Acetaminophen and Diphenhydramine hydrochloride

Acetaminophen and Diphenhydramine hydrochloride is an FDA drug label for the active ingredient ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE manufactured by Aurohealth LLC 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 20231129.

Generic: ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE

Manufacturer: Aurohealth LLC

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 58602-760

Application: M013

Effective: 20231129

Active Ingredients: Drug Facts Active ingredients (in each gelcap) Acetaminophen USP 500 mg Diphenhydramine hydrochloride USP 25 mg

Indications & Usage

Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage & Administration

Directions do not take more than directed adults and children 12 years and over take 2 gelcaps at bedtime do not take more than 2 gelcaps of this product in 24 hours. children under 12 years: do not use

Contraindications

Not available.

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take with other drugs containing acetaminophen more than 4,000 mg of acetaminophen in 24 hours 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.

Adverse Reactions