Drugplain

Theraflu-D Flu Relief Max Strength plus Nasal Decongestant 1000 mg/30mL

Acetaminophen, Dextromethorphan HBr, Pseudoephedrine HCl · SYRUP · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage
Plain English

Theraflu-D Flu Relief Max Strength plus Nasal Decongestant is a syrup containing acetaminophen, dextromethorphan hbr, pseudoephedrine hcl at 1000 mg/30mL, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant
Generic Name
Acetaminophen, Dextromethorphan HBr, Pseudoephedrine HCl
NDC Code (Product)
0067-0115
Manufacturer
Haleon US Holdings LLC
Strength
1000 mg/30mL
Dosage Form
SYRUP
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
06/19/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

drug effective for unapproved indication2 reports
product use in unapproved indication2 reports
product taste abnormal1 reports
somnolence1 reports
therapeutic product effect incomplete1 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 minor sore throat pain runny nose cough due to minor throat and bronchial irritation nasal and sinus congestion 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 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 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-D Flu Relief Max Strength plus Nasal Decongestant used for?

Theraflu-D Flu Relief Max Strength plus Nasal Decongestant contains Acetaminophen, Dextromethorphan HBr, Pseudoephedrine HCl. It is a syrup taken oral. Consult your doctor for specific uses.

Is Theraflu-D Flu Relief Max Strength plus Nasal Decongestant a controlled substance?

Theraflu-D Flu Relief Max Strength plus Nasal Decongestant is not classified as a controlled substance by the DEA.

What is the generic name for Theraflu-D Flu Relief Max Strength plus Nasal Decongestant?

The generic name for Theraflu-D Flu Relief Max Strength plus Nasal Decongestant is Acetaminophen, Dextromethorphan HBr, Pseudoephedrine HCl. There are no other listed brand versions of Acetaminophen, Dextromethorphan HBr, Pseudoephedrine HCl.

What is the NDC code for Theraflu-D Flu Relief Max Strength plus Nasal Decongestant 1000 mg/30mL?

The NDC (National Drug Code) for Theraflu-D Flu Relief Max Strength plus Nasal Decongestant 1000 mg/30mL is 0067-0115, listed by Haleon US Holdings LLC.

Product NDC

0067-0115

Package NDC

0067-0115-01

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

Data from openFDA · Public domain (CC0 1.0)