Mucinex Sinus-Max Severe Congestion and Pain

Description

Mucinex® Sinus-Max® is a maximum strength formulation designed for the relief of severe congestion and pain. Each dosage form consists of fast dissolving liquid gels, specifically formulated as liquid-filled capsules. The product contains the following active ingredients: acetaminophen, a pain reliever; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. The product is packaged with 16 liquid gels per unit. It is indicated for daytime use in individuals aged 12 years and older. The National Drug Code (NDC) for this product is 72854-203-16.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion, headache, minor aches and pains, sinus congestion and pressure, and cough. Additionally, it promotes nasal and/or sinus drainage on a temporary basis.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage to avoid the risk of 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.

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:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited 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.

The product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's Disease. Patients should verify with a healthcare professional if their current medications include an MAOI.

Additionally, exceeding the recommended dosage is contraindicated 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. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Overdose of acetaminophen can result in liver damage. In cases of suspected overdose, it is crucial to obtain medical help or contact a Poison Control Center without delay, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should advise patients to consult a doctor prior to use 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, or emphysema. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking the anticoagulant warfarin. It is important to adhere strictly to the recommended dosage and not exceed the directed amount.

Patients should be instructed to stop taking the product and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever intensifies or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs, particularly if accompanied by a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires further evaluation.

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.

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.

This product should not be used concurrently with any other drug containing acetaminophen, whether prescription or nonprescription. Patients are advised to consult a healthcare professional if uncertain about the presence of acetaminophen in their medications. Additionally, individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's Disease, or those who have stopped taking an MAOI within the past two weeks, should avoid this product.

Patients with pre-existing conditions such as liver disease, heart disease, diabetes, high blood pressure, thyroid disease, or urinary difficulties due to an enlarged prostate gland should consult a doctor prior to use. Furthermore, individuals experiencing a persistent or chronic cough, particularly those associated with smoking, asthma, or emphysema, or a cough accompanied by excessive phlegm, should also seek medical advice before using this product.

Patients taking the anticoagulant warfarin should consult a doctor or pharmacist before use.

Patients are advised to discontinue use and seek medical attention 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 a rash or headache lasting longer than usual, as these may indicate a serious condition.

An overdose of this product, characterized by taking more than the recommended dose, may lead to liver damage. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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 Sinus-Max Severe Congestion and Pain (acetaminophen, dextromethorphan hydrobromide, 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. Care should be taken to adhere to the specified age restrictions and dosing guidelines to ensure safety and efficacy in this population.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 drug 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 have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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. The risk of liver damage increases significantly with the intake of doses exceeding the recommended amount. In the event of an overdose, it is imperative that patients seek immediate medical assistance or contact a Poison Control Center. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Reports of side effects have been received through voluntary submissions and surveillance programs. Healthcare professionals and patients 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 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, especially if accompanied by a rash or a headache that lasts, as these may indicate a serious condition.

While using this product, patients should be reminded to adhere strictly to the recommended dosage and not exceed the directed amount. It is essential for patients to consult a doctor before using this medication 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, or emphysema, should also seek medical advice before use. Furthermore, patients should be advised to consult a doctor if they have a cough that produces excessive phlegm (mucus) or 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

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

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