Drugplain

Severe Sinus Congestion and Pain 325 mg/1

Acetaminophen, Guaifenesin, Phenylephrine · TABLET, COATED · Shield Pharmaceuticals Corp

No Recall HistoryCurrently in Shortage
Plain English

Severe Sinus Congestion and Pain is a tablet, coated containing acetaminophen, guaifenesin, phenylephrine at 325 mg/1, taken oral. Manufactured by Shield Pharmaceuticals Corp.

Key Facts

Brand Name
Severe Sinus Congestion and Pain
Generic Name
Acetaminophen, Guaifenesin, Phenylephrine
NDC Code (Product)
83059-0057
Manufacturer
Shield Pharmaceuticals Corp
Strength
325 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
10/30/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

cardio-respiratory arrest1 reports
completed suicide1 reports
death1 reports
inappropriate schedule of product administration1 reports
off label use1 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 reaction occurs, stop use and seek medical help right away.

Frequently Asked Questions

What is Severe Sinus Congestion and Pain used for?

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

Is Severe Sinus Congestion and Pain a controlled substance?

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

What is the generic name for Severe Sinus Congestion and Pain?

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

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

The NDC (National Drug Code) for Severe Sinus Congestion and Pain 325 mg/1 is 83059-0057, listed by Shield Pharmaceuticals Corp.