Drugplain

Pain Reliever PM Extra Strength 500 mg/1

Acetaminophen, Diphenhydramine HCL · TABLET, COATED · Strategic Sourcing Services LLC

No Recall HistoryCurrently in Shortage
Plain English

Pain Reliever PM Extra Strength is a tablet, coated containing acetaminophen, diphenhydramine hcl at 500 mg/1, taken oral. Manufactured by Strategic Sourcing Services LLC.

Key Facts

Brand Name
Pain Reliever PM Extra Strength
Generic Name
Acetaminophen, Diphenhydramine HCL
NDC Code (Product)
62011-0420
Manufacturer
Strategic Sourcing Services LLC
Strength
500 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
11/29/2019

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 contains Acetaminophen, Diphenhydramine HCL. It is a tablet, coated taken oral. Consult your doctor for specific uses.

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 62011-0420, listed by Strategic Sourcing Services LLC.

Product NDC

62011-0420

Package NDC

62011-0420-1

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)