Drugplain

TYLENOL SINUS PLUS HEADACHE DAY 325 mg/1

Acetaminophen and Phenylephrine hydrochloride · TABLET, FILM COATED · Kenvue Brands LLC

No Recall HistoryCurrently in Shortage
Plain English

Tylenol Sinus Plus Headache Day is an over-the-counter tablet that combines acetaminophen (a pain reliever and fever reducer) with phenylephrine (a decongestant) to help relieve sinus pressure, congestion, and headache symptoms. This combination medication is taken by mouth and is available without a prescription.

Key Facts

Brand Name
TYLENOL SINUS PLUS HEADACHE DAY
Generic Name
Acetaminophen and Phenylephrine hydrochloride
NDC Code (Product)
50580-598
Manufacturer
Kenvue Brands LLC
Strength
325 mg/1
Dosage Form
TABLET, FILM COATED
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

foetal exposure during pregnancy3 reports
autism spectrum disorder2 reports
blood pressure increased2 reports
headache2 reports
drug ineffective1 reports
dyspepsia1 reports
exposure during pregnancy1 reports
gastrointestinal haemorrhage1 reports
hepatomegaly1 reports
inappropriate schedule of product administration1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: headache sinus congestion and pressure nasal congestion minor aches and pains helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole; do not crush, chew or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

Warnings

Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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. Do not use 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. if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver disease heart disease high blood pressu…

Frequently Asked Questions

What is TYLENOL SINUS PLUS HEADACHE DAY used for?

Tylenol Sinus Plus Headache Day is an over-the-counter tablet that combines acetaminophen (a pain reliever and fever reducer) with phenylephrine (a decongestant) to help relieve sinus pressure, congestion, and headache symptoms. This combination medication is taken by mouth and is available without a prescription.

Is TYLENOL SINUS PLUS HEADACHE DAY a controlled substance?

TYLENOL SINUS PLUS HEADACHE DAY is not classified as a controlled substance by the DEA.

What is the generic name for TYLENOL SINUS PLUS HEADACHE DAY?

The generic name for TYLENOL SINUS PLUS HEADACHE DAY is Acetaminophen and Phenylephrine hydrochloride. There are 12 other brand versions of Acetaminophen and Phenylephrine hydrochloride.

What is the NDC code for TYLENOL SINUS PLUS HEADACHE DAY 325 mg/1?

The NDC (National Drug Code) for TYLENOL SINUS PLUS HEADACHE DAY 325 mg/1 is 50580-598, listed by Kenvue Brands LLC.

Product NDC

50580-598

Package NDC

50580-598-02

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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)