Mucinex Sinus-Max

Description

Mucinex® SINUS-MAX® is a maximum strength formulation designed to address severe congestion and pain. Each dosage form consists of 16 fast dissolving liquid gels, which are liquid-filled capsules. The active ingredients include acetaminophen, a pain reliever; dextromethorphan HBr, a cough suppressant; and phenylephrine HCl, a nasal decongestant. This combination effectively clears sinus congestion, relieves headache, and controls cough. The product is indicated for daytime use in individuals aged 12 years and older. The National Drug Code (NDC) for this product is 63824-692-16.

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 temporarily promotes nasal and/or sinus drainage.

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:

• 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. This contraindication extends for 2 weeks following the discontinuation of an MAOI. 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 under certain conditions. Healthcare professionals should advise patients that the maximum daily dosage is 12 liquid gels within a 24-hour period. Patients must be cautioned against concurrent use with other medications containing acetaminophen, as well as the consumption of three or more alcoholic drinks daily while using this product.

Severe skin reactions have been associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. Should any of these reactions occur, patients are instructed to discontinue use immediately and seek medical assistance.

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

General precautions should be taken prior to use. Patients should 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, or emphysema. Additionally, patients with a cough that produces excessive phlegm should also seek medical advice. It is essential to inquire with a doctor or pharmacist before use if the patient is currently taking the anticoagulant warfarin.

Patients should be advised to stop taking the product and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice 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 with fever, rash, or headache that lasts. These symptoms may indicate a serious underlying condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage 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.

Participants are advised to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond 7 days, or if fever intensifies or lasts more than 3 days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by fever, rash, or a headache that lasts may indicate a serious condition requiring prompt evaluation.

An overdose warning is also pertinent; taking more than the recommended dose can lead to liver damage. In cases of suspected overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as timely medical intervention 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) for the treatment of depression, psychiatric disorders, or Parkinson's disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. The combination may lead to serious and potentially life-threatening interactions.

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 alterations in the anticoagulant effect.

Packaging & NDC

Below are the non-prescription pack sizes of Mucinex Sinus-Max (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.

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. 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 the safety of both the mother and the developing fetus.

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

Overdosage

In cases of overdose, the administration of doses exceeding the recommended amount may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential consequences of such an event.

Immediate medical assistance is crucial. In the event of an overdose, it is recommended that individuals seek medical help or contact a Poison Control Center without delay. This action is essential for both adults and children, as prompt intervention can mitigate the risk of severe complications.

Healthcare providers should be aware that symptoms of overdose may not always be immediately apparent. Therefore, even in the absence of noticeable signs or symptoms, it is vital to pursue quick medical attention to ensure the safety and well-being of the patient.

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. Patients and healthcare professionals 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 stopped taking an MAOI 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, 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 fever, rash, or a headache that lasts, as these may indicate a serious condition.

When using this product, patients should 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, or emphysema, should also seek medical advice before using this product. Furthermore, patients should be advised to consult a doctor if they have a cough that occurs with 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 is essential to store the product at a controlled temperature range 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 crucial to maintain the efficacy and safety of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 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. Additionally, it is important to keep the medication out of reach of children. 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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