Drugplain

Cold and Head Congestion Severe 325 mg/1

Acetaminophen, Guaifenesin, Phenylephrine HCl · TABLET, FILM COATED · Meijer Distribution, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Cold and Head Congestion Severe is a tablet, film coated containing acetaminophen, guaifenesin, phenylephrine hcl at 325 mg/1, taken oral. Manufactured by Meijer Distribution, Inc..

Key Facts

Brand Name
Cold and Head Congestion Severe
Generic Name
Acetaminophen, Guaifenesin, Phenylephrine HCl
NDC Code (Product)
79481-3572
Manufacturer
Meijer Distribution, Inc.
Strength
325 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
09/10/2024

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

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, Phenylephrine HCl. There are 11 other brand versions of Acetaminophen, Guaifenesin, Phenylephrine HCl.

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 79481-3572, listed by Meijer Distribution, Inc..

Product NDC

79481-3572

Package NDC

79481-3572-8

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)