Drugplain

Sinus Severe 325 mg/1

Acetaminophen, Guaifenesin, Phenylephrine HCl · TABLET, FILM COATED · Strategic Sourcing Services LLC

2 Recalls on RecordCurrently in Shortage
Plain English

Sinus Severe is an over-the-counter tablet that combines acetaminophen (a pain reliever and fever reducer), guaifenesin (an expectorant to help clear mucus), and phenylephrine (a decongestant) to relieve sinus congestion and related symptoms. This combination medication is taken by mouth and is commonly used to help manage sinus pressure, congestion, and discomfort associated with colds or sinus conditions.

Key Facts

Brand Name
Sinus Severe
Generic Name
Acetaminophen, Guaifenesin, Phenylephrine HCl
NDC Code (Product)
70677-1259
Manufacturer
Strategic Sourcing Services LLC
Strength
325 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
12/06/2024

Recall History

2 Recalls on Record
Class II12/26/2025

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

OngoingVoluntary: Firm initiated
Class II10/26/2021

Perrigo Company PLC

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

nausea90 reports
fatigue88 reports
pain80 reports
dyspnoea73 reports
drug ineffective71 reports
diarrhoea69 reports
headache61 reports
cough53 reports
off label use52 reports
anxiety49 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 upper 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 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 Sinus Severe used for?

Sinus Severe is an over-the-counter tablet that combines acetaminophen (a pain reliever and fever reducer), guaifenesin (an expectorant to help clear mucus), and phenylephrine (a decongestant) to relieve sinus congestion and related symptoms. This combination medication is taken by mouth and is commonly used to help manage sinus pressure, congestion, and discomfort associated with colds or sinus conditions.

Is Sinus Severe a controlled substance?

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

What is the generic name for Sinus Severe?

The generic name for Sinus Severe is Acetaminophen, Guaifenesin, Phenylephrine HCl. There are 11 other brand versions of Acetaminophen, Guaifenesin, Phenylephrine HCl.

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

The NDC (National Drug Code) for Sinus Severe 325 mg/1 is 70677-1259, listed by Strategic Sourcing Services LLC.

Product NDC

70677-1259

Package NDC

70677-1259-1

Other Sinus Severe Dosages

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)