Pain Reliever PM 500 mg/1

Acetaminophen Diphenhydramine HCl · TABLET, COATED · QUALITY CHOICE (Chain Drug Marketing Association)

1 Recall on RecordCurrently in Shortage

Plain English

Pain Reliever PM is a tablet, coated containing acetaminophen diphenhydramine hcl at 500 mg/1, taken oral. Manufactured by QUALITY CHOICE (Chain Drug Marketing Association).

Key Facts

Brand Name: Pain Reliever PM
Generic Name: Acetaminophen Diphenhydramine HCl
NDC Code (Product): 83324-166
Manufacturer: QUALITY CHOICE (Chain Drug Marketing Association)
Strength: 500 mg/1
Dosage Form: TABLET, COATED
Route: ORAL
Marketing Status
Application #: M012
Marketing Start: 07/31/2024

Recall History

1 Recall on Record

Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

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

pain28 reports

fatigue27 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 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 used for?

Pain Reliever PM contains Acetaminophen Diphenhydramine HCl. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is Pain Reliever PM a controlled substance?

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

What is the generic name for Pain Reliever PM?

The generic name for Pain Reliever PM is Acetaminophen Diphenhydramine HCl. There are 8 other brand versions of Acetaminophen Diphenhydramine HCl.

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

The NDC (National Drug Code) for Pain Reliever PM 500 mg/1 is 83324-166, listed by QUALITY CHOICE (Chain Drug Marketing Association).

Product NDC

83324-166

Package NDC

83324-166-50

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

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