Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Vicks Sinex Severe Congestion

Last content change checked dailysee data sync status

Active ingredient
Oxymetazoline Hydrochloride 0.0005 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 2026
Label revision date
December 18, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride 0.0005 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 2026
Label revision date
December 18, 2025
Manufacturer
Procter & Gamble Manufacturing GmbH
Registration number
M012
NDC root
64336-002
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 CONGESTION is a nasal spray that contains oxymetazoline HCl, a medication designed to help relieve nasal congestion. It works by temporarily easing congestion caused by colds, hay fever, or other upper respiratory allergies, as well as reducing sinus congestion and pressure. With its fast-acting formula, you can expect relief for up to 12 hours, making it a convenient option for managing your symptoms.

This nasal decongestant is available in a 15 ml (0.5 FL OZ) bottle, providing you with an easy-to-use solution for when you need quick relief from nasal and sinus discomfort.

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 also works to ease sinus congestion and pressure, making it easier for you to breathe comfortably.

You can rely on this treatment to help alleviate those bothersome symptoms, allowing you to feel more at ease during your recovery.

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 times in 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.

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, you should not use this medication at all. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this product safely to avoid potential issues. You should never exceed the recommended dosage, and it's advised not to use it for more than three days. Using it longer than directed can lead to a return or worsening of nasal congestion. Additionally, to prevent the spread of infection, avoid sharing this container with others.

By following these guidelines, you can help ensure that you use the product effectively and safely. If you have any questions or concerns about its use, 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. In case of an overdose, seek medical help or contact a Poison Control Center immediately.

You should stop using the medication and consult your doctor if your symptoms persist.

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 guidance. Always prioritize your health and seek professional advice when needed.

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 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, and do not exceed 2 doses in a 24-hour period.

For younger children, it's important to be cautious. If your child is between 2 and under 6 years old, you should consult a doctor before use. Additionally, this medication is not recommended for children under 2 years old, so please avoid using it for that age group. Always prioritize your child's safety and consult a healthcare professional if you have any questions.

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. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs, ensuring that any medication is safe and effective for you. Always keep an open line of communication with your doctor about any changes you notice while taking a new medication.

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, and there are no special monitoring or precautions outlined for patients like you.

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 provide guidance 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 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 receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature not exceeding 25ºC (77ºF). This helps maintain its quality and performance. When handling the product, be sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and compliance.

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 than once every 10 to 12 hours, and do not exceed 2 doses in a 24-hour period. If your child is between 2 and 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 CONGESTION?

VICKS Sinex™ SEVERE CONGESTION is an oxymetazoline HCl nasal decongestant available as a nasal spray.

What does VICKS Sinex™ SEVERE CONGESTION do?

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

How long does the relief last?

VICKS Sinex™ provides fast relief for up to 12 hours.

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 this product?

No, children under 2 years should not use VICKS Sinex™.

What should I do if symptoms persist?

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

Are there any warnings before using VICKS Sinex™?

Yes, 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 in case of overdose?

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

Is it safe to use VICKS Sinex™ during pregnancy or breastfeeding?

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

How should I store VICKS Sinex™?

Store VICKS Sinex™ at no greater than 25ºC.

Packaging Info

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

Packaging configurations for Vicks Sinex Severe Congestion.
Details

Drug Information (PDF)

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

For adults and children aged 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. 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.

  • Sharing this container among multiple individuals is contraindicated due to the risk of spreading infection.

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 of overdosage, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients are also instructed to discontinue use and seek medical advice if symptoms persist.

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 Congestion (oxymetazoline hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Vicks Sinex Severe Congestion.
Details

Pediatric Use

Pediatric patients aged 6 years and older may receive 2 or 3 sprays in each nostril, with administration not to exceed every 10 to 12 hours. It is important to note that the maximum dosage should not exceed 2 doses within a 24-hour period.

For children aged 2 to under 6 years, consultation with a healthcare professional is advised prior to use. The product is contraindicated in children under 2 years of age, and its use in this population is not recommended.

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 potential adverse effects or changes in efficacy, 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 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 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 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 is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

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

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 these contexts.

Postmarketing Experience

No postmarketing experience details are provided in the insert for Vicks Sinex Severe Congestion (oxymetazoline hydrochloride spray).

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.

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

Additionally, 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 storage conditions should be observed to ensure optimal performance and safety.

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, while the use of this medication is not recommended for children under 2 years.

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 Congestion, 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 Congestion, 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.

Learn more in our Editorial Policy

Last AI update:

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.