Drugplain

Cold and Head Congestion Severe 325 mg/1

ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE · TABLET, COATED · TopCo Associates LLC

No Recall HistoryCurrently in Shortage
Plain English

Cold and Head Congestion 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 nasal congestion). It is used to temporarily relieve multiple cold and flu symptoms including fever, aches, congestion, and cough.

Key Facts

Brand Name
Cold and Head Congestion Severe
Generic Name
ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
NDC Code (Product)
36800-575
Manufacturer
TopCo Associates LLC
Strength
325 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
06/30/2017

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 for the temporary relief of the following cold symptoms: minor aches and pains headache sore throat 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 (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. Sore throat warning If sore throat is severe, perists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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 thi…

Frequently Asked Questions

What is Cold and Head Congestion Severe used for?

Cold and Head Congestion 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 nasal congestion). It is used to temporarily relieve multiple cold and flu symptoms including fever, aches, congestion, and cough.

Is Cold and Head Congestion Severe a controlled substance?

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

What is the generic name for Cold and Head Congestion Severe?

The generic name for Cold and Head Congestion 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 Cold and Head Congestion Severe 325 mg/1?

The NDC (National Drug Code) for Cold and Head Congestion Severe 325 mg/1 is 36800-575, listed by TopCo Associates LLC.

Product NDC

36800-575

Package NDC

36800-575-02

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)