Drugplain

Mucinex Fast-Max Cold, Flu and Sore Throat 650 mg/20mL

acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride · SOLUTION · Reckitt Benckiser LLC

No Recall HistoryCurrently in Shortage
Plain English

Mucinex Fast-Max Cold, Flu and Sore Throat is a solution containing acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride at 650 mg/20mL, taken oral. Manufactured by Reckitt Benckiser LLC.

Key Facts

Brand Name
Mucinex Fast-Max Cold, Flu and Sore Throat
Generic Name
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
NDC Code (Product)
63824-015
Manufacturer
Reckitt Benckiser LLC
Strength
650 mg/20mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
02/07/2012

Recall History

No Recall History

Side Effects Reported to FDA

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

dizziness8 reports
dyspnoea6 reports
hallucination5 reports
loss of consciousness5 reports
overdose5 reports
anxiety4 reports
expired product administered4 reports
headache4 reports
oropharyngeal pain4 reports
blood pressure increased3 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses ■ temporarily relieves these common cold and flu symptoms: ■ minor aches and pains ■ headache ■ sore throat ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily reduces fever

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 of age 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 for this product ■ 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. 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. Ask a doctor before use if you have ■ liver disease ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed Stop use and…

Frequently Asked Questions

What is Mucinex Fast-Max Cold, Flu and Sore Throat used for?

Mucinex Fast-Max Cold, Flu and Sore Throat contains acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride. It is a solution taken oral. Consult your doctor for specific uses.

Is Mucinex Fast-Max Cold, Flu and Sore Throat a controlled substance?

Mucinex Fast-Max Cold, Flu and Sore Throat is not classified as a controlled substance by the DEA.

What is the generic name for Mucinex Fast-Max Cold, Flu and Sore Throat?

The generic name for Mucinex Fast-Max Cold, Flu and Sore Throat is acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride. There are 11 other brand versions of acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride.

What is the NDC code for Mucinex Fast-Max Cold, Flu and Sore Throat 650 mg/20mL?

The NDC (National Drug Code) for Mucinex Fast-Max Cold, Flu and Sore Throat 650 mg/20mL is 63824-015, listed by Reckitt Benckiser LLC.

Product NDC

63824-015

Package NDC

63824-015-66

Other Mucinex Fast-Max Cold, Flu and Sore Throat Dosages

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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)