Night Time Severe Cold and Flu

Night Time Severe Cold and Flu is an FDA drug label for the active ingredient ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL manufactured by Walgreen Company administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231229.

Generic: ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL

Manufacturer: Walgreen Company

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 0363-0331

Application: M012

Effective: 20231229

Active Ingredients: Active ingredients (in each 30 mL dose cup or 2 tablespoons) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Doxylamine Succinate 12.5 mg Phenylephrine HCl 10 mg

Indications & Usage

Uses Temporarily relieves cold/flu symptoms: ■ nasal congestion ■ sinus congestion & pressure ■ sore throat ■ headache ■ minor aches and pain ■ runny nose and sneezing ■ temporarily reduces fever ■ cough due to minor throat and bronchial irritation ■ promotes nasal and/or sinus drainage

Dosage & Administration

Directions ■ take only as recommended. See Warnings ■ use dose cup or tablespoon (TBSP) ■ do not exceed 4 doses per 24 hours Age Dose Adults & children 12 years & over 30 mL (2 TBSP) every 4 hours Children 4 to under 12 years Ask a doctor Children under 4 years Do not use ■ do not exceed 4 doses per 24 hours

Contraindications

Not available.

Warnings

Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 4 doses in 24 hours, which is the maximum daily amount ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily while using this product. Allergy 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.

Adverse Reactions