Classes
DEA Class; OTC
Common Brand Names; Theraflu Warming Relief Cold & Chest Congestion, Tylenol Sinus Congestion & Pain Severe, Sudafed PE Triple Action, Mucinex Fast-Max Cold & Sinus
- Cough/Cold, Other Combos;
- Analgesic/Decongestant/Expectorant Combos
Description
Acetaminophen blocks pain impulse generation peripherally & may inhibit the generation of prostaglandin in the CNS; reduces fever by inhibiting the hypothalamic heat-regulating center
Phenylephrine is a vasoconstrictor and decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue; shrinks swollen mucous membranes, reduces nasal congestion and tissue hyperemia
Guaifenesin increases respiratory tract fluid secretions and helps to loosen phlegm and bronchial secretions.
Indications
Indicated for Temporary Relief of Sinus Congestion, Headache, Minor Aches & Pains
Contraindications
Hypersensitivity
G-6-PD deficiency
Severe hepatotoxicity
Adverse Effects
Hypertension
Severe peripheral and visceral vasoconstriction
Tachycardia
Dizziness
Drowsiness
Excitability
Headache
Restlessness
Tremor
Dermatologic rash
Nausea
Vomiting
Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)
Bilirubin and alkaline phosphatase may increase
Warnings
Phenylephrine: Caution in elderly patients, hyperthyroidism, myocardial disease, bradycardia, partial heart block or severe arteriosclerosis
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: 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 tabs PO q4hr; not to exceed 12 tabs/24hr; not to exceed 1g/hr or 4g/day of acetaminophen
30 mL [(325mg/5mg/200mg)/15mL] PO q4hr
20 mL [(162.5mg/5mg/2.5mg/100mg)/5mL] PO q4hr
Pediatric
<12 years: Ask a pediatrician
≥12 years
2 tabs PO q4hr; not to exceed 12 tabs/24hr; not to exceed 1g/hr or 4g/day of acetaminophen
30 mL [(325mg/5mg/200mg)/15mL] PO q4hr
20 mL [(162.5mg/5mg/2.5mg/100mg)/5mL] PO q4hr