Drugplain

Severe Congestion and Pain 325 mg/1

Acetaminophen, Guaifenesin, Phenylephrine HCl · TABLET, FILM COATED · Family Dollar Services Inc

No Recall HistoryCurrently in Shortage
Plain English

Severe Congestion and Pain is a tablet, film coated containing acetaminophen, guaifenesin, phenylephrine hcl at 325 mg/1, taken oral. Manufactured by Family Dollar Services Inc.

Key Facts

Brand Name
Severe Congestion and Pain
Generic Name
Acetaminophen, Guaifenesin, Phenylephrine HCl
NDC Code (Product)
55319-815
Manufacturer
Family Dollar Services Inc
Strength
325 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
12/13/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

death2 reports
abdominal pain1 reports
application site vesicles1 reports
aspartate aminotransferase increased1 reports
back pain1 reports
blood potassium increased1 reports
blood pressure increased1 reports
cardio-respiratory arrest1 reports
chest pain1 reports
completed suicide1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves: nasal congestion headache minor aches and pains sinus congestion and pressure promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage & Administration

Directions do not take more than directed (see Overdose warning ) do not take more than 12 caplets in any 24-hour period adults and children 12 years and older: take 2 caplets every 4 hours children under 12 years of age: do not use

Warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 12 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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. Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchi…

Frequently Asked Questions

What is Severe Congestion and Pain used for?

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

Is Severe Congestion and Pain a controlled substance?

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

What is the generic name for Severe Congestion and Pain?

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

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

The NDC (National Drug Code) for Severe Congestion and Pain 325 mg/1 is 55319-815, listed by Family Dollar Services Inc.

Product NDC

55319-815

Package NDC

55319-815-19

Other Severe Congestion and Pain 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)