Acetaminophen Dextromethorphan Phenylephrine

Acetaminophen/dextromethorphan/phenylephrine is an over-the-counter (OTC) product used for symptomatic relief of cough and congestion.

Acetaminophen/dextromethorphan/phenylephrine is available under the following different brand names: Alka-Seltzer Plus Day Cold, Theraflu Daytime Severe Cold & Cough, Tylenol Cold Multi-Symptom Daytime, Tylenol Cold Head Congestion Daytime, Vicks DayQuil Cold/Flu, Alka-Seltzer Plus Day Severe Cold, Cough & Flu, Alka-Seltzer Plus Day Sinus Congestion, Allergy & Cough, and Alka-Seltzer Plus Severe Sinus Congestion & Cough.

Dosage Forms and Strengths

Caplet

• 325mg/10mg/5mg

Rapid Release Gelcap

• 325mg/10mg/5mg

Capsule

• 325mg/10mg/5mg

Oral Solution

• (80mg/2.5mg/1.25mg)/1mL

Oral Suspension

• (160mg/5mg/2.5mg)/5mL

Liquid

• (325mg/10mg/5mg)/15mL

Powder for Solution

• (650mg/20mg/10mg)/Packet

Syrup

• (325mg/10mg/5mg)/15mL

Dosage Considerations – Should be Given as Follows:

Symptomatic Relief of Cough & Congestion

Adults and Children over 12 years:

• 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

Children 6-12 years old:

• Oral suspension: 10 mL orally every 4 hours; not to exceed 50 mL/day
• Oral solution: 4 mL orally every 4 hours as needed; not to exceed 24 mL/day

Children 4-6 years (36-47 pounds):

• Oral suspension: 5 mL orally every 4 hours; not to exceed 25 mL/day
• Oral solution: 2 mL orally every 4 hours as needed; not to exceed 12 mL/day

Children under 4 years old:

• Not recommended

Common side effects of Acetaminophen/Dextromethorphan/Phenylephrine include:

• High blood pressure (hypertension)
• Fast heart rate
• Severe peripheral and visceral vasoconstriction
• Dizziness
• Drowsiness
• Excitability
• Headache
• Restlessness
• Tremors
• Gastrointestinal disturbances
• Anemia blood disorders (neutropenia, pancytopenia, leukopenia)
• Bilirubin and alkaline phosphatase may increase

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

• Severe interactions of Acetaminophen Dextromethorphan Phenylephrine include:
  • iobenguane I 123
  • isocarboxazid
  • linezolid
  • phenelzine
  • phenelzine
  • procarbazine
  • rasagiline
  • selegiline transdermal
  • safinamide
  • selegiline
  • tranylcypromine
• Acetaminophen/dextromethorphan/phenylephrine has serious interactions with at least 44 different drugs.
• Acetaminophen/dextromethorphan/phenylephrine has moderate interactions with at least 232 different drugs.
• Acetaminophen/dextromethorphan/phenylephrine has mild interactions with at least 81 different drugs.
  • Barbiturates, carbamazepine, hydantoins, isoniazid, and rifampin may increase the hepatotoxic potential of acetaminophen and may decrease the analgesic effects of acetaminophen; cholestyramine may decrease acetaminophen absorption
  • Quinidine may inhibit the metabolism of dextromethorphan increasing its toxicity (adjust dose); concurrent use of dextromethorphan with monoamine oxidase inhibitors (MAOIs) may cause hyperpyrexia, abnormal muscle movement, hypotension, coma, and death (avoid use for 2 weeks after stopping the MAO inhibitor; coadministration of dextromethorphan with sibutramine may cause serotonin syndrome (concomitant use not recommended)
  • Guanethidine may increase pressor response of direct-acting vasopressors, like phenylephrine, possibly resulting in severe hypertension

Warnings

This medication contains acetaminophen/dextromethorphan/phenylephrine. Do not take Alka-Seltzer Plus Day Cold, Theraflu Daytime Severe Cold & Cough, Tylenol Cold Multi-Symptom Daytime, Tylenol Cold Head Congestion Daytime, Vicks DayQuil Cold/Flu, Alka-Seltzer Plus Day Severe Cold, Cough & Flu, Alka-Seltzer Plus Day Sinus Congestion, Allergy & Cough, or Alka-Seltzer Plus Severe Sinus Congestion & Cough if you are allergic to acetaminophen/dextromethorphan/phenylephrine or any ingredients contained in this drug.

Contraindications

• Documented hypersensitivity to the drugs
• Within 14 days of monoamine oxidase inhibitor (MAOI) therapy; known G-6-PD deficiency

Effects of Drug Abuse

• No information available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Acetaminophen/Dextromethorphan/Phenylephrine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Acetaminophen/Dextromethorphan/Phenylephrine?"

Cautions

• Caution in elderly patients, hyperthyroidism, myocardial disease, bradycardia, partial heart block or severe arteriosclerosis when administering phenylephrine; in hypovolemia, phenylephrine use is not a substitute for replacement of blood, fluids and electrolytes, and plasma (promptly restore with loss); dilute IV and administer via large vein; extravasation precautions required
• Acetaminophen hepatotoxicity possible in chronic alcoholics following various dose levels; severe or recurrent pain or high or continued fever may indicate a serious illness; contained in many over-the-counter (OTC) products and combined use with these products may result in toxicity due to cumulative doses exceeding recommended maximum dose
• Do not take dextromethorphan for persistent or chronic cough associated with smoking, asthma, or emphysema, or if it is accompanied by excessive phlegm unless directed by a healthcare provider; dextromethorphan may slow the breathing
• Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash

Pregnancy and Lactation

No information is available regarding use of acetaminophen/dextromethorphan/phenylephrine during pregnancy or while breastfeeding.

Pregnant or breastfeeding patients should seek advice of a health professional before using over-the-counter (OTC) drugs.