Classes
DEA Class; OTC
Common Brand Names; Alka-Seltzer Plus Severe Allergy Sinus Congestion & Headache, Vicks NyQuil Sinus, QlearQuil Nighttime Sinus & Congestion Relief
- Antihistamine/Decongestant/Analgesic Combos
Description
Acetaminophen: Blocks pain impulse generation peripherally & may inhibit the generation of prostaglandin in the CNS; reduces fever by inhibiting hypothalamic heat-regulating center
Doxylamine: Competitively blocks histamine from binding to H1 receptors; significant antimuscarinic activity & penetrates CNS, which causes pronounced tendency to induce sedation
Phenylephrine: Vasoconstrictor & decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue; shrinks swollen mucous membranes, reduces nasal congestion & tissue hyperemia
Indications
Indicated for Sinus Pain, Congestion, Rhinorrhea, Sneezing, Headache
Contraindications
Documented hypersensitivity
Asthma
Narrow-angle glaucoma
Symptomatic prostate hypertrophy
Bladder-neck obstruction
Stenosing peptic ulcer
Known G-6-PD deficiency
Adverse Effects
Hypertension
Reflex tachycardia
Severe peripheral & visceral vasoconstriction
Dizziness
Drowsiness
Excitability
Headache
Restlessness
Tremor
Dermatologic rash
Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)
Bilirubin & alkaline phosphatase may increase
Dry mouth, throat, and nose
Thickening of mucus in nose or throat
Warnings
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
Doxylamine may exacerbate angle closure glaucoma, hyperthyroidism, peptic ulcer, or urinary tract obstruction; xerostomia may occur
Phenylephrine is a vasoconstrictor and may increase blood pressure
Pregnancy and Lactation
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
Maximum Dosage
2 capsules PO q4hr; not to exceed 6 doses/day
Pediatric
<12 years: Ask a pediatrician
≥12 years: 2 capsules PO q4hr; not to exceed 6 doses/day