Acetaminophen, Dextromethrophan, Doxylamine succinate, Phenylephrine HCl

FDA Drug Profile — Vicks NyQuil Severe Honey Cold and Flu, VICKS NyQuil SEVERE HONEY FLAVOR COLD and FLU, Nighttime Severe Honey Cold and Flu

Drug Details

Generic Name
Acetaminophen, Dextromethrophan, Doxylamine succinate, Phenylephrine HCl
Brand Names
Vicks NyQuil Severe Honey Cold and Flu, VICKS NyQuil SEVERE HONEY FLAVOR COLD and FLU, Nighttime Severe Honey Cold and Flu
Application Number
M012
Sponsor
Procter & Gamble Manufacturing Company
NDC Codes
3
Dosage Forms
LIQUID
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product child takes more than 4 doses (15 mL each) in 24 hrs, which is the maximum daily amount for this product taken with other drugs containing acetaminophen adult has 3 or more alcoholic drinks every day while using this product A llergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning : If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.