Classes
DEA Class; OTC
Common Brand Names; Excedrin Sinus Headache, Sinutab Sinus Maximum Strength Tablets, QlearQuil Daytime Sinus & Congestion Relief, Sine-Off Non-Drowsy Maximum Strength Tablets, Sudafed PE Sinus Headache, Robitussin Peak Cold Nasal Relief, Tylenol Infants Drops Plus Cold, Tylenol Sinus Congestion & Pain Daytime, Vicks DayQuil Sinus
- Cough/Cold, Other Combos;
- Analgesic/Decongestant 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.
Phenylephrine is a vasoconstrictor and a decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue. It shrinks swollen mucous membranes, reduces nasal congestion and tissue hyperemia.
Indications
Indicated for Relief of Mild to Moderate Pain & Congestion, Flu Symptoms, Common Cold
Contraindications
Both drugs contraindicated in documented hypersensitivity to either drug or components
Within 14 days of taking a monoamine oxidase inhibitor
Longer than 10 days if experiencing pain, 3 days if experiencing fever, 2 days if experiencing sore throat
Adverse Effects
Hypertension
Reflex tachycardia
Severe peripheral and visceral vasoconstriction
Dizziness
Excitability
Headache
Restlessness
Tremor
Dermatologic rash
Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)
Bilirubin and alkaline phosphatase
Warnings
Risk of hepatotoxicity; higher in alcoholics, or with use of more than one acetaminophen-containing product
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
Closely monitor in hyperthyroidism, DM, heart disease, bowel obstruction/narrowing, increased intraocular pressure, BPH
Use caution in the elderly, in patients with bowel obstruction/narrowing, asthma, diabetes mellitus, cardiovascular disease, hyperthyroidism, hypertension, hyperplasia, increased intraocular pressure, and prostatic hyperplasia; if symptoms do not improve within 7 days or are accompanied by fever, contact healthcare professional
Discontinue and inform healthcare provider if dizziness, nervousness, or sleeplessness occur
Pregnancy and Lactation
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
Maximum Dosage
650 mg/10 mg PO q4hr PRN; not to exceed 6 doses/24hr
1000 mg/10 mg PO q6hr PRN; not to exceet 4 doses/24hr
Pediatric
<12 years: Ask a pediatrician
≥12 years
650mg/10mg PO q4hr PRN; not to exceed 6 doses/24hr
1000mg/10mg PO q6hr PRN; not to exceet 4 doses/24hr