Drugplain

Sudafed PE Sinus Pressure Plus Pain 325 mg/1

Acetaminophen and Phenylephrine hydrochloride · TABLET, FILM COATED · Sportpharm LLC

No Recall HistoryCurrently in Shortage
Plain English

Sudafed Pe Sinus Pressure Plus Pain 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 associated pain. It is taken by mouth and is available without a prescription.

Key Facts

Brand Name
Sudafed PE Sinus Pressure Plus Pain
Generic Name
Acetaminophen and Phenylephrine hydrochloride
NDC Code (Product)
85766-183
Manufacturer
Sportpharm LLC
Strength
325 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
03/10/2026

Recall History

No Recall History

Side Effects Reported to FDA

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

gastric ulcer1 reports
incorrect dose administered1 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 minor aches and pains nasal congestion promotes sinus drainage temporarily reduces fever

Dosage & Administration

Directions do not use more than directed (see overdose warning ) adults and children 12 years and over take 2 tablets every 4 hours do not take more than 10 tablets 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 tablets (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 pressur…

Frequently Asked Questions

What is Sudafed PE Sinus Pressure Plus Pain used for?

Sudafed Pe Sinus Pressure Plus Pain 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 associated pain. It is taken by mouth and is available without a prescription.

Is Sudafed PE Sinus Pressure Plus Pain a controlled substance?

Sudafed PE Sinus Pressure Plus Pain is not classified as a controlled substance by the DEA.

What is the generic name for Sudafed PE Sinus Pressure Plus Pain?

The generic name for Sudafed PE Sinus Pressure Plus Pain is Acetaminophen and Phenylephrine hydrochloride. There are 10 other brand versions of Acetaminophen and Phenylephrine hydrochloride.

What is the NDC code for Sudafed PE Sinus Pressure Plus Pain 325 mg/1?

The NDC (National Drug Code) for Sudafed PE Sinus Pressure Plus Pain 325 mg/1 is 85766-183, listed by Sportpharm LLC.

Product NDC

85766-183

Package NDC

85766-183-24

Other Sudafed PE Sinus Pressure Plus Pain Dosages

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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)