Drugplain

Tylenol PM Extra Strength, CVP HEALTH 500 mg/1

Acetaminophen and Diphenhydramine Hydrochloride · TABLET, FILM COATED · Lil' Drug Store Products, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Tylenol PM Extra Strength, CVP HEALTH is a tablet, film coated containing acetaminophen and diphenhydramine hydrochloride at 500 mg/1, taken oral. Manufactured by Lil' Drug Store Products, Inc..

Key Facts

Brand Name
Tylenol PM Extra Strength, CVP HEALTH
Generic Name
Acetaminophen and Diphenhydramine Hydrochloride
NDC Code (Product)
66715-6517
Manufacturer
Lil' Drug Store Products, Inc.
Strength
500 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
05/06/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

completed suicide158 reports
toxicity to various agents127 reports
death34 reports
cardio-respiratory arrest28 reports
intentional product misuse25 reports
pain25 reports
drug ineffective24 reports
fatigue24 reports
joint swelling20 reports
somnolence20 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 Extra Strength, CVP HEALTH used for?

Tylenol PM Extra Strength, CVP HEALTH contains Acetaminophen and Diphenhydramine Hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Tylenol PM Extra Strength, CVP HEALTH a controlled substance?

Tylenol PM Extra Strength, CVP HEALTH is not classified as a controlled substance by the DEA.

What is the generic name for Tylenol PM Extra Strength, CVP HEALTH?

The generic name for Tylenol PM Extra Strength, CVP HEALTH is Acetaminophen and Diphenhydramine Hydrochloride. There are 12 other brand versions of Acetaminophen and Diphenhydramine Hydrochloride.

What is the NDC code for Tylenol PM Extra Strength, CVP HEALTH 500 mg/1?

The NDC (National Drug Code) for Tylenol PM Extra Strength, CVP HEALTH 500 mg/1 is 66715-6517, listed by Lil' Drug Store Products, Inc..