Drugplain

Theraflu ExpressMax Nighttime Severe Cold and Cough 650 mg/30mL

Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl · SYRUP · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage
Plain English

Theraflu ExpressMax Nighttime Severe Cold and Cough is a syrup containing acetaminophen, diphenhydramine hcl, phenylephrine hcl at 650 mg/30mL, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
Theraflu ExpressMax Nighttime Severe Cold and Cough
Generic Name
Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
NDC Code (Product)
0067-8129
Manufacturer
Haleon US Holdings LLC
Strength
650 mg/30mL
Dosage Form
SYRUP
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
07/15/2015

Recall History

No Recall History

Side Effects Reported to FDA

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

dyspnoea5 reports
cough3 reports
drug ineffective3 reports
fatigue3 reports
malaise3 reports
nasopharyngitis3 reports
nausea3 reports
product quality issue3 reports
asthma2 reports
constipation2 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 runny nose sneezing itchy nose or throat itchy, watery eyes due to hay fever 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. with any other product containing diphenhydramine, even one used on the skin 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 con

Frequently Asked Questions

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

Theraflu ExpressMax Nighttime Severe Cold and Cough contains Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl. It is a syrup taken oral. Consult your doctor for specific uses.

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

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

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

The generic name for Theraflu ExpressMax Nighttime Severe Cold and Cough is Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl. There are 10 other brand versions of Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl.

What is the NDC code for Theraflu ExpressMax Nighttime Severe Cold and Cough 650 mg/30mL?

The NDC (National Drug Code) for Theraflu ExpressMax Nighttime Severe Cold and Cough 650 mg/30mL is 0067-8129, listed by Haleon US Holdings LLC.