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Mucinex Sinus-Max

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Active ingredient
Oxymetazoline Hydrochloride 0.05 g/100 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Solution
Route
Nasal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
February 8, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride 0.05 g/100 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Solution
Route
Nasal
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
February 8, 2024
Manufacturer
RB Health (US) LLC
Registration number
M012
NDC root
63824-129
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Mucinex® SINUS-MAX® is a nasal spray that contains oxymetazoline HCl (a medication that helps relieve nasal congestion) at a concentration of 0.05%. It is classified as a nasal decongestant and is designed to temporarily relieve nasal congestion caused by colds, hay fever, or other upper respiratory allergies. This product works by promoting nasal and sinus drainage, relieving sinus congestion and pressure, and helping to clear nasal passages by shrinking swollen membranes.

This fast-acting nasal spray provides relief that lasts for up to 12 hours and features a cooling menthol flavor for added comfort. It is available in a 22 mL (3/4 FL OZ) bottle, making it easy to use whenever you need to breathe more easily.

Uses

If you're dealing with nasal congestion from a cold, hay fever, or other upper respiratory allergies, this medication can help provide temporary relief. It works by promoting drainage in your nasal passages and sinuses, which can ease the pressure and discomfort you might be feeling.

Additionally, this medication helps to clear your nasal passages by shrinking swollen membranes, making it easier for you to breathe. Whether you're facing seasonal allergies or a common cold, this treatment can support your comfort and help you feel better.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. If you are an adult or a child aged 6 to under 12 years, you can use 2 or 3 sprays in each nostril. Just remember not to use it more often than every 10 to 12 hours, and do not exceed 2 doses in a 24-hour period. If your child is under 6 years old, it’s important to consult a doctor before using this medication.

When you’re ready to spray, hold the bottle with your thumb at the base and your fingers on either side of the nozzle. Keep your head upright and insert the nozzle into your nostril. Press the pump down firmly and sniff deeply at the same time. After using the spray, make sure to wipe the nozzle clean to keep it hygienic.

What to Avoid

It's important to use this product responsibly to ensure your safety and well-being. You should never exceed the recommended dosage, as doing so can lead to unwanted effects. Additionally, avoid using this product for more than three days. Using it longer than directed may cause your nasal congestion to come back or even worsen.

Always follow the instructions provided and use the product only as directed to minimize any potential risks. If you have any concerns or questions about your use of this product, consider consulting a healthcare professional for guidance.

Side Effects

Using this product may lead to some temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. If you use it frequently or for a long time, you might notice that nasal congestion could come back or even get worse.

If your symptoms continue, it's important to stop using the product and consult a doctor. Additionally, be cautious: sharing this product with others can spread infections, and if you accidentally swallow it, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

Before using this product, it's important to consult your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. Always follow the recommended dosage and do not use this product for more than three days, as overuse can lead to worsening nasal congestion. You may experience temporary discomfort, such as burning, stinging, sneezing, or increased nasal discharge. Additionally, sharing this product with others can spread infections.

Keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. If your symptoms do not improve, stop using the product and reach out to your doctor for further advice.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When using this medication for children aged 6 to under 12 years, you can administer 2 or 3 sprays in each nostril, but make sure to do this no more than every 10 to 12 hours. It's important not to exceed 2 doses in a 24-hour period. For children under 6 years old, you should consult a doctor before use to ensure safety and proper guidance. Always supervise your child during administration to ensure they are using the medication correctly.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

No further information is available.

FAQ

What is Mucinex® SINUS-MAX®?

Mucinex® SINUS-MAX® is a nasal spray that contains Oxymetazoline HCl 0.05% and is classified as a nasal decongestant.

How does Mucinex® SINUS-MAX® work?

It temporarily relieves nasal congestion due to colds, hay fever, or other upper respiratory allergies, promotes nasal and sinus drainage, and helps clear nasal passages by shrinking swollen membranes.

How long does the effect of Mucinex® SINUS-MAX® last?

The effects of Mucinex® SINUS-MAX® last for up to 12 hours.

What is the recommended dosage for adults and children aged 6 to under 12?

Adults and children aged 6 to under 12 should use 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours, and should not exceed 2 doses in any 24-hour period.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Mucinex® SINUS-MAX®.

What are the possible side effects of using Mucinex® SINUS-MAX®?

Possible side effects include temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.

How should I use Mucinex® SINUS-MAX®?

Shake well before use, hold the bottle with your thumb at the base and the nozzle between your first and second fingers, insert the nozzle into your nostril, and fully depress the pump while sniffing deeply.

What precautions should I take when using Mucinex® SINUS-MAX®?

Do not exceed the recommended dosage, do not use for more than 3 days, and avoid sharing the container with others to prevent spreading infection.

What should I do if symptoms persist?

If symptoms persist, stop using Mucinex® SINUS-MAX® and consult a doctor.

Is there any contraindication for using Mucinex® SINUS-MAX®?

There are no explicit contraindications mentioned for Mucinex® SINUS-MAX®.

Packaging Info

Below are the non-prescription pack sizes of Mucinex Sinus-Max (oxymetazoline hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucinex Sinus-Max.
Details

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.

View product document (PDF)

Description

Mucinex® SINUS-MAX® is a nasal spray formulated to provide severe nasal congestion relief. Each 3/4 FL OZ (22 mL) bottle contains oxymetazoline hydrochloride at a concentration of 0.05%, serving as a nasal decongestant. The product is designed for fast-acting relief that lasts up to 12 hours. It features a cooling menthol flavor, enhancing the user experience with a clear and cool sensation. The National Drug Code (NDC) for this formulation is 63824-129-17.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with a cold, hay fever, or other upper respiratory allergies. It promotes nasal and sinus drainage and provides temporary relief from sinus congestion and pressure. Additionally, this drug helps to clear nasal passages by shrinking swollen membranes.

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

Dosage and Administration

Adults and children aged 6 to under 12 years of age, when administered under adult supervision, may receive 2 or 3 sprays in each nostril. Dosing should not occur more frequently than every 10 to 12 hours, and it is imperative not to exceed 2 doses within a 24-hour period. For children under 6 years of age, consultation with a healthcare professional is recommended prior to use.

Prior to administration, the bottle should be shaken well. For proper application, the healthcare professional should instruct the patient to hold the bottle with the thumb at the base and the nozzle positioned between the first and second fingers. The patient should insert the nozzle into the nostril without tilting the head, fully depress the pump with a firm, even stroke, and sniff deeply to ensure effective delivery of the medication. After use, the nozzle should be wiped clean to maintain hygiene and prevent contamination.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage or utilize it for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. It is essential to adhere strictly to the directed usage guidelines to avoid potential complications.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product. Prior to use, it is imperative to consult a physician if the patient has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland.

When utilizing this product, adherence to the recommended dosage is crucial. Patients should not exceed the prescribed amount or use the product for more than three consecutive days. It is essential to follow the directions provided, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. Users may experience temporary discomfort, which can manifest as burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is important to note that sharing this product among multiple users may facilitate the spread of infection.

In the event of accidental ingestion, the product should be kept out of reach of children. Immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Patients should be instructed to discontinue use and consult a physician if symptoms persist.

Side Effects

Patients using this product may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. It is important to note that frequent or prolonged use of the product may lead to a recurrence or worsening of nasal congestion.

Patients are advised to stop using the product and consult a healthcare professional if symptoms persist. Additionally, the use of this container by more than one person may pose a risk of spreading infection. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Mucinex Sinus-Max (oxymetazoline hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mucinex Sinus-Max.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. It is important to note that the total dosage should not exceed 2 doses within a 24-hour period. For children under 6 years of age, consultation with a healthcare professional is advised prior to use.

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 safe use during pregnancy and lactation.

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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and 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.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if symptoms persist. When using this product, it is essential to adhere to the recommended dosage and not to use it for more than three days. Emphasize that the product should only be used as directed, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Inform patients that they may experience temporary discomfort while using the product, which can include burning, stinging, sneezing, or an increase in nasal discharge. Additionally, caution patients that the use of this container by more than one person may facilitate the spread of infection.

Healthcare providers should also encourage patients to consult a doctor before using this product if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to enlargement of the prostate gland.

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) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

No further data are available.

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.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Mucinex Sinus-Max, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.