Aspirin/Doxylamine/Dextromethorphan/Phenylephrine

DEA Class;  OTC

Common Brand Names; Alka-Seltzer Plus Night Cold & Cough Effervescent

Antitussives, Non-narcotic Combos

Aspirin irreversibly inhibits platelet aggregation by inhibiting platelet cyclooxygenase; acetyl group responsible for inactivation of cyclooxygenase via acetylation; hydrolyzed rapidly in plasma, in turn, inhibits conversion of arachidonic acid to PGI2 (potent vasodilator and inhibitor of platelet activation) and thromboxane A2 (potent vasoconstrictor and platelet aggregate)

Doxylamine competitively blocks histamine from binding to H1 receptors; significant antimuscarinic activity and penetrates CNS, which causes pronounced tendency to induce sedation

Dextromethorphan is a cough suppressant that acts centrally on the cough center in medulla

Phenylephrine is a vasoconstrictor & decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue; shrinks swollen mucous membranes, reduces nasal congestion and tissue hyperemia

Indicated for Relief of Cold Symptoms

Hypersensitivity

Liver damage

Hypoprothrombinemia

Vitamin K deficiency

Bleeding disorders

Asthma

Due to association of aspirin w/ Reye syndrome, do not use in children (<16 y) with viral infections

Use within 14 days of MAO inhibitor therapy

Narrow-angle glaucoma

Symptomatic prostate hypertrophy

Bladder-neck obstruction

Dysrhythmias

Hypotension

Tachycardia

Agitation

Cerebral edema

Coma

Confusion

Dizziness

Headache

Subdural or intracranial hemorrhage

Lethargy

Hives

Rashes

May potentiate peptic ulcer and cause stomach distress or heartburn

Dyspepsia

GI bleeding

Ulceration & perforation

Nausea

Vomiting

Prolongation of prothrombin time

Aspirin: May cause transient decrease in renal function and aggravate chronic kidney disease; avoid use in patients with severe anemia, history of blood coagulation defects, or taking anticoagulants

Dextromethorphan: Do not take 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; may decrease respiration rate

Doxylamine: May exacerbate angle closure glaucoma, hyperthyroidism, peptic ulcer, or urinary tract obstruction; xerostomia may occur

Phenylephrine: Caution in elderly patients, hyperthyroidism, myocardial disease, bradycardia, partial heart block or severe atherosclerosis

Pregnancy category: D; avoid during pregnancy, particularly in third trimester because of risk for premature closure of the ductus arteriosus

Lactation: Excreted in breast milk; do not breast feed

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

Adults

2 tablets fully dissolved in 4 oz of water qHS; may be taken q4-6hr; not to exceed 8 tablets/day

Pediatric 

<12 years

Not recommended

>12 years

2 tablets fully dissolved in 4 oz of water qHS; may be taken q4-6hr; not to exceed 8 tablets/day

Effervescent Tablet

500mg/6.25mg/10mg/7.8mg