Classes
DEA Class; OTC
Common Brand Names; Alka-Seltzer Plus Night Cold Formula, Tylenol Cold Multi-Symptom Nighttime Liquid, Alka-Seltzer Plus Night Severe Cold, Cough & Flu, Alka-Seltzer Plus Night Sinus Congestion, Allergy & Cough
- Cough/Cold, Non-narcotic Combos;
- Analgesic/Antihistamine/Antitussive/Decongestant 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
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
Dextromethorphan: cough suppressant that acts centrally on the cough center in the medulla
Doxylamine competitively blocks histamine from binding to H1 receptors; significant antimuscarinic activity and penetrates CNS, which causes pronounced tendency to induce sedation
Phenylephrine is a vasoconstrictor and a decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue; shrinks swollen mucous membranes, reduces nasal congestion and tissue hyperemia
Indications
Indicated in Congestion, Rhinorrhea, Cough, Sore Throat, Headache, Fever, Minor Aches & Pains
Contraindications
Hypersensitivity
Asthma
Narrow-angle glaucoma
Symptomatic prostate hypertrophy
Bladder-neck obstruction
Stenosing peptic ulcer
G-6-PD deficiency
Severe hepatic impairment
Adverse Effects
Hypertension
Reflex tachycardia
Severe peripheral and visceral vasoconstriction
Dizziness
Drowsiness
Excitability
Headache
Restlessness
Tremor
Dermatologic rash
GI disturbances
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
Acetaminophen contained in many OTC products & 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 respiration rate
Doxylamine may exacerbate angle closure glaucoma, hyperthyroidism, peptic ulcer, or urinary tract obstruction; xerostomia may occur
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 caps PO q4hr PRN; not to exceed 12 caps/day
Pediatric
<12 Years
Ask a pediatrician
≥12 Years
2 caps PO q4hr PRN; not to exceed 12 caps/day