Drugplain

Acetaminophen Diphenhydramine HCL 500 mg/1

Acetaminophen Diphenhydramine HCL · TABLET · WALGREENS CO.

No Recall HistoryCurrently in Shortage
Plain English

This over-the-counter tablet combines acetaminophen (a pain reliever and fever reducer) with diphenhydramine (an antihistamine that causes drowsiness) to help relieve minor aches, pains, and fever while promoting sleep. It's commonly used for nighttime pain relief when sleep disturbance is also a concern.

Key Facts

Brand Name
Acetaminophen Diphenhydramine HCL
Generic Name
Acetaminophen Diphenhydramine HCL
NDC Code (Product)
0363-9664
Manufacturer
WALGREENS CO.
Strength
500 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
09/30/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

disorientation1 reports
drug toxicity1 reports
malaise1 reports
product commingling1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the temporary relief of minor aches and pains associated with: sore throat headache muscular aches backache

Dosage & Administration

Directions take only as directed do not exceed 3 doses (30 mL each) per day (24 hours) only use the dose cup provided adults & children 12 yrs & over 30 mL every 6 hours children under 12 yrs ask a doctor

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 3 doses (30 mL each) in 24 hours, 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. 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. 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. Ask a doctor before use if you have liver disease a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a se

Frequently Asked Questions

What is Acetaminophen Diphenhydramine HCL used for?

This over-the-counter tablet combines acetaminophen (a pain reliever and fever reducer) with diphenhydramine (an antihistamine that causes drowsiness) to help relieve minor aches, pains, and fever while promoting sleep. It's commonly used for nighttime pain relief when sleep disturbance is also a concern.

Is Acetaminophen Diphenhydramine HCL a controlled substance?

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

What is the generic name for Acetaminophen Diphenhydramine HCL?

The generic name for Acetaminophen Diphenhydramine HCL is Acetaminophen Diphenhydramine HCL. There are 6 other brand versions of Acetaminophen Diphenhydramine HCL.

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

The NDC (National Drug Code) for Acetaminophen Diphenhydramine HCL 500 mg/1 is 0363-9664, listed by WALGREENS CO..