Diphenhydramine HCl, Acetaminophen

FDA Drug Profile — Vicks ZzzQuil NIGHT PAIN NIGHTTIME SLEEP-AID PAIN RELIEVER

Drug Details

Generic Name
Diphenhydramine HCl, Acetaminophen
Brand Names
Vicks ZzzQuil NIGHT PAIN NIGHTTIME SLEEP-AID PAIN RELIEVER
Application Number
M010
Sponsor
The Procter & Gamble Manufacturing Company
NDC Codes
2
Dosage Forms
LIQUID
Routes
ORAL
Active Ingredients
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE

Indications and Usage

Use for the temporary relief of occasional minor aches and pains with accompanying sleeplessness.

Warnings

Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take • more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day 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 Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • for children under 12 years of age • with any other product containing diphenhydramine, even one used on skin