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Vicks Sinex Severe

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Active ingredient
Oxymetazoline Hydrochloride 0.05 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
October 1, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride 0.05 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
October 1, 2025
Manufacturer
Procter & Gamble Manufacturing GmbH
Registration number
M012
NDC root
64336-015
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 that contains oxymetazoline HCl, designed to provide temporary relief from nasal congestion caused by colds, hay fever, or other upper respiratory allergies. It also helps alleviate sinus congestion and pressure, making it easier for you to breathe comfortably.

This product features a moisturizing ultra-fine mist that includes soothing aloe and delivers powerful Vicks vapors for fast relief. With its 12-hour effectiveness, VICKS Sinex™ SEVERE can help you feel more at ease throughout the day.

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 a break from the discomfort associated with these common conditions.

Dosage and Administration

To use this medication, start by removing the protective cap from the nozzle. If this is your first time using it, you’ll need to prime the pump. Do this by pressing down on the rim several times until you see a fine mist. Next, hold the container with your thumb at the base and the nozzle between your first and second fingers.

When you’re ready to apply the spray, insert the nozzle into one nostril without tilting your head. Press down firmly on the rim to release the spray while inhaling deeply. For adults and children aged 6 years and older (with adult supervision), you can use 2 or 3 sprays in each nostril, but make sure not to do this more often than every 10 to 12 hours. Remember, you should not exceed 2 doses in a 24-hour period. If you’re considering this medication for a child aged 2 to under 6 years, it’s best to consult a doctor first. For children under 2 years, do not use this 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. 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

You should consult a doctor before using this medication 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.

In case of an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. If your symptoms continue or worsen, please stop using the medication and reach out to your healthcare provider for further guidance.

Warnings and Precautions

Before using this product, 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. Always follow the recommended dosage and do not use this product for more than three days. Overuse can lead to worsening nasal congestion. You may experience temporary discomfort, such as burning, stinging, sneezing, or increased nasal discharge.

If your symptoms persist, stop using the product and contact your doctor. Additionally, be cautious about sharing this product with others, as it may spread infection. While there are no specific emergency instructions provided, it's always best to seek immediate medical help if you feel unwell or have serious concerns.

Overdose

If you or someone else has swallowed too much of a medication, it's important to act quickly. You should seek medical help or contact a Poison Control Center immediately. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don't wait for symptoms to worsen; getting prompt assistance can be crucial. Always keep emergency contact numbers handy and be aware of the signs of overdose to ensure safety.

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

If you have a child aged 2 to under 6 years, it's important to consult with a doctor before using this medication. For children under 2 years old, you should not use this product at all.

For children aged 6 years and older, the recommended dosage is 2 or 3 sprays in each nostril, but this should not happen more frequently than every 10 to 12 hours, and it should always be done under adult supervision. Remember, do not exceed 2 doses in a 24-hour period. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

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 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 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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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 25°C (77°F). Keeping it within this temperature range helps maintain its quality and performance.

When handling the product, always do so with care to avoid any damage. Make sure to follow any specific instructions provided for use, and if you have any questions about disposal or further handling, consult the guidelines or your healthcare provider for assistance.

Additional Information

You should use this medication by spraying it into your nostrils. The recommended dosage is 2 or 3 sprays in each nostril, and you should wait at least 10 to 12 hours before taking another dose. It's important not to exceed 2 doses within a 24-hour period to ensure your safety and effectiveness of the treatment.

FAQ

What is VICKS Sinex™ SEVERE used for?

VICKS Sinex™ SEVERE is used to temporarily relieve nasal congestion due to a cold, hay fever, or other upper respiratory allergies, as well as sinus congestion and pressure.

How should I use VICKS Sinex™ SEVERE?

Remove the protective cap, prime the pump by pressing its rim several times, insert the nozzle into your nostril, and fully depress the rim while inhaling deeply.

What is the recommended dosage for adults and children over 6?

Adults and children 6 years and older 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 24 hours.

Are there any age restrictions for using this product?

Children under 2 years should not use VICKS Sinex™ SEVERE, and children aged 2 to under 6 years should ask a doctor before use.

What should I do if I experience side effects?

If you experience symptoms that persist, stop using the product and consult a doctor. Temporary discomfort such as burning or sneezing may occur.

Are there any warnings I should be aware of?

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.

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 should follow the recommended dosage to avoid worsening nasal congestion.

What should I do in case of overdose?

If swallowed, seek medical help or contact a Poison Control Center immediately.

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 specified 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

The protective cap should be removed prior to use. For first-time use, it is essential to prime the pump by firmly depressing its rim several times until a fine mist is produced. The container should be held with the thumb at the base and the nozzle positioned between the first and second fingers. The nozzle must be inserted into the nostril without tilting the head. A firm, even stroke should be applied to fully depress the rim while inhaling deeply.

For adults and children aged 6 years and older, the recommended dosage is 2 to 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. For children aged 2 to under 6 years, consultation with a physician is advised before use. The product is not recommended for children under 2 years of age.

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 these potential complications.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product to patients with certain pre-existing conditions. Prior to use, it is imperative to consult a physician if the patient has a history of heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

Patients should be advised to discontinue use and seek medical advice if symptoms persist. This precaution is essential to ensure that underlying conditions are not exacerbated.

It is critical to adhere to the recommended dosage guidelines. Patients should not exceed the advised dosage or use the product for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Additionally, temporary side effects such as burning, stinging, sneezing, or increased nasal discharge may occur during use.

Healthcare providers should also inform patients that sharing this product among multiple users may pose a risk of spreading infections.

Side Effects

Patients should be aware of several important warnings and potential adverse reactions associated with the use of this medication. It is advised that individuals 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 of overdosage, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Patients are also advised to discontinue use and consult a healthcare provider if symptoms persist. This precaution is essential to ensure the safety and well-being of individuals using the medication.

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 2 to under 6 years should consult a healthcare professional before use. The product is contraindicated in children under 2 years of age. For patients 6 years and older, the recommended dosage is 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours, and should not exceed 2 doses within a 24-hour period. Adult supervision is advised during administration.

Geriatric Use

There is no specific information 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 mothers.

Renal Impairment

There is no specific information available 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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nasal congestion, burning, stinging, sneezing, and increased nasal discharge. Additionally, it has been noted that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

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 during use. Additionally, it is important to inform patients that sharing this container with others may spread 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, 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 25°C to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

The medication is administered via the nasal route, with a recommended dosage of 2 or 3 sprays in each nostril, not to be taken more frequently than every 10 to 12 hours. Patients should not exceed 2 doses within a 24-hour period. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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.