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Vicks Sinex Severe

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Active ingredient
Oxymetazoline Hydrochloride 0.0005095 g/1 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Spray
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
December 10, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride 0.0005095 g/1 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Spray
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
December 10, 2025
Manufacturer
Procter & Gamble Manufacturing GmbH
Registration number
M012
NDC root
64336-170
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

VICKS Sinex™ SEVERE is a nasal decongestant spray that contains oxymetazoline HCl. It is designed to temporarily relieve nasal congestion caused by colds, hay fever, or other upper respiratory allergies. Additionally, it helps alleviate sinus congestion and pressure, providing fast relief that lasts for up to 12 hours.

This product also features powerful Vicks vapors, enhancing your comfort during times of congestion. If you're experiencing discomfort from nasal or sinus congestion, VICKS Sinex™ SEVERE may be a helpful option to consider for temporary relief.

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 easing the swelling in your nasal passages, making it easier for you to breathe.

Additionally, if you're experiencing sinus congestion and pressure, this medication can also help alleviate those uncomfortable symptoms. It's designed to give you some comfort when you're feeling under the weather.

Dosage and Administration

If you are an adult or a child aged 6 years and older (with adult supervision), you can use this medication by spraying 2 or 3 sprays into each nostril. Make sure to wait at least 10 to 12 hours before using it again, and do not take more than 2 doses in a 24-hour period to ensure safety.

For children aged 2 to under 6 years, it’s important to consult a doctor before use. If your child is under 2 years old, this medication should not be used at all. Always follow these guidelines to ensure proper and safe use of the medication.

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 in a row. Prolonged use may cause nasal congestion to return or worsen, which can be uncomfortable.

Always follow the directions provided to minimize the risk of misuse or complications. If you have any questions or concerns about how to use this product safely, please consult a healthcare professional.

Side Effects

If you have heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate, it's important to consult your doctor before using this medication.

You should also stop using the medication and reach out to your doctor if your symptoms do not improve. Your health and safety are the top priority, so don't hesitate to seek guidance if you have any concerns.

Warnings and Precautions

Before using this medication, it’s important to consult your doctor if you have any of the following conditions: heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. These conditions may affect how the medication works for you.

If you notice that your symptoms do not improve or if they persist, you should stop taking the medication and contact your doctor for further advice. Always prioritize your health and seek professional guidance when needed.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember to use medications as directed by your healthcare provider to minimize the risk of 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 it comes to using this medication for children, there are specific guidelines to follow. For children aged 6 years and older, you can administer 2 or 3 sprays in each nostril, but make sure not to do this more often than every 10 to 12 hours. It's important to limit the total to 2 doses within a 24-hour period, and adult supervision is recommended during use.

For younger children, the recommendations differ. If your child is between 2 and under 6 years old, it's best to consult with a doctor before using this medication. For children under 2 years, you should avoid using it altogether. Always prioritize safety and seek professional advice when it comes to your child's health.

Geriatric Use

While there is no specific information about the use of Vicks Sinex Severe Original Nasal Spray in older adults, it's always important to approach any medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide personalized advice based on your health needs and any other medications you may be taking.

Remember, as you age, your body may process medications differently, so it's wise to ensure that any treatment is safe and appropriate for you.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and ensure the best possible care for your health.

Storage and Handling

To ensure the safety and effectiveness of your product, it’s important to store it at a temperature that does not exceed 25ºC (77ºF). Keeping it within this temperature range helps maintain its quality and performance.

When handling the product, make sure to do so with care to avoid any damage. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

You should use this medication through your nose (nasal administration). For adults and children aged 6 years and older, the recommended dose is 2 or 3 sprays in each nostril, but you should not 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 between 2 and under 6 years old, consult a doctor before use. This medication is not recommended for children under 2 years old.

FAQ

What is VICKS Sinex™ SEVERE?

VICKS Sinex™ SEVERE is an oxymetazoline HCl nasal decongestant available as an original nasal spray, designed to temporarily relieve nasal and sinus congestion.

How does VICKS Sinex™ SEVERE work?

It temporarily relieves nasal congestion due to colds, hay fever, or other upper respiratory allergies, and also alleviates sinus congestion and pressure.

Who can use VICKS Sinex™ SEVERE?

Adults and children 6 years and older can use it with adult supervision. Children under 2 years should not use it, and those aged 2 to under 6 years should ask a doctor.

What is the recommended dosage for adults and children 6 years and older?

The recommended dosage is 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours, and do not exceed 2 doses in 24 hours.

Are there any warnings for using VICKS Sinex™ SEVERE?

Yes, you should ask a doctor before use if you have heart disease, thyroid disease, diabetes, high blood pressure, or trouble urinating due to an enlarged prostate gland.

What should I do if symptoms persist?

You should stop using VICKS Sinex™ SEVERE and ask a doctor if your symptoms persist.

Can I use VICKS Sinex™ SEVERE if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this product.

How long can I use VICKS Sinex™ SEVERE?

You should not use this product for more than 3 days and only as directed to avoid worsening nasal congestion.

What are the possible side effects of VICKS Sinex™ SEVERE?

Temporary discomfort such as burning, stinging, sneezing, or increased nasal discharge may occur.

Packaging Info

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

Packaging configurations for Vicks Sinex Severe.
Details

Drug Information (PDF)

This file contains official product information for Vicks Sinex Severe, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with colds, hay fever, or other upper respiratory allergies. Additionally, it provides temporary relief from sinus congestion and pressure.

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

Dosage and Administration

For adults and children aged 6 years and older, the recommended dosage is 2 to 3 sprays in each nostril. Dosing should not occur more frequently than every 10 to 12 hours, and it is important not to exceed 2 doses within a 24-hour period.

For children aged 2 to under 6 years, it is advised to consult a physician for appropriate dosing recommendations.

The product is not indicated for use in children under 2 years of age; therefore, it should not be administered to this age group.

Contraindications

Use of this product is contraindicated in the following situations:

  • Exceeding the recommended dosage is contraindicated due to the potential for adverse effects.

  • Prolonged use beyond 3 days is contraindicated, as it may lead to the recurrence or worsening of nasal congestion. This product should only be used as directed.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a history of any of the following conditions: heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. These conditions may increase the risk of adverse effects or complications associated with the medication.

In the event that symptoms persist despite use, patients are advised to discontinue the medication and seek medical advice promptly. This precaution is essential to ensure appropriate management and to rule out any underlying conditions that may require further evaluation.

Side Effects

Patients should be advised to consult a healthcare professional prior to use if they have a history of heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

In the event that symptoms persist, patients are instructed to discontinue use and seek medical advice. This precaution is essential to ensure the safety and well-being of individuals with underlying health conditions.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Vicks Sinex Severe.
Details

Pediatric Use

Pediatric patients aged 6 years and older may receive 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. It is important not to exceed 2 doses within a 24-hour period, and this should be done under adult supervision.

For children aged 2 to under 6 years, consultation with a healthcare provider is recommended prior to use. The product is contraindicated in children under 2 years of age.

Geriatric Use

There is no specific information regarding the use of Vicks Sinex Severe Original Nasal Spray in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment efficacy and safety in 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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

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 this patient population.

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 available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions thoroughly, as this information may be vital for ongoing patient management and for reporting purposes.

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 limits the assessment of potential risks associated with the use of the compound in question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be instructed to stop using the product and consult a doctor if symptoms persist.

When using this product, it is essential to emphasize that patients must not exceed the recommended dosage and should not use it for more than three days. They should use the product only as directed, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. Patients may experience temporary discomfort, including burning, stinging, sneezing, or increased nasal discharge.

Additionally, healthcare providers should inform patients that the use of this container by more than one person may increase the risk of spreading infection.

Patients should be encouraged to consult a doctor before using this product if they have any of the following conditions: heart disease, thyroid disease, diabetes, high blood pressure, or trouble urinating due to an enlarged 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 temperature not exceeding 25ºC to maintain its integrity and efficacy. Proper container requirements must be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs should be observed to prevent any compromise to the product's quality during storage and transportation.

Additional Clinical Information

The medication is administered via the nasal route. For adults and children aged 6 years and older, the recommended dosage is 2 or 3 sprays in each nostril, with a frequency not exceeding every 10 to 12 hours, and a maximum of 2 doses within a 24-hour period. For children aged 2 to under 6 years, consultation with a doctor is advised before use, while the medication is not recommended for children under 2 years of age.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Vicks Sinex Severe, 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 Vicks Sinex Severe, 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.