Mucinex Fast-Max Cold, Flu and Sore Throat

Description

Mucinex® FAST-MAX® is a maximum strength formulation designed for the relief of cold, flu, and sore throat symptoms. Each dosage form consists of fast dissolving liquid gels, specifically formulated for daytime use in individuals aged 12 and older. The product contains the following active ingredients: acetaminophen, which serves as a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; guaifenesin, an expectorant; and phenylephrine HCl, a nasal decongestant. The product is packaged in a container containing 16 liquid gels, each being a liquid-filled capsule. The National Drug Code (NDC) for this product is 72854-127-16.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, sore throat, and fever. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the expulsion of mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage to avoid potential overdose. The maximum allowable dosage is 12 liquid gels within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 liquid gels every 4 hours as needed. It is imperative that patients do not exceed the specified dosage within the given time frame.

This medication is not indicated for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration 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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use during the course of MAOI therapy and for a period of 2 weeks following the cessation of MAOI treatment. 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 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 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 develop; or if a cough recurs or is accompanied by fever, rash, or headache lasting longer than expected, 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 drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. In cases of overdose, which may result from taking more than the recommended dose, immediate medical assistance should be sought, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be aware that acetaminophen may lead to severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. If any skin reaction occurs, it is imperative to discontinue use and seek medical help immediately. Additionally, if 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 doctor promptly.

Patients with liver disease, heart disease, diabetes, high blood pressure, thyroid disease, or those experiencing trouble urinating due to an enlarged prostate gland should consult a healthcare professional before using this product. Furthermore, individuals with persistent or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. It is important for patients taking the blood-thinning medication warfarin to consult a doctor or pharmacist before using this product.

Patients are advised to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, 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 arise; or if a cough recurs or occurs with fever, rash, or headache that persists, as these may indicate a serious condition.

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, 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 used for at least two weeks following the discontinuation of an MAOI, as this may lead to serious adverse effects.

Patients taking the anticoagulant warfarin should consult 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 increase the risk of bleeding.

Packaging & NDC

Below are the non-prescription pack sizes of Mucinex Fast-Max Cold, Flu and Sore Throat (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, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, are included in the general population for whom this product is indicated. The product is approved for use in adults and children aged 12 years and older.

While there are no specific dosage adjustments or safety concerns outlined for geriatric patients, it is essential for healthcare providers to exercise caution. Elderly patients may have comorbid conditions that could influence the safety and efficacy of the product. Therefore, it is advisable to consult a healthcare professional prior to use if the patient has a history of liver disease, heart disease, diabetes, high blood pressure, thyroid disease, or urinary difficulties due to an enlarged prostate gland.

Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the variability in drug metabolism and response among elderly patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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. This precaution is essential to ensure safe and effective use of the medication in individuals with reduced kidney function.

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

Overdosage may result in significant liver damage, particularly when the recommended dosage is exceeded. It is imperative that healthcare professionals remain vigilant regarding the potential consequences of overdose.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Prompt intervention is crucial, as the risk of serious complications exists for both adults and children, even in the absence of noticeable signs or symptoms.

Timely medical attention can be critical in managing the effects of an overdose and mitigating potential harm.

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

While using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should encourage 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 use. 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 for identification. 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, Flu and Sore Throat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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