Acetaminophen Dextromethorphan Pseudoephedrine

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

Acetaminophen/dextromethorphan/pseudoephedrine is available under the following different brand names: Tylenol Cold Day Non-Drowsy, Tylenol Flu Non-Drowsy Maximum Strength, and Alka-Seltzer Plus Cold Non-Drowsy.

Dosages of Acetaminophen/Dextromethorphan/Pseudoephedrine:

Capsule

• 325mg/15mg/30mg

Gelcap

• 500mg/15mg/30mg

Dosage Considerations – Should be Given as Follows:

Symptomatic Relief of Cough and Congestion

• Adults
  • Based on acetaminophen component: 325 mg orally every 4-8 hours as needed; not to exceed 4 g/day
  • Based on dextromethorphan component: 10-20 mg orally every 4-8 hours or 30 mg orally every 8 hours; not to exceed 120 mg/24hours
  • Based on pseudoephedrine component: 60 mg orally every 4 hours; not to exceed 360 mg/24hours
• Pediatric
  • Based on acetaminophen component: 10-15 mg/kg/dose orally every 4-6 hours as needed; not to exceed 5 doses/24 hours

Based on the dextromethorphan component:

• Children under 6 years old: Ask a pediatrician
• Children 6-12 years old: 15 mg orally every 6-8 hours; not to exceed 60 mg/24hours
• Children over 12 years old: 10-20 mg orally every 4-8 hours or 30 mg orally every 8 hours; not to exceed 120 mg/24hours

Based on the pseudoephedrine component:

• Children under 2 years old: Ask a pediatrician
• Children 2-6 years old: 15 mg orally every 4 hours; not to exceed 90 mg/24hours
• Children 6-12 years old: 30 mg orally every 4 hours; not to exceed 180 mg/24hours
• Children over 12 years old: 60 mg orally every 4 hours; not to exceed 360 mg/24hours

Common side effects of Acetaminophen/Dextromethorphan/Pseudoephedrine include:

• Irregular heartbeats
• Palpitations
• Convulsions
• Dizziness
• Drowsiness
• Excitability
• Tremor
• Weakness
• Skin rash
• Gastrointestinal disturbances
• Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)
• Bilirubin and alkaline phosphatase

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
  • safinamide
  • selegiline
  • selegiline
  • selegiline transdermal
  • tranylcypromine
• Acetaminophen/dextromethorphan/pseudoephedrine has serious interactions with at least 50 different drugs.
• Acetaminophen/dextromethorphan/pseudoephedrine has moderate interactions with at least 210 different drugs.
• Mild interactions of acetaminophen/dextromethorphan/pseudoephedrine include:
  • amiodarone
  • asenapine
  • celecoxib
  • chloroquine
  • cimetidine
  • darifenacin
  • desmopressin
  • diphenhydramine
  • dronedarone
  • eucalyptus
  • haloperidol
  • imatinib
  • maraviroc
  • marijuana
  • nilotinib
  • parecoxib
  • perphenazine
  • propafenone
  • quinacrine
  • ranolazine
  • ritonavir
  • sage
  • sertraline

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains acetaminophen/dextromethorphan/pseudoephedrine. Do not take Tylenol Cold Day Non-Drowsy, Tylenol Flu Non-Drowsy Maximum Strength, or Alka-Seltzer Plus Cold Non-Drowsy if you are allergic to acetaminophen/dextromethorphan/pseudoephedrine or any ingredients contained in this drug.

Contraindications

• Contraindicated in documented hypersensitivity to the drugs or within 14 days of monoamine oxidase inhibitor (MAOI) therapy; known G-6-PD deficiency

Effects of Drug Abuse

• No information is available.

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Caution in cardiovascular disease, diabetes mellitus, prostatic hypertrophy and increased intraocular pressure when taking pseudoephedrine
• Acetaminophen hepatotoxicity is 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 the use of in pregnant or breastfeeding women. Pregnant or breastfeeding patients should seek the advice of a health professional before using over-the-counter (OTC) drugs.