
• 30 mL liquid/syrup orally every 4 hours; not to exceed 6 doses (12 tablespoons)/day
• 2 gelcaps every 4 hours; not to exceed 12 gelcaps/day

Pediatric:

Symptomatic Relief of Cough and Congestion

Children below 4 years old

• Not recommended for use

Children 6-12 years old

• Liquid: acetaminophen 325 mg/dextromethorphan 10 mg/phenylephrine 5 mg per 15 mL: 15 mL every 4 hours
• Not to exceed: 60 mL (acetaminophen 1,300 mg/dextromethorphan 40 mg/phenylephrine 20 mg) per 24 hours

Children above 12 years old

• 1 packet orally every 4 hours; not to exceed 6 doses/day
• 2 caplets/capsules orally every 4 hours; not to exceed 12 caplets/capsules/day
• 30 mL liquid/syrup orally every 4 hours; not to exceed 6 doses (12 tablespoons)/day
• 2 gelcaps every 4 hours; not to exceed 12 gelcaps/day

Overdose

• Overdose of acetaminophen/dextromethorphan/phenylephrine can damage the liver and cause severe adverse effects with symptoms that include nausea, vomiting, loss of appetite, sweating, abdominal pain, extreme tiredness, yellowing eyes and skin, dark urine, agitation, confusion, hallucinations and seizures.
• Overdose treatment may include administration of N-acetylcysteine, antidote to acetaminophen, and other symptomatic and supportive measures as needed.

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/dextromethorphan/phenylephrine include:
  • iobenguane I 123
  • isocarboxazid
  • linezolid
  • phenelzine
  • procarbazine
  • selegiline transdermal
  • tranylcypromine
• Acetaminophen/dextromethorphan/phenylephrine has serious interactions with at least 25 different drugs.
• Acetaminophen/dextromethorphan/phenylephrine has moderate interactions with at least 192 different drugs.
• Acetaminophen/dextromethorphan/phenylephrine has mild interactions with at least 58 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/dextromethorphan/phenylephrine should be used by pregnant women only if clearly needed. The lowest effective dose for the shortest possible time is recommended.
• Acetaminophen/dextromethorphan/phenylephrine is likely safe to take while breastfeeding, use with caution.
• If you are pregnant or breastfeeding, do not take any OTC drug, including acetaminophen/dextromethorphan/phenylephrine, without first checking with your healthcare provider.

• Take acetaminophen/dextromethorphan/phenylephrine exactly as prescribed or as per label instructions if taking OTC medication.
• 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.
• 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.
• Check with the physician before taking acetaminophen/dextromethorphan/phenylephrine if you have chronic cough associated with smoking, asthma, or emphysema, or if it occurs with heavy phlegm or mucus.
• Avoid or limit intake of alcohol while on treatment.
• Store safely out of reach of children.
• In case of overdose, seek immediate medical help or contact Poison Control.