Classes
DEA Class; OTC
Common Brand Names; Tylenol Cold Day Non-Drowsy, Tylenol Flu Non-Drowsy Maximum Strength, Alka-Seltzer Plus Cold Non-Drowsy
- Cough/Cold, Non-narcotic Combos;
- Analgesic/Decongestant Combos
Description
Acetaminophen blocks pain impulse generation peripherally and may inhibit the generation of prostaglandin in the CNS. Reduces fever by inhibiting the hypothalamic heat-regulating center.
Dextromethorphan is a cough suppressant that acts centrally on the cough center in the medulla.
Pseudoephedrine stimulates the alpha-adrenergic receptors causing bronchodilation and vasoconstriction.
Indications
For the Symptomatic Relief of Cough & Congestion
Contraindications
Contraindicated in documented hypersensitivity to the drugs or within 14 days of MAO inhibitor therapy; known G-6-PD deficiency
Adverse Effects
Arrhythmia
Palpitations
Convulsion
Dizziness
Drowsiness
Excitability
Tremor
Weakness
Dermatologic rash
GI disturbances
Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)
Bilirubin and alkaline phosphatase
Warnings
Caution in cardiovascular disease, diabetes mellitus, prostatic hypertrophy and increased intraocular pressure when taking pseudoephedrine
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 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
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
Maximum Dosage
Based on acetaminophen component: 325 mg PO q4-8hr PRN; not to exceed 4 g/day
Based on dextromethorphan component: 10-20 mg PO q4-8hr or 30 mg PO q8hr; not to exceed 120 mg/24hours
Based on pseudoephedrine component: 60 mg PO q4hr; not to exceed 360 mg/24hours
Based on acetaminophen component: 10-15 mg/kg/dose PO q4-6hr PRN; not to exceed 5 doses/24hours
Based on dextromethorphan component
<6 years old: Ask a pediatrician
6-12 years old: 15 mg PO q6-8hr; not to exceed 60 mg/24hours
>12 years old: 10-20 mg PO q4-8hr or 30 mg PO q8hr; not to exceed 120 mg/24hours
Based on pseudoephedrine component
<2 years old: Ask a pediatrician
2-6 years old: 15 mg PO q4hr; not to exceed 90 mg/24hours
6-12 years old: 30 mg PO q4hr; not to exceed 180 mg/24hours
>12 years old: 60 mg PO q4hr; not to exceed 360 mg/24hours