Drugplain

Panadol Cold and Flu Day 500 mg/1

acetaminophen, dextromethorphan HBr · TABLET · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage
Plain English

Panadol Cold and Flu Day is a tablet containing acetaminophen, dextromethorphan hbr at 500 mg/1, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
Panadol Cold and Flu Day
Generic Name
acetaminophen, dextromethorphan HBr
NDC Code (Product)
0135-7033
Manufacturer
Haleon US Holdings LLC
Strength
500 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
04/30/2026

Recall History

No Recall History

Side Effects Reported to FDA

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

fatigue337 reports
nausea327 reports
pyrexia306 reports
pain299 reports
headache292 reports
dyspnoea280 reports
off label use262 reports
confusional state242 reports
diarrhoea229 reports
vomiting227 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily relieves these symptoms due to a common cold or flu: headache minor aches and pains cough due to minor throat and bronchial irritation minor sore throat pain temporarily reduces fever

Dosage & Administration

Directions do not use more than directed adults and children 12 years of age and over: take 2 caplets every 6 hours, while symptoms persist do not take more than 6 caplets in 24 hours unless directed by a doctor children under 12 years of age: do not use Age Dose adults and children 12 years of age and over 2 caplets every 6 hours children under 12 years of age 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. Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. Do not use in a child under 12 years of age if you are allergic to acetaminophen 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 now taking a prescription monoamine oxidase inhibitor (MAOI)(certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor

Frequently Asked Questions

What is Panadol Cold and Flu Day used for?

Panadol Cold and Flu Day contains acetaminophen, dextromethorphan HBr. It is a tablet taken oral. Consult your doctor for specific uses.

Is Panadol Cold and Flu Day a controlled substance?

Panadol Cold and Flu Day is not classified as a controlled substance by the DEA.

What is the generic name for Panadol Cold and Flu Day?

The generic name for Panadol Cold and Flu Day is acetaminophen, dextromethorphan HBr. There are 12 other brand versions of acetaminophen, dextromethorphan HBr.

What is the NDC code for Panadol Cold and Flu Day 500 mg/1?

The NDC (National Drug Code) for Panadol Cold and Flu Day 500 mg/1 is 0135-7033, listed by Haleon US Holdings LLC.