Classes
DEA Class; OTC
Common Brand Names; Sudafed Triple Action, Tylenol Sinus Severe Congestion Daytime
- Cough/Cold, Other Combos;
- Analgesic/Decongestant/Expectorant 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
Pseudoephedrine: stimulates the alpha-adrenergic receptors causing bronchodilation & vasoconstriction
Guaifenesin: increases respiratory tract fluid secretions and helps to loosen phlegm and bronchial secretions
Indications
Indicated for Temporary Relief of Minor Aches & Pains, Headache, & Nasal Congestion
Contraindications
Hypersensitivity
Within 14 days of MAO inhibitor therapy
G-6-PD deficiency
Severe hepatic impairment
Adverse Effects
Arrhythmia
Palpitations
Convulsion
Dizziness
Drowsiness
Excitability
Headache
Tremor
Nausea
Vomiting
Dermatologic rash
Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)
Bilirubin & alkaline phosphatase may increase
Weakness
Warnings
Cardiovascular disease, diabetes mellitus, prostatic hypertrophy & increased intraocular pressure may occur with 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
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
Guaifenesin is not for administration in persistent cough associated with chronic bronchitis, smoking, asthma, or accompanied with excessive secretions
Pregnancy and Lactation
Pregnancy category: C
Lactation: excreted in breast milk, use caution
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
Maximum Dosage
2 tablets PO q4-6hr; not to exceed 8 capsules/day; not to exceed 1 g acetaminophen/4hr and 4 g aceteminophen/day
Pediatric
<12 years: Ask a pediatrician
≥12 years
2 tablets PO q4-6hr; not to exceed 8 capsules/day; not to exceed 1 g acetaminophen/4hr and 4 g aceteminophen/day