Drugplain

Theraflu Flu Relief Max Strength Daytime 1000 mg/1

Acetaminophen, Dextromethorphan HBr · POWDER · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage
Plain English

Theraflu Flu Relief Max Strength Daytime is a powder containing acetaminophen, dextromethorphan hbr at 1000 mg/1, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
Theraflu Flu Relief Max Strength Daytime
Generic Name
Acetaminophen, Dextromethorphan HBr
NDC Code (Product)
0067-7921
Manufacturer
Haleon US Holdings LLC
Strength
1000 mg/1
Dosage Form
POWDER
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
06/15/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

loss of consciousness2 reports
somnolence2 reports
anxiety1 reports
confusional state1 reports
dizziness1 reports
drug ineffective1 reports
heart rate increased1 reports
palpitations1 reports
presyncope1 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 • measure the dose correctly using the enclosed dosing cup • adults and children 12 years of age and over: take every 6 hours in dosing cup provided, while symptoms persist • do not take more than 3 doses (90 mL) 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 30 mL 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 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 t

Frequently Asked Questions

What is Theraflu Flu Relief Max Strength Daytime used for?

Theraflu Flu Relief Max Strength Daytime contains Acetaminophen, Dextromethorphan HBr. It is a powder taken oral. Consult your doctor for specific uses.

Is Theraflu Flu Relief Max Strength Daytime a controlled substance?

Theraflu Flu Relief Max Strength Daytime is not classified as a controlled substance by the DEA.

What is the generic name for Theraflu Flu Relief Max Strength Daytime?

The generic name for Theraflu Flu Relief Max Strength Daytime is Acetaminophen, Dextromethorphan HBr. There are 12 other brand versions of Acetaminophen, Dextromethorphan HBr.

What is the NDC code for Theraflu Flu Relief Max Strength Daytime 1000 mg/1?

The NDC (National Drug Code) for Theraflu Flu Relief Max Strength Daytime 1000 mg/1 is 0067-7921, listed by Haleon US Holdings LLC.