Drugplain

Pain Relief PM 500 mg/1

ACETAMINOPHEN, DIPHENHYDRAMINE · TABLET · Pioneer Life Sciences, LLC

No Recall HistoryCurrently in Shortage
Plain English

Pain Relief PM is an over-the-counter tablet that combines acetaminophen (a pain reliever and fever reducer) with diphenhydramine (an antihistamine that causes drowsiness) to help relieve minor aches and pains while promoting sleep. This combination is typically used for nighttime pain relief when sleep is also desired.

Key Facts

Brand Name
Pain Relief PM
Generic Name
ACETAMINOPHEN, DIPHENHYDRAMINE
NDC Code (Product)
72090-032
Manufacturer
Pioneer Life Sciences, LLC
Strength
500 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
08/29/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

completed suicide197 reports
toxicity to various agents151 reports
death50 reports
fatigue49 reports
pain40 reports
drug toxicity37 reports
drug ineffective34 reports
cardio-respiratory arrest32 reports
intentional product misuse32 reports
nausea28 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 (see overdose warning) adults and children 12 years and over ■ take 2 caplets at bedtime ■ do not take more than 2 caplets in 24 hours unless directed by a doctor ■ 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 hrs ■ 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.

Frequently Asked Questions

What is Pain Relief PM used for?

Pain Relief PM is an over-the-counter tablet that combines acetaminophen (a pain reliever and fever reducer) with diphenhydramine (an antihistamine that causes drowsiness) to help relieve minor aches and pains while promoting sleep. This combination is typically used for nighttime pain relief when sleep is also desired.

Is Pain Relief PM a controlled substance?

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

What is the generic name for Pain Relief PM?

The generic name for Pain Relief PM is ACETAMINOPHEN, DIPHENHYDRAMINE. There are 12 other brand versions of ACETAMINOPHEN, DIPHENHYDRAMINE.

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

The NDC (National Drug Code) for Pain Relief PM 500 mg/1 is 72090-032, listed by Pioneer Life Sciences, LLC.

Product NDC

72090-032

Package NDC

72090-032-01

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)