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Ultra Fine Mist

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Active ingredient
Oxymetazoline Hydrochloride 0.05 g/100 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 2020
Label revision date
August 22, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride 0.05 g/100 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 2020
Label revision date
August 22, 2025
Manufacturer
DOLGENCORP, INC.
Registration number
M012
NDC root
55910-627
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

Oxymetazoline HCl is a nasal decongestant that helps relieve nasal congestion caused by colds, heavy fevers, or upper respiratory allergies. It works by temporarily reducing swelling in the nasal passages, providing relief from sinus congestion and pressure for up to 12 hours. This medication is available in a convenient pump mist form, making it easy to use when you need quick relief from nasal discomfort.

Uses

If you're dealing with a cold, heavy fever, or upper respiratory allergies, this medication can help by temporarily relieving nasal congestion. It also works to ease sinus congestion and pressure, making it easier for you to breathe and feel more comfortable.

You can rely on this treatment to provide quick relief from these common symptoms, helping you get back to your daily activities with less discomfort.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. To prepare it for use, push down on the cap while turning it counter-clockwise to remove it. Don’t forget to take off the clip located under the rim. If you’re using the spray for the first time, you’ll need to prime the pump by pressing it down firmly several times until you see a fine mist.

For adults and children aged 6 years and older (with adult supervision), you can use 2 or 3 sprays in each nostril. Just remember not to 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, it’s best to consult a doctor before using this medication. For children under 2 years, do not use this product at all. After each use, wipe the nozzle clean, replace the clip under the rim, and securely put the cap back on.

What to Avoid

It's important to use this product safely and effectively. 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. 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 ensure your safety and well-being. If you have any concerns or questions about your use of this product, please consult a healthcare professional.

Side Effects

If you experience any persistent symptoms while using this medication, it's important to stop and consult your doctor. Additionally, you should talk to your healthcare provider before using this medication if you have any of the following conditions: heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland.

Being aware of these factors can help ensure your safety and the effectiveness of your treatment. Always prioritize open communication with your healthcare team regarding your health conditions.

Warnings and Precautions

If you accidentally swallow this medication, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your safety is a priority, so don’t hesitate to reach out for assistance.

You should stop using this medication and consult your doctor if your symptoms continue despite treatment. It’s essential to keep an open line of communication with your healthcare provider to ensure you receive the best care possible.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and 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

When using this medication for children, it's important to follow specific guidelines. For children aged 6 to under 12 years, you can administer 2 or 3 sprays in each nostril, but only 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, you should consult a doctor before use. For children who are 2 years old or younger, this medication should not be used at all.

Always keep this medication out of reach of children. If a child accidentally swallows it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 considering this medication, it’s important to consult with a healthcare provider. 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 your medication dosage may need to be adjusted. This is because renal impairment can affect how your body processes certain drugs. Your healthcare provider will monitor your kidney function regularly, especially by checking your creatinine clearance levels (a measure of how well your kidneys are filtering waste).

Before starting any new treatment, your renal function should be tested, and these tests will continue periodically to ensure your safety. If you have severe renal impairment, your doctor will take extra care in managing your treatment plan. Always communicate openly with your healthcare team about your kidney health to ensure the best outcomes.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. This means that your doctor might change how much of the drug you take to ensure it's safe and effective for you. Additionally, special monitoring of liver function tests (which check how well your liver is working) is recommended to keep an eye on your health.

Always exercise caution when taking this medication if you have liver dysfunction. Make sure to discuss your liver condition with your healthcare provider, as they will guide you on the best approach to manage your treatment safely.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, it is important to store it at room temperature. This helps maintain its effectiveness and integrity. When handling the product, always do so with clean hands and in a clean environment to avoid contamination.

If you have any specific components that come with the product, make sure to follow any additional instructions provided for their use or storage. Proper disposal of any used materials should also be done according to local regulations to ensure safety and environmental protection.

Additional Information

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.

FAQ

What is Oxymetazoline HCl used for?

Oxymetazoline HCl is a nasal decongestant that temporarily relieves nasal congestion due to a cold, heavy fever, or upper respiratory allergies.

How should I use Oxymetazoline HCl?

Shake well before use, prime the pump, and spray 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.

Are there any age restrictions for using this medication?

Adults and children 6 years and older can use it with adult supervision. For children 2 to under 6 years, consult a doctor, and it should not be used in children under 2 years.

What should I do if symptoms persist?

If symptoms persist, stop use and ask a doctor for further advice.

Are there any warnings associated with Oxymetazoline HCl?

Yes, if swallowed, seek medical help or contact a Poison Control Center immediately. Also, consult a doctor if you have heart disease, high blood pressure, diabetes, thyroid disease, or trouble urinating due to an enlarged prostate.

Can I use Oxymetazoline HCl if I am pregnant or breastfeeding?

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

How should I store Oxymetazoline HCl?

Store Oxymetazoline HCl at room temperature.

What are the potential side effects of using Oxymetazoline HCl?

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

Is there a risk of dependence or abuse with Oxymetazoline HCl?

There are no specified risks of dependence or abuse associated with Oxymetazoline HCl.

Packaging Info

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

Packaging configurations for Ultra Fine Mist.
Details

Drug Information (PDF)

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

View product document (PDF)

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with colds, heavy 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

Adults and children aged 6 years and older, with adult supervision, may receive 2 or 3 sprays in each nostril. Dosing should not occur more frequently than every 10 to 12 hours, and the total number of doses should not exceed 2 in any 24-hour period.

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

To administer the medication, the following steps should be followed:

  1. Shake the bottle well before use.

  2. Remove the cap by pushing down while turning it counter-clockwise.

  3. Remove the clip located under the rim of the bottle.

  4. Prior to the first use, prime the metered pump by firmly depressing it several times.

  5. To spray, hold the bottle with the thumb at the base and the nozzle positioned between the first and second fingers.

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

  7. Fully depress the rim with a firm, even stroke while sniffing deeply.

  8. After use, wipe the nozzle clean.

  9. Replace the clip under the rim and secure the cap after each use.

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.

Warnings and Precautions

In the event of accidental ingestion, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center at (1-800-222-1222) without delay.

Patients should discontinue use and consult a physician if symptoms persist. Continuous monitoring of the patient's condition is essential to ensure appropriate management and intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. In clinical practice, it is important to monitor for serious reactions, particularly in individuals with pre-existing conditions.

Patients are advised to stop use and consult a doctor if symptoms persist. Additionally, it is recommended that patients seek medical advice before using this medication if they have a history of heart disease, high blood pressure, diabetes, thyroid disease, or if they experience trouble urinating due to an enlarged prostate gland.

These precautions are essential to ensure the safe use of the medication and to mitigate any potential risks associated with its administration.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Ultra Fine Mist.
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, with a maximum of 2 doses in a 24-hour period. For children aged 2 to under 6 years, consultation with a healthcare provider is advised prior to use. The product is not recommended for children under 2 years of age.

It is essential to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at (1-800-222-1222).

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 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. 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 individuals.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that renal function is monitored regularly in these patients to ensure safe and effective treatment. Dosage adjustments should be based on creatinine clearance levels, with special consideration given to patients with severe renal impairment. Renal function tests should be performed prior to initiating therapy and periodically thereafter to assess the need for any modifications in dosing.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is recommended that liver function tests be monitored closely in this population to assess the impact of the drug on liver health. Caution should be exercised when administering the drug to patients with liver dysfunction, ensuring that any potential risks are carefully weighed against the benefits of treatment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, alterations in consciousness, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

Healthcare professionals should also consider contacting a poison control center for guidance on specific interventions and management strategies tailored to the substance involved in the overdose.

Nonclinical Toxicology

No teratogenic effects were observed in animal studies. Additionally, there was no increase in fetal malformations noted in these studies. Animal studies have demonstrated that oxymetazoline hydrochloride does not lead to adverse developmental outcomes.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no reported adverse events or case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at (1-800-222-1222) if the product is swallowed. Patients should be informed to discontinue use and consult a doctor if symptoms persist.

When using this product, it is essential to emphasize the importance of adhering to the recommended dosage and not exceeding it. Patients should be instructed not to use the product for more than three days and to follow the directions provided. They should be made aware that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patients may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. It is also important to inform patients that sharing this container with others may increase the risk of spreading infection.

Healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: heart disease, high blood pressure, diabetes, thyroid disease, 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 room temperature to maintain its integrity and effectiveness. Proper handling should be observed to ensure optimal quality throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 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 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.