Drugplain

Cold Flu Severe 325 mg/1

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE · TABLET, COATED · HEB

1 Recall on RecordCurrently in Shortage
Plain English

Cold Flu Severe is a tablet, coated containing acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride at 325 mg/1, taken oral. Manufactured by HEB.

Key Facts

Brand Name
Cold Flu Severe
Generic Name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
NDC Code (Product)
37808-663
Manufacturer
HEB
Strength
325 mg/1
Dosage Form
TABLET, COATED
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
05/01/2018

Recall History

1 Recall on Record
Class II12/26/2025

GOLD STAR DISTRIBUTION INC

CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

OngoingVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the temporary relief of the following cold/flu symptoms: minor aches and pain headache sore throat nasal congestion cough 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, persists 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 th…

Frequently Asked Questions

What is Cold Flu Severe used for?

Cold Flu Severe contains ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is Cold Flu Severe a controlled substance?

Cold Flu Severe is not classified as a controlled substance by the DEA.

What is the generic name for Cold Flu Severe?

The generic name for Cold Flu Severe is ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE. There are 10 other brand versions of ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE.

What is the NDC code for Cold Flu Severe 325 mg/1?

The NDC (National Drug Code) for Cold Flu Severe 325 mg/1 is 37808-663, listed by HEB.

Product NDC

37808-663

Package NDC

37808-663-05

Other Cold Flu Severe 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)