Classes
DEA Class; OTC
Common Brand Names; Theraflu Cold & Sore Throat, Theraflu Flu & Sore Throat
- Antitussives, Non-narcotic Combos
Description
Acetaminophen: Blocks pain impulse generation peripherally & may inhibit prostaglandin generation in CNS; reduces fever by inhibiting the hypothalamic heat-regulating center
Pheniramine: competes with histamine for histamine H1- receptor sites on effector cells; antihistamines antagonize the effects of histamine mediated through activation of H1- receptor sites, thereby reduces intensity of allergic reactions & tissue injury caused by histamine release
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 Allergy Symptoms & Common Cold
Contraindications
Hypersensitivity
Asthma
< 2 years old
Narrow-angle glaucoma
Symptomatic prostate hypertrophy
Bladder-neck obstruction
Stenosing peptic ulcer
Use within 14 days of MAO inhibitor therapy
G-6-PD deficiency
Severe hepatic impairment
Adverse Effects
Hypotension
Palpitations
Reflex hypertension
Severe peripheral and visceral vasoconstriction
Tachycardia
Confusion
Dizziness
Depression
Distress
Euphoria
Fatigue
Headache
Insomnia
Irritability
Restlessness
Sedation
Tremors
Dermatologic rash
Anorexia
Agranulocytosis
Warnings
Pheniramine: May cause significant confusional symptoms; not for administration to premature or full-term neonates
Phenylephrine: Caution in elderly patients, hyperthyroidism, myocardial disease, bradycardia, partial heart block or severe atherosclerosis
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
Pregnancy and Lactation
Pregnancy: C
Lactation: excreted in breast milk, use caution
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
Maximum Dosage
Dissolve contents of 1 packet in 8 oz of hot water; consume entire 8 oz within 10-15 minutes; not to exceed acetaminophen 1 g/dose or 4 g/day
Pediatric
<12 years: Ask a pediatrician
≥12 years: Dissolve contents of 1 packet in 8 oz of hot water; consume entire 8 oz within 10-15 minutes; not to exceed acetaminophen 1 g/dose or 4 g/day