Drugplain

Theraflu ExpressMax Daytime Severe Cold and Cough 325 mg/1

acetaminophen, dextromethorphan HBr, phenylephrine HCl · TABLET, FILM COATED · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage
Plain English

Theraflu Expressmax Daytime Severe Cold and Cough is an over-the-counter oral tablet that combines acetaminophen (pain reliever/fever reducer), dextromethorphan (cough suppressant), and phenylephrine (decongestant) to help relieve multiple cold and cough symptoms. This medication is designed for daytime use to address severe cold symptoms including pain, fever, cough, and nasal congestion.

Key Facts

Brand Name
Theraflu ExpressMax Daytime Severe Cold and Cough
Generic Name
acetaminophen, dextromethorphan HBr, phenylephrine HCl
NDC Code (Product)
0067-8136
Manufacturer
Haleon US Holdings LLC
Strength
325 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
07/05/2016

Recall History

No Recall History

Side Effects Reported to FDA

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

product quality issue4 reports
drug ineffective3 reports
dyspnoea3 reports
illness3 reports
cough2 reports
discomfort2 reports
drug hypersensitivity2 reports
fatigue2 reports
feeling abnormal2 reports
loss of consciousness2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these symptoms due to a cold: minor aches and pains minor sore throat pain headache nasal and sinus congestion cough due to minor throat and bronchial irritation 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 4 hours, while symptoms persist. Do not take more than 10 caplets in 24 hours unless directed by a doctor. children under 12 years of age: do not use

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe lever 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 for 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 d…

Frequently Asked Questions

What is Theraflu ExpressMax Daytime Severe Cold and Cough used for?

Theraflu Expressmax Daytime Severe Cold and Cough is an over-the-counter oral tablet that combines acetaminophen (pain reliever/fever reducer), dextromethorphan (cough suppressant), and phenylephrine (decongestant) to help relieve multiple cold and cough symptoms. This medication is designed for daytime use to address severe cold symptoms including pain, fever, cough, and nasal congestion.

Is Theraflu ExpressMax Daytime Severe Cold and Cough a controlled substance?

Theraflu ExpressMax Daytime Severe Cold and Cough is not classified as a controlled substance by the DEA.

What is the generic name for Theraflu ExpressMax Daytime Severe Cold and Cough?

The generic name for Theraflu ExpressMax Daytime Severe Cold and Cough is acetaminophen, dextromethorphan HBr, phenylephrine HCl. There are 12 other brand versions of acetaminophen, dextromethorphan HBr, phenylephrine HCl.

What is the NDC code for Theraflu ExpressMax Daytime Severe Cold and Cough 325 mg/1?

The NDC (National Drug Code) for Theraflu ExpressMax Daytime Severe Cold and Cough 325 mg/1 is 0067-8136, listed by Haleon US Holdings LLC.

Product NDC

0067-8136

Package NDC

0067-8136-10

Other Acetaminophen, Brands

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

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