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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 2015
Label revision date
December 3, 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 2015
Label revision date
December 3, 2025
Manufacturer
Procter & Gamble Manufacturing GmbH,
Registration number
M012
NDC root
64336-171
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. 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 can last for up to 12 hours.

This product also features powerful Vicks vapors, enhancing your comfort during times of congestion. It is available in a convenient ½ FL OZ (15 ml) bottle, making it easy to use when you need it most.

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 symptoms, giving you a sense of comfort and relief. Remember, it's designed for short-term use to help you feel better when you're under the weather.

Dosage and Administration

To use this nasal spray, start by removing the protective cap. If it's 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. When you're ready to apply the spray, hold the container with your thumb at the base and your fingers around the nozzle. Keep your head upright, insert the nozzle into one nostril, and press down firmly on the rim 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. Make sure to wait at least 10 to 12 hours before using it again, and do not exceed 2 doses in a 24-hour period. If you're considering this spray for children aged 2 to under 6 years, it's best to consult a doctor first. Please avoid using it for children under 2 years old.

What to Avoid

It's important to use this product safely to ensure your 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 usage, please consult a healthcare professional.

Side Effects

When using this product, you may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. These side effects are generally mild and should resolve on their own.

However, if your symptoms persist, it’s important to stop using the product and consult a doctor 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, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Always follow the recommended dosage and do not use the product for more than three days. Overuse can lead to worsening nasal congestion, and you may experience temporary discomfort like burning, stinging, sneezing, or increased nasal discharge. Additionally, sharing this product with others can spread infections.

If you accidentally swallow the product, seek emergency 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 get checked by a medical professional.

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 make sure to space these doses at least 10 to 12 hours apart. It's crucial not to exceed 2 doses within a 24-hour period, and always supervise your child while they are using the medication.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it's important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication about any changes in health or medication effects.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 share your complete list of medications and any health conditions you have to receive the best care possible.

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, make sure to follow any specific instructions provided to avoid contamination or damage. Always ensure that you are in a clean environment to maintain a sterile field (a clean area free from germs) if applicable. Proper storage and careful handling are key to ensuring the product works as intended.

Additional Information

You will use this medication through your nose (nasal administration). The recommended dosage is 2 or 3 sprays in each nostril, and you should not use it more than once every 12 hours. Make sure to limit yourself to a maximum of 2 doses within a 24-hour period to ensure safe use.

FAQ

What is VICKS Sinex™ SEVERE?

VICKS Sinex™ SEVERE is an oxymetazoline HCl nasal decongestant that temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies.

How does VICKS Sinex™ SEVERE work?

It works by temporarily relieving nasal congestion and sinus pressure.

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

You should use 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.

Can children under 2 years use VICKS Sinex™ SEVERE?

No, children under 2 years should not use this product.

What should I do if symptoms persist?

You should stop using the product and ask a doctor if symptoms persist.

Are there any side effects associated with VICKS Sinex™ SEVERE?

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

How long can I use VICKS Sinex™ SEVERE?

You should not use this product for more than 3 days, as frequent or prolonged use may cause nasal congestion to recur or worsen.

What should I do if I accidentally swallow VICKS Sinex™ SEVERE?

If swallowed, get medical help or contact a Poison Control Center right away.

Is there any specific advice for pregnant or breastfeeding women?

If you are pregnant or breastfeeding, you should ask a health professional before use.

What precautions should I take before using VICKS Sinex™ SEVERE?

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

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.

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

Before administration, the protective cap must be removed. For first-time use, the pump should be primed by firmly depressing its rim several times. The container should be held with the thumb at the base and the nozzle positioned between the first and second fingers. The nozzle should be inserted into the nostril without tilting the head. The rim must be fully depressed with a firm, even stroke while inhaling deeply.

For adults and children aged 6 years and older (with adult supervision), the recommended dosage is 2 or 3 sprays in each nostril, not to be administered more frequently than every 10 to 12 hours. The maximum allowable dosage is 2 doses within a 24-hour period.

For children aged 2 to under 6 years, consultation with a physician is advised prior to use. The product is not recommended for children under 2 years of age.

Administration is via the intranasal route, utilizing the nasal spray method as described.

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 directions provided.

Warnings and Precautions

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

When utilizing this product, it is imperative to adhere strictly to the recommended dosage. The product should not be used for more than three consecutive days, and it should only be used as directed. Exceeding the recommended dosage or prolonged use may lead to a recurrence or worsening of nasal congestion. Users may experience temporary discomfort, which can include burning, stinging, sneezing, or increased nasal discharge. Additionally, sharing this product among multiple users may facilitate the spread of infection.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Patients are advised to discontinue use and consult a healthcare professional if symptoms persist.

Side Effects

Patients using this product may experience temporary discomfort, which can include sensations of burning, stinging, sneezing, or an increase in nasal discharge. These reactions are generally mild and transient.

If symptoms persist, patients are advised to discontinue use and consult a healthcare professional for further evaluation and guidance.

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, with a maximum of 2 doses within a 24-hour period. Administration should occur under adult supervision to ensure safety.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended 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 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.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

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

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Temporary discomfort may occur, including symptoms such as burning, stinging, sneezing, or increased nasal discharge. No additional information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of several adverse reactions associated with the use of this product. These include nasal congestion, burning, stinging, sneezing, and increased nasal discharge. Additionally, there have been reports of infections linked to the use of this product.

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, high blood pressure, thyroid disease, diabetes, or difficulty 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 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, with a recommended dosage of 2 or 3 sprays in each nostril, not to be taken more frequently than every 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 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.