Drugplain

Pain Reliever PM Extra Strength 500 mg/1

Acetaminophen, Diphenhydramine HCl · TABLET, FILM COATED · Salado Sales, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Pain Reliever PM Extra Strength is an over-the-counter tablet containing acetaminophen (a pain reliever and fever reducer) and diphenhydramine (a sleep aid), used to relieve minor aches and pains while helping you fall asleep. Each tablet contains 500 mg of acetaminophen and 1 mg of diphenhydramine.

Key Facts

Brand Name
Pain Reliever PM Extra Strength
Generic Name
Acetaminophen, Diphenhydramine HCl
NDC Code (Product)
57243-235
Manufacturer
Salado Sales, Inc.
Strength
500 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
05/15/1994

Recall History

No Recall History

Side Effects Reported to FDA

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

anhedonia1 reports
anterior chamber fibrin1 reports
anxiety1 reports
blood pressure abnormal1 reports
chills1 reports
corneal oedema1 reports
diarrhoea1 reports
disorientation1 reports
drug toxicity1 reports
dyspnoea1 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 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 any other product containing diphenhydramine, even one used on skin in children under 12 years of age with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis liver disease glaucoma difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product avoid alcoholic beverages drowsiness will occur do not drive a…

Frequently Asked Questions

What is Pain Reliever PM Extra Strength used for?

Pain Reliever PM Extra Strength is an over-the-counter tablet containing acetaminophen (a pain reliever and fever reducer) and diphenhydramine (a sleep aid), used to relieve minor aches and pains while helping you fall asleep. Each tablet contains 500 mg of acetaminophen and 1 mg of diphenhydramine.

Is Pain Reliever PM Extra Strength a controlled substance?

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

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

The generic name for Pain Reliever PM Extra Strength is Acetaminophen, Diphenhydramine HCl. There are 10 other brand versions of Acetaminophen, Diphenhydramine HCl.

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

The NDC (National Drug Code) for Pain Reliever PM Extra Strength 500 mg/1 is 57243-235, listed by Salado Sales, Inc..

Product NDC

57243-235

Package NDC

57243-235-15

Other Pain Reliever PM Extra Strength Dosages

Other Acetaminophen, Brands

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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)