Drugplain

Sinus Congestion and Pain Severe 325 mg/1

ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE · TABLET, COATED · TopCare

No Recall HistoryCurrently in Shortage
Plain English

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

Key Facts

Brand Name
Sinus Congestion and Pain Severe
Generic Name
ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
NDC Code (Product)
36800-505
Manufacturer
TopCare
Strength
325 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
07/01/2013

Recall History

No Recall History

Side Effects Reported to FDA

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

abdominal pain upper1 reports
back pain1 reports
blister1 reports
diarrhoea1 reports
dyspnoea1 reports
erythema1 reports
hot flush1 reports
inappropriate schedule of product administration1 reports
off label use1 reports
pain of skin1 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 minor aches and pains nasal congestion sinus congestion and pressure 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 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. 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: blisters rash skin reddening 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 diabetes heart disease thyroid disease liver disease high blood pressure cough that occurs with too much phlegm (mucus) persistent or c…

Frequently Asked Questions

What is Sinus Congestion and Pain Severe used for?

Sinus Congestion and Pain Severe contains ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is Sinus Congestion and Pain Severe a controlled substance?

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

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

The generic name for Sinus Congestion and Pain 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 Sinus Congestion and Pain Severe 325 mg/1?

The NDC (National Drug Code) for Sinus Congestion and Pain Severe 325 mg/1 is 36800-505, listed by TopCare.

Product NDC

36800-505

Package NDC

36800-505-05

Other Acetaminophen, Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)