Drugplain

Panadol Cold and Flu NonDrowsy 325 mg/1

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

No Recall HistoryCurrently in Shortage
Plain English

Panadol Cold and Flu NonDrowsy is a tablet, film coated containing acetaminophen and phenyleprine hcl at 325 mg/1, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
Panadol Cold and Flu NonDrowsy
Generic Name
acetaminophen and phenyleprine HCl
NDC Code (Product)
0135-0607
Manufacturer
Haleon US Holdings LLC
Strength
325 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
06/01/2017

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 state241 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 the common cold or flu: nasal congestion stuffy nose sore throat headache sinus congestion and pressure minor aches and pains 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 4 hours, while symptoms persist or as directed by a doctor do not take more than 12 caplets in 24 hours, unless directed by a doctor children under 12 years of age: ask a doctor swallow whole – do not crush, chew or dissolve

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, 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. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, ask a doctor promptly. 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 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. if you are allergic to acetaminophen or any of

Frequently Asked Questions

What is Panadol Cold and Flu NonDrowsy used for?

Panadol Cold and Flu NonDrowsy contains acetaminophen and phenyleprine HCl. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Panadol Cold and Flu NonDrowsy a controlled substance?

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

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

The generic name for Panadol Cold and Flu NonDrowsy is acetaminophen and phenyleprine HCl. There are no other listed brand versions of acetaminophen and phenyleprine HCl.

What is the NDC code for Panadol Cold and Flu NonDrowsy 325 mg/1?

The NDC (National Drug Code) for Panadol Cold and Flu NonDrowsy 325 mg/1 is 0135-0607, listed by Haleon US Holdings LLC.

Product NDC

0135-0607

Package NDC

0135-0607-02

Other Panadol Cold and Flu NonDrowsy Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)