Drugplain

Extra Strength Pain Relief PM 500 mg/1

Acetaminophen and Diphenhydramine Hydrochloride · TABLET, COATED · VALU MERCHANDISERS COMPANY

No Recall HistoryCurrently in Shortage
Plain English

Extra Strength Pain Relief PM is a tablet, coated containing acetaminophen and diphenhydramine hydrochloride at 500 mg/1, taken oral. Manufactured by VALU MERCHANDISERS COMPANY.

Key Facts

Brand Name
Extra Strength Pain Relief PM
Generic Name
Acetaminophen and Diphenhydramine Hydrochloride
NDC Code (Product)
63941-095
Manufacturer
VALU MERCHANDISERS COMPANY
Strength
500 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
02/01/2010

Recall History

No Recall History

Side Effects Reported to FDA

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

completed suicide164 reports
toxicity to various agents129 reports
death41 reports
cardio-respiratory arrest29 reports
fatigue27 reports
pain27 reports
intentional product misuse26 reports
drug ineffective25 reports
somnolence22 reports
joint swelling21 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 recommended (see overdose warning) adults and children 12 years and over take 2 caplets at bedtime do not take more than 2 caplets 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 more than 4,000 mg of acetaminophen in 24 hours 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 other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist with any product containing diphenhydramine, even one used on skin in children under 12 years of age if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease breathing problems such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle o

Frequently Asked Questions

What is Extra Strength Pain Relief PM used for?

Extra Strength Pain Relief PM contains Acetaminophen and Diphenhydramine Hydrochloride. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is Extra Strength Pain Relief PM a controlled substance?

Extra Strength Pain Relief PM is not classified as a controlled substance by the DEA.

What is the generic name for Extra Strength Pain Relief PM?

The generic name for Extra Strength Pain Relief PM is Acetaminophen and Diphenhydramine Hydrochloride. There are 12 other brand versions of Acetaminophen and Diphenhydramine Hydrochloride.

What is the NDC code for Extra Strength Pain Relief PM 500 mg/1?

The NDC (National Drug Code) for Extra Strength Pain Relief PM 500 mg/1 is 63941-095, listed by VALU MERCHANDISERS COMPANY.