Drugplain

Tylenol PM 500 mg/1

ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE · TABLET, FILM COATED · JC World Bell Wholesale Co., Inc.

1 Recall on RecordCurrently in Shortage
Plain English

Tylenol PM is a tablet, film coated containing acetaminophen, diphenhydramine hydrochloride at 500 mg/1, taken oral. Manufactured by JC World Bell Wholesale Co., Inc..

Key Facts

Brand Name
Tylenol PM
Generic Name
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
NDC Code (Product)
50269-608
Manufacturer
JC World Bell Wholesale Co., Inc.
Strength
500 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
08/16/2018

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

fatigue436 reports
nausea355 reports
diarrhoea287 reports
dizziness256 reports
drug ineffective246 reports
insomnia237 reports
pain237 reports
headache228 reports
asthenia204 reports
vomiting204 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 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 if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma 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 drinks do not drive a motor vehicle or

Frequently Asked Questions

What is Tylenol PM used for?

Tylenol PM contains ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Tylenol PM a controlled substance?

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

What is the generic name for Tylenol PM?

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

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

The NDC (National Drug Code) for Tylenol PM 500 mg/1 is 50269-608, listed by JC World Bell Wholesale Co., Inc..