Pain Relief PM Extra Strength 500 mg/1

Acetaminophen and Diphenhydramine Hydrochloride · TABLET, COATED · MARC GLASSMAN, INC.

No Recall HistoryCurrently in Shortage

Plain English

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

Key Facts

Brand Name: Pain Relief PM Extra Strength
Generic Name: Acetaminophen and Diphenhydramine Hydrochloride
NDC Code (Product): 68998-071
Manufacturer: MARC GLASSMAN, INC.
Strength: 500 mg/1
Dosage Form: TABLET, COATED
Route: ORAL
Marketing Status
Application #: M013
Marketing Start: 09/15/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

completed suicide160 reports

toxicity to various agents129 reports

death35 reports

cardio-respiratory arrest28 reports

fatigue26 reports

pain26 reports

intentional product misuse25 reports

drug ineffective24 reports

somnolence22 reports

nausea21 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 gelcaps at bedtime do not take more than 2 gelcaps 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin in children under 12 years of age Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis 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 drowsiness will occur avoid alcoholic beverages do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persi…

Frequently Asked Questions

What is Pain Relief PM Extra Strength used for?

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

Is Pain Relief PM Extra Strength a controlled substance?

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

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

The generic name for Pain Relief PM Extra Strength is Acetaminophen and Diphenhydramine Hydrochloride. There are 11 other brand versions of Acetaminophen and Diphenhydramine Hydrochloride.

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

The NDC (National Drug Code) for Pain Relief PM Extra Strength 500 mg/1 is 68998-071, listed by MARC GLASSMAN, INC..

Product NDC

68998-071

Package NDC

68998-071-03

Other Acetaminophen Brands

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

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