Drugplain

PANADOL Extra Strength 500 mg/1

acetaminophen · TABLET, FILM COATED · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage
Plain English

PANADOL Extra Strength is a tablet, film coated containing acetaminophen at 500 mg/1, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
PANADOL Extra Strength
Generic Name
acetaminophen
NDC Code (Product)
0135-0609
Manufacturer
Haleon US Holdings LLC
Strength
500 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
03/15/2017

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves minor aches and pains due to: headache muscular aches backache minor arthritis pain temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see overdose warning) adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist or as directed by a doctor do not take more than 8 caplets in 24 hours, unless directed by a doctor children under 12 years of age: ask a doctor

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hours, which is the maximum daily amount 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. 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 Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: Takin

Frequently Asked Questions

What is PANADOL Extra Strength used for?

PANADOL Extra Strength contains acetaminophen. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is PANADOL Extra Strength a controlled substance?

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

What is the generic name for PANADOL Extra Strength?

The generic name for PANADOL Extra Strength is acetaminophen. There are 12 other brand versions of acetaminophen.

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

The NDC (National Drug Code) for PANADOL Extra Strength 500 mg/1 is 0135-0609, listed by Haleon US Holdings LLC.