Mucinex Fast-Max Cold and Flu

Description

MUCINEX® FAST-MAX® COLD & FLU is a maximum strength formulation designed for the relief of cold and flu symptoms. Each dosage form consists of fast dissolving liquid gels, specifically liquid-filled capsules, suitable for individuals aged 12 and older. The active ingredients include acetaminophen, which serves as a pain reliever and fever reducer, and dextromethorphan HBr, functioning as a cough suppressant. The product is identified by the National Drug Code (NDC) 72854-171.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including cough due to minor throat and bronchial irritation that may occur with the common cold or inhaled irritants. It is effective in reducing the intensity of coughing and the impulse to cough, which may assist in achieving sleep. Additionally, this drug alleviates minor aches and pains, sore throat, headache, and temporarily reduces fever.

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 recommended 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) for depression, psychiatric, or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of the MAOI. This is due to the potential for serious drug interactions. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

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. In the event of a skin reaction, 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 cases of 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 should seek guidance from a doctor or pharmacist if they are currently taking the anticoagulant warfarin. It is critical that patients adhere strictly to the recommended dosage and not exceed the directed amount.

Patients should be instructed to stop using the product and contact their healthcare provider if any of the following occur: pain or cough worsens or lasts longer than seven days; fever worsens or persists for more than three days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients taking this product, which contains acetaminophen, if they exceed the maximum daily amount of 12 liquid gels within a 24-hour period, use it concurrently with other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware that acetaminophen may cause severe skin reactions, which can 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 of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a doctor promptly.

Patients should not use this product in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Additionally, it should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. If there is uncertainty regarding the presence of an MAOI in a prescription drug, patients should consult a doctor or pharmacist.

Before using this product, patients should seek medical advice if they have liver disease, heart disease, diabetes, high blood pressure, thyroid disease, trouble urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist prior to use.

Patients are advised to stop use and consult a doctor if pain or cough worsens or lasts more than seven days, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms occur, or if cough recurs with a rash or headache that persists, as these may indicate a serious condition.

An overdose of this product may 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, as prompt 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 any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

Pharmacodynamic interactions should be considered when this medication is administered alongside monoamine oxidase inhibitors (MAOIs). It is advised that this medication not be used in conjunction with any MAOI, including those prescribed for depression, psychiatric disorders, or Parkinson's disease, and for a period of two weeks following the discontinuation of an MAOI.

Additionally, caution is warranted when this medication is used in patients taking warfarin, a blood-thinning agent. It is recommended that patients consult with a healthcare professional, such as a doctor or pharmacist, prior to use to assess the potential for increased bleeding risk and to determine if any dosage adjustments or monitoring are necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Mucinex Fast-Max Cold and Flu (acetaminophen, dextromethorphan hydrobromide). 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 cases of overdose, it is critical 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 require specific dosage adjustments or face unique safety concerns when using this product, as no such information is provided in the available data. The product is indicated for use in adults and children aged 12 years and older, indicating that it is not recommended for individuals under 12 years of age.

However, it is essential for healthcare providers to exercise caution and consider the potential for comorbidities commonly present in geriatric patients. Prior to use, it is advisable for elderly patients to consult with a healthcare professional, especially if they have underlying conditions such as liver disease, heart disease, diabetes, high blood pressure, thyroid disease, or urinary difficulties due to an enlarged prostate gland. These considerations are particularly relevant given the prevalence of multiple health issues in the elderly population, which may influence the safety and efficacy of the product.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding 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, particularly if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific condition.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. The formulation contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Specifically, patients should not exceed 12 liquid gels within a 24-hour period, as this represents the maximum daily dosage. Additionally, the concurrent use of other medications containing acetaminophen is contraindicated, as it may increase the risk of liver injury.

Patients consuming three or more alcoholic beverages daily while using this product are also at heightened risk for liver damage. It is crucial for patients to adhere strictly to the recommended dosage to avoid overdose, which can lead to significant liver harm. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. Prompt medical intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, there is a significant risk of liver damage. It is imperative that healthcare professionals recognize the seriousness of this condition and act swiftly.

Immediate medical assistance is crucial. In cases of suspected overdose, individuals should seek medical help or contact a Poison Control Center without delay. This is essential for both adults and children, as prompt intervention can mitigate potential complications.

Even in the absence of noticeable signs or symptoms, the need for quick medical attention cannot be overstated. Healthcare providers should ensure that patients and caregivers are aware of these critical steps to take in the event of an overdose, emphasizing the importance of vigilance and timely response.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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 or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if their pain or cough worsens or persists for more than 7 days, if their fever worsens or lasts more than 3 days, or if they notice any redness or swelling. They should also be advised to stop use and consult a doctor if new symptoms arise or if a cough returns, especially if accompanied by 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. Additionally, patients should be encouraged 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 experiencing a cough with excessive phlegm should consult a healthcare provider prior to use.

Lastly, patients taking the blood-thinning medication warfarin should be advised to speak with their doctor or pharmacist before using this product.

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, which may compromise the integrity of the product. Proper storage conditions are essential to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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