Mucinex Fast-Max

Description

Mucinex® FAST-MAX is a maximum strength formulation designed for the relief of cold, flu, and sore throat symptoms. Each package contains 16 fast dissolving liquid gels, which are liquid-filled capsules. The active ingredients include acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; guaifenesin, an expectorant; and phenylephrine HCl, a nasal decongestant. This product is intended for use by individuals aged 12 years and older. The National Drug Code (NDC) for this formulation is 63824-591-16.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including nasal congestion, headache, cough, minor aches and pains, and sore throat. Additionally, it temporarily reduces fever and aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the expulsion of bothersome mucus and enhancing the productivity of coughs.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage guidelines. For adults and children aged 12 years and older, the prescribed dosage is 2 liquid gels every 4 hours, with a maximum limit of 12 liquid gels within a 24-hour period.

It is imperative that patients do not exceed the directed dosage, as outlined in the Overdose warning. The use of this medication is not recommended for children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

• It is also advised to adhere strictly to the recommended dosage and not exceed the directed amount while using this product.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 12 liquid gels within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor promptly if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Overdosing on acetaminophen can result in liver damage. In the event of an overdose, immediate medical attention is crucial; patients should contact a Poison Control Center without delay, as rapid intervention is essential for both adults and children, even in the absence of noticeable symptoms.

General precautions should be taken prior to use. Patients should be advised to consult a healthcare provider if they have any of the following conditions: liver disease, heart disease, diabetes, high blood pressure, thyroid disease, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

Patients should be instructed to stop taking the product and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily amount of 12 liquid gels within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases where a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should also stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than seven days; if fever worsens or lasts more than three days; if redness or swelling is present; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that persists. These symptoms may indicate a serious condition.

An overdose warning is in place, as taking more than the recommended dose can lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately. Quick medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, it should not be administered within 2 weeks of discontinuing an MAOI, as this may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential interactions that could affect bleeding risk.

Packaging & NDC

Below are the non-prescription pack sizes of Mucinex Fast-Max (acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 liquid gels every 4 hours.

In the event of an overdose, it is crucial to seek quick medical attention for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use if they experience difficulty urinating due to an enlarged prostate gland. This precaution is essential to ensure appropriate management and monitoring of their condition, as reduced kidney function may influence the pharmacokinetics and safety profile of the medication.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily amount of 12 liquid gels within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with a history of liver disease consult a healthcare professional prior to use. Additionally, taking more than the recommended dose can lead to overdose, which may result in liver damage. In the event of an overdose, it is imperative that patients seek immediate medical assistance or contact a Poison Control Center, as prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

Taking more than the recommended dose may lead to significant liver damage. It is imperative that in the event of an overdose, immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay.

Quick medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Prompt intervention can mitigate potential complications associated with overdose and improve patient outcomes.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Reports of side effects have been received through voluntary submissions and surveillance programs. Individuals are encouraged to report any adverse events to the designated phone number provided for this purpose.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and consult a doctor if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. Patients should also be informed to seek medical attention if new symptoms arise or if a cough returns or occurs with a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. It is essential for patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, diabetes, high blood pressure, thyroid disease, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice before using this product. Furthermore, patients should be advised to consult a doctor or pharmacist if they are taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat to maintain product integrity.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is also important to keep the medication out of reach of children. Additionally, patients are encouraged to report any side effects experienced during postmarketing by contacting the designated phone number.

Drug Information (PDF)

This file contains official product information for Mucinex Fast-Max, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)