Drugplain

PANADOL PM 500 mg/1

acetaminophen and diphenhydramine HCl · TABLET, FILM COATED · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage
Plain English

PANADOL PM is a tablet, film coated containing acetaminophen and diphenhydramine hcl at 500 mg/1, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
PANADOL PM
Generic Name
acetaminophen and diphenhydramine HCl
NDC Code (Product)
0135-0608
Manufacturer
Haleon US Holdings LLC
Strength
500 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
12/01/2016

Recall History

No Recall History

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 of age and over: take 2 caplets at bedtime, if needed, or as directed by a doctor do not give to children under 12 years of age

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 are allergic to acetaminophen or any of the inactive ingredients in this product Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin sedatives or tranquilizers When using this product drowsiness will occur avoid alcoholic drinks be careful when driving a motor v

Adverse Reactions

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.

Frequently Asked Questions

What is PANADOL PM used for?

PANADOL PM contains acetaminophen and diphenhydramine HCl. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is PANADOL PM a controlled substance?

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

What is the generic name for PANADOL PM?

The generic name for PANADOL PM is acetaminophen and diphenhydramine HCl. There are 6 other brand versions of acetaminophen and diphenhydramine HCl.

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

The NDC (National Drug Code) for PANADOL PM 500 mg/1 is 0135-0608, listed by Haleon US Holdings LLC.