Drugplain

Theraflu Severe Cold Relief Soft Chews 325 mg/1

Acetaminophen, Dextromethorphan HBr · TABLET, CHEWABLE · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage
Plain English

Theraflu Severe Cold Relief Soft Chews is an over-the-counter chewable tablet containing acetaminophen (a pain reliever and fever reducer) and dextromethorphan (a cough suppressant) used to relieve multiple cold symptoms. Each chewable tablet contains 325 mg of acetaminophen and 1 mg of dextromethorphan hydrobromide.

Key Facts

Brand Name
Theraflu Severe Cold Relief Soft Chews
Generic Name
Acetaminophen, Dextromethorphan HBr
NDC Code (Product)
0067-0111
Manufacturer
Haleon US Holdings LLC
Strength
325 mg/1
Dosage Form
TABLET, CHEWABLE
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 ineffective12 reports
anxiety7 reports
dyspnoea7 reports
fatigue7 reports
feeling abnormal6 reports
influenza6 reports
nasopharyngitis6 reports
nausea6 reports
pain6 reports
vomiting6 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 ▪ sore throat pain ▪ headache ▪ cough due to minor throat and bronchial irritation ▪ temporarily reduces fever

Dosage & Administration

Directions ▪ do not use more than directed ▪ do not take more than 10 chewable tablets in 24 hours unless directed by a doctor. Take every 4 hours, while symptoms persist. Age Dose adults and children 12 years of age and over take 2 chewable tablets every 4 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 t…

Frequently Asked Questions

What is Theraflu Severe Cold Relief Soft Chews used for?

Theraflu Severe Cold Relief Soft Chews is an over-the-counter chewable tablet containing acetaminophen (a pain reliever and fever reducer) and dextromethorphan (a cough suppressant) used to relieve multiple cold symptoms. Each chewable tablet contains 325 mg of acetaminophen and 1 mg of dextromethorphan hydrobromide.

Is Theraflu Severe Cold Relief Soft Chews a controlled substance?

Theraflu Severe Cold Relief Soft Chews is not classified as a controlled substance by the DEA.

What is the generic name for Theraflu Severe Cold Relief Soft Chews?

The generic name for Theraflu Severe Cold Relief Soft Chews is Acetaminophen, Dextromethorphan HBr. There are 11 other brand versions of Acetaminophen, Dextromethorphan HBr.

What is the NDC code for Theraflu Severe Cold Relief Soft Chews 325 mg/1?

The NDC (National Drug Code) for Theraflu Severe Cold Relief Soft Chews 325 mg/1 is 0067-0111, listed by Haleon US Holdings LLC.

Product NDC

0067-0111

Package NDC

0067-0111-01

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

Data from openFDA · Public domain (CC0 1.0)