Drugplain

Acetaminophen and Diphenhydramine hydrochloride 500 mg/1

Acetaminophen and Diphenhydramine hydrochloride · TABLET · Aurohealth LLC

No Recall HistoryCurrently in Shortage
Plain English

Acetaminophen and Diphenhydramine hydrochloride is a tablet containing acetaminophen and diphenhydramine hydrochloride at 500 mg/1, taken oral. Manufactured by Aurohealth LLC.

Key Facts

Brand Name
Acetaminophen and Diphenhydramine hydrochloride
Generic Name
Acetaminophen and Diphenhydramine hydrochloride
NDC Code (Product)
58602-760
Manufacturer
Aurohealth LLC
Strength
500 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
01/05/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

completed suicide158 reports
toxicity to various agents127 reports
death34 reports
cardio-respiratory arrest28 reports
intentional product misuse25 reports
pain25 reports
drug ineffective24 reports
fatigue24 reports
joint swelling20 reports
somnolence20 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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

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.

Frequently Asked Questions

What is Acetaminophen and Diphenhydramine hydrochloride used for?

Acetaminophen and Diphenhydramine hydrochloride contains Acetaminophen and Diphenhydramine hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.

Is Acetaminophen and Diphenhydramine hydrochloride a controlled substance?

Acetaminophen and Diphenhydramine hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Acetaminophen and Diphenhydramine hydrochloride?

The generic name for Acetaminophen and Diphenhydramine hydrochloride is Acetaminophen and Diphenhydramine hydrochloride. There are 10 other brand versions of Acetaminophen and Diphenhydramine hydrochloride.

What is the NDC code for Acetaminophen and Diphenhydramine hydrochloride 500 mg/1?

The NDC (National Drug Code) for Acetaminophen and Diphenhydramine hydrochloride 500 mg/1 is 58602-760, listed by Aurohealth LLC.

Product NDC

58602-760

Package NDC

58602-760-14

Other Acetaminophen and Diphenhydramine hydrochloride Dosages

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)