Drugplain

Tylenol Sinus Severe 325 mg/1

Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride · TABLET, COATED · Morning Star OTC

No Recall HistoryCurrently in Shortage
Plain English

Tylenol Sinus Severe is a tablet, coated containing acetaminophen, guaifenesin, and phenylephrine hydrochloride at 325 mg/1, taken oral. Manufactured by Morning Star OTC.

Key Facts

Brand Name
Tylenol Sinus Severe
Generic Name
Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
NDC Code (Product)
53209-1004
Manufacturer
Morning Star OTC
Strength
325 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
06/19/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

inappropriate schedule of product administration4 reports
hypertension3 reports
nasopharyngitis3 reports
nausea3 reports
off label use3 reports
product dose omission issue3 reports
vomiting3 reports
decreased appetite2 reports
diarrhoea2 reports
dysgeusia2 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: sinus congestion and pressure headache nasal congestion minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 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 reactions occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompained or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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 …

Frequently Asked Questions

What is Tylenol Sinus Severe used for?

Tylenol Sinus Severe contains Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is Tylenol Sinus Severe a controlled substance?

Tylenol Sinus Severe is not classified as a controlled substance by the DEA.

What is the generic name for Tylenol Sinus Severe?

The generic name for Tylenol Sinus Severe is Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride. There are 12 other brand versions of Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride.

What is the NDC code for Tylenol Sinus Severe 325 mg/1?

The NDC (National Drug Code) for Tylenol Sinus Severe 325 mg/1 is 53209-1004, listed by Morning Star OTC.

Product NDC

53209-1004

Package NDC

53209-1004-2

Other Acetaminophen, Brands

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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)