Symptom checker
Select audience type

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

ADD CONDITION

items per page

Axiv Sinus Severe Ultra Fine Mist

Last content change checked dailysee data sync status

Active ingredient
Oxymetazoline Hydrochloride 0.5 mg/1 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Aerosol, 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
February 23, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride 0.5 mg/1 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Aerosol, 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
February 23, 2026
Manufacturer
VIVUNT PHARMA LLC
Registration number
M012
NDC root
82706-030
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

axiv® is a nasal decongestant designed to provide fast and powerful relief from severe nasal congestion. It contains oxymetazoline HCl (a medication that helps to shrink swollen blood vessels in the nasal passages), and is available in an ultra-fine mist for easy application. This product is effective for temporarily relieving nasal congestion caused by colds, hay fever, or other upper respiratory allergies, as well as sinus congestion and pressure.

With a maximum strength formula, axiv® offers up to 265 sprays in a 15 ml bottle, making it a convenient option for those seeking quick relief from uncomfortable nasal symptoms.

Uses

If you're dealing with a stuffy nose from a cold, hay fever, or other upper respiratory allergies, this medication can help. It works by temporarily relieving nasal congestion, making it easier for you to breathe. Additionally, if you're experiencing sinus congestion and pressure, this medication can provide relief from those uncomfortable symptoms as well.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so you can use it with confidence.

Dosage and Administration

When using this medication, adults and children aged 6 to under 12 years should spray 2 or 3 times into each nostril, but make sure not to do this more than every 10 to 12 hours. It's important to limit yourself to a maximum of 2 doses in a 24-hour period. If your child is under 6 years old, please consult a doctor before use.

To properly use the spray, start by removing the protective cap. If you’re using it for the first time, you’ll need to prime the pump by pressing down on the rim several times until you see a fine mist. Hold the container with your thumb at the base and your fingers on either side of the nozzle. Keep your head upright, insert the nozzle into your nostril, and then press down firmly on the rim while inhaling deeply. This will help ensure the medication is delivered effectively.

What to Avoid

You should avoid using this product if you have certain health conditions, including heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate, unless your doctor advises otherwise. It's important to follow the recommended dosage and not exceed it. Additionally, do not use this product for more than three days, as prolonged use can lead to worsening nasal congestion.

Always use this product as directed to minimize risks of misuse. Remember, taking more than the recommended amount or using it for an extended period can be harmful. If you have any concerns or questions about your health conditions and this product, please consult your healthcare provider.

Side Effects

Using this product may lead to some temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. It's important to follow the recommended dosage and not use it for more than three days, as frequent or prolonged use can worsen nasal congestion.

You should avoid using this product if you have certain health conditions, such as heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate, unless directed by a doctor. If your symptoms continue, please stop using the product and consult with a healthcare professional.

Warnings and Precautions

It's important to use this product safely to avoid potential issues. Make sure not to exceed the recommended dosage and do not use it for more than three days. Using it longer than directed can lead to worsening nasal congestion. If you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate, consult your doctor before using this product.

You may experience some temporary discomfort, such as burning, stinging, sneezing, or increased nasal discharge. Remember that sharing this product with others can spread infections. If your symptoms do not improve, stop using the product and reach out to your doctor for further advice.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and reach out for professional assistance if you have any concerns about an overdose. Your safety is the top priority, so don’t hesitate to get help.

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 under 6 years old, it's important to consult a doctor before using this medication. For children aged 6 to under 12 years, you can use the medication with adult supervision. 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. Remember, you should not give more than 2 doses in a 24-hour period to ensure your child's safety.

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 if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 monitor your kidney function and make any necessary adjustments to 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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account all the medications and tests you may be using. Always feel free to ask questions and share your complete health history to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its safety and effectiveness. Always follow any specific instructions provided with the product for optimal use.

Additional Information

No further information is available.

FAQ

What is axiv®?

axiv® is a maximum strength nasal decongestant that provides fast and powerful relief from severe sinus congestion.

What are the indications for using axiv®?

axiv® temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies, as well as sinus congestion and pressure.

How should I use axiv®?

To use axiv®, remove the protective cap, prime the pump, insert the nozzle into your nostril, and fully depress the rim while inhaling deeply. Do not exceed 2 or 3 sprays in each nostril every 10 to 12 hours.

Are there any contraindications for axiv®?

Do not use axiv® if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to prostate enlargement unless directed by a doctor.

What should I do if symptoms persist while using axiv®?

If symptoms persist, stop using axiv® and ask a doctor for advice.

Can I use axiv® if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using axiv®.

What are the potential side effects of axiv®?

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

How long can I use axiv®?

Do not use axiv® for more than 3 days, as frequent or prolonged use may worsen nasal congestion.

What should I do in case of an overdose?

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

Packaging Info

Below are the non-prescription pack sizes of Axiv Sinus Severe Ultra Fine Mist (oxymetazoline hydrochloride.). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Axiv Sinus Severe Ultra Fine Mist.
Details

Drug Information (PDF)

This file contains official product information for Axiv Sinus Severe Ultra Fine Mist, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Oxymetazoline HCl is presented in a concentration of 0.05%. The product is contained in a volume of 0.5 fluid ounces (15 mL).

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold. It also provides relief from nasal congestion due to hay fever and other upper respiratory allergies. Additionally, this drug alleviates sinus congestion and pressure.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 6 to under 12 years, under adult supervision, may receive 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. It is imperative not to exceed 2 doses within a 24-hour period. For children under 6 years of age, consultation with a physician is recommended prior to use.

To properly administer the medication, the following steps should be observed:

  1. Remove the protective cap from the spray nozzle.

  2. Prior to the initial use, prime the pump by firmly depressing its rim several times until a fine mist is produced.

  3. Hold the container with the thumb at the base and the nozzle positioned between the first and second fingers.

  4. Insert the nozzle into the nostril without tilting the head.

  5. Fully depress the rim with a firm, even stroke while inhaling deeply to ensure effective delivery of the medication.

Contraindications

Use of this product is contraindicated in patients with the following conditions:

  • Heart disease

  • High blood pressure

  • Thyroid disease

  • Diabetes

  • Difficulty in urination due to enlargement of the prostate gland, unless directed by a physician

Due to the potential for adverse effects, this product should not be used in these populations. Additionally, it is important to adhere to the recommended dosage and duration of use, as exceeding the recommended dosage or using the product for more than 3 days may lead to worsening nasal congestion or recurrence of symptoms.

Warnings and Precautions

The recommended dosage should not be exceeded, and this product is intended for use for no longer than three days. It is crucial to adhere strictly to the directions provided, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

This product is contraindicated in individuals with certain medical conditions. Specifically, it should not be used by patients with heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty in urination due to prostate gland enlargement, unless directed by a healthcare professional.

Users should be aware that temporary discomfort may occur, including sensations of burning, stinging, sneezing, or an increase in nasal discharge. Additionally, sharing this product among multiple users may facilitate the spread of infection.

Patients are advised to discontinue use and consult a physician if symptoms persist. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 for patients to adhere to the recommended dosage and to limit use to no more than three days, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patients with certain pre-existing conditions should avoid using this product unless directed by a healthcare professional. These conditions include heart disease, high blood pressure, thyroid disease, diabetes, and difficulty in urination due to enlargement of the prostate gland.

If symptoms persist despite use, patients are advised to discontinue use and consult a doctor 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 Axiv Sinus Severe Ultra Fine Mist (oxymetazoline hydrochloride.). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Axiv Sinus Severe Ultra Fine Mist.
Details

Pediatric Use

Pediatric patients under 6 years of age should consult a healthcare professional before use. For children aged 6 to under 12 years, 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. Adult supervision is advised during administration for this age group.

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 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

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 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 of this product.

Temporary discomfort may occur with the use of this product, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge.

No additional information is available regarding nonclinical toxicology or animal pharmacology and 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.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. It is important to emphasize that patients should not exceed the recommended dosage and should not use the product for more than three days. Patients should be instructed to use the product only as directed, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Providers should caution patients against using this product if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to prostate gland enlargement, unless directed by a healthcare professional.

Patients should be made aware that the product may cause temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is crucial to inform patients that sharing this container with others may lead to the spread of infection.

Finally, healthcare providers should instruct patients to stop using the product and consult a doctor if their symptoms persist.

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 room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Axiv Sinus Severe Ultra Fine Mist, 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 Axiv Sinus Severe Ultra Fine Mist, 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.