Drugplain

Theraflu Severe Cold Relief Nighttime 650 mg/1

ACETAMINOPHEN, DIPHENHYDRAMINE HCl · POWDER, FOR SOLUTION · Haleon US Holdings LLC

No Recall HistoryCurrently in Shortage
Plain English

Theraflu Severe Cold Relief Nighttime is a powder, for solution containing acetaminophen, diphenhydramine hcl at 650 mg/1, taken oral. Manufactured by Haleon US Holdings LLC.

Key Facts

Brand Name
Theraflu Severe Cold Relief Nighttime
Generic Name
ACETAMINOPHEN, DIPHENHYDRAMINE HCl
NDC Code (Product)
0067-0101
Manufacturer
Haleon US Holdings LLC
Strength
650 mg/1
Dosage Form
POWDER, FOR SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
12/01/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective14 reports
dyspnoea7 reports
anxiety6 reports
fatigue6 reports
feeling abnormal6 reports
influenza6 reports
nasopharyngitis6 reports
nausea6 reports
pain6 reports
dizziness5 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 take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use dissolve contents of one packet into 8 oz. hot water; sip while hot. Consumer entire drink within 10-15 minutes. if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

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. 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 Severe Cold Relief Nighttime used for?

Theraflu Severe Cold Relief Nighttime contains ACETAMINOPHEN, DIPHENHYDRAMINE HCl. It is a powder, for solution taken oral. Consult your doctor for specific uses.

Is Theraflu Severe Cold Relief Nighttime a controlled substance?

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

What is the generic name for Theraflu Severe Cold Relief Nighttime?

The generic name for Theraflu Severe Cold Relief Nighttime is ACETAMINOPHEN, DIPHENHYDRAMINE HCl. There are 11 other brand versions of ACETAMINOPHEN, DIPHENHYDRAMINE HCl.

What is the NDC code for Theraflu Severe Cold Relief Nighttime 650 mg/1?

The NDC (National Drug Code) for Theraflu Severe Cold Relief Nighttime 650 mg/1 is 0067-0101, listed by Haleon US Holdings LLC.

Product NDC

0067-0101

Package NDC

0067-0101-06

Other Theraflu Severe Cold Relief Nighttime Dosages

Other Acetaminophen, Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)