Mucinex Sinus-Max

Description

Mucinex® Sinus-Max® is a maximum strength formulation designed for daytime use, available in the form of fast dissolving liquid gels. Each package contains 16 liquid-filled capsules. The active ingredients include acetaminophen, which serves as a pain reliever; dextromethorphan HBr, functioning as a cough suppressant; guaifenesin, an expectorant; and phenylephrine HCl, a nasal decongestant. This product is indicated for individuals aged 12 years and older. The National Drug Code (NDC) for this formulation is 63824-693-16.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion, headache, minor aches and pains, cough, and sinus congestion and pressure. It also promotes nasal and/or sinus drainage and assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance 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 taken every 4 hours as needed.

It is important to note that this medication is not indicated for use in children under 12 years of age.

Contraindications

The 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. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any doubt about the presence of an MAOI in a current prescription, a healthcare professional should be consulted prior to use.

Additionally, it is essential to adhere 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.

Overdose of acetaminophen can result in significant liver damage. In the event of an overdose, it is crucial to obtain medical help or contact a Poison Control Center without delay. Prompt medical attention is essential for both adults and children, even if no immediate signs or symptoms are apparent.

Healthcare professionals should advise patients to consult a physician 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, chronic bronchitis, or emphysema. Additionally, patients should be cautioned to 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 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 with fever, 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 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.

This product should not be used concurrently with any other drug containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in their medications are advised to consult a doctor or pharmacist. Additionally, individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or 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 those experiencing trouble urinating due to an enlarged prostate gland should consult a doctor before use. Furthermore, individuals with a persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema, as well as those with a cough that produces excessive phlegm, should also seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin should 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 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 with fever, rash, or headache lasting longer than expected, 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 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 any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric disorders, or Parkinson's disease. Additionally, it should not be administered for at least two weeks following the discontinuation of an MAOI to avoid serious interactions.

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 warranted to ensure safe use and to mitigate the risk of altered anticoagulant effects.

Packaging & NDC

Below are the non-prescription pack sizes of Mucinex Sinus-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 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

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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 imperative that patients with liver disease consult a healthcare professional prior to use. The risk of liver damage increases significantly with the ingestion of doses exceeding the recommended amount. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent.

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 promptly.

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 timely intervention can mitigate potential complications.

Healthcare providers should be aware that symptoms may not be immediately apparent, and even in the absence of noticeable signs, the risk of serious health consequences remains. Therefore, proactive management and monitoring are advised to ensure patient safety and effective treatment.

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 past 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, or if fever worsens or lasts more than three days. Patients should also be informed 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 should 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 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 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, as this 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, with the recommended dosage for adults and children aged 12 years and older being 2 liquid gels every 4 hours. It is advised that this medication not be used in children under 12 years of age. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding and to ensure that the medication is kept out of reach of children.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

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