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Oxymetazoline hydrochloride

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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 2025
Label revision date
February 11, 2026
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 2025
Label revision date
February 11, 2026
Manufacturer
Prodose, Inc.
Registration number
M012
NDC root
68210-5056
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

This medication is designed to temporarily relieve nasal congestion caused by conditions such as the common cold, hay fever, and upper respiratory allergies. It works by shrinking swollen nasal membranes, which helps you breathe more freely. Additionally, it provides relief from sinus congestion and pressure, making it easier for you to feel comfortable when dealing with these common issues.

Uses

If you're dealing with nasal congestion from a common cold, hay fever, or upper respiratory allergies, this medication can help provide temporary relief. It works by shrinking swollen nasal membranes, making it easier for you to breathe. Additionally, it can alleviate sinus congestion and pressure, helping you feel more comfortable.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. If it's your first time using it, remove the protective cap from the tip and prime the metered pump by pressing it down firmly several times. When you're ready to spray, hold the bottle with your thumb at the base and your fingers around the nozzle. Keep your head upright, insert the nozzle into your nostril, and press down firmly on the rim while taking a deep sniff.

For adults and children aged 6 to under 12 years (with adult supervision), you can use 2 or 3 sprays in each nostril, but make sure not to do this more than every 10 to 12 hours. It's important not to exceed 2 doses in a 24-hour period. If your child is under 6 years old, please consult a doctor before use. After using the spray, remember to wipe the nozzle clean to keep it in good condition.

What to Avoid

It's important to use this medication responsibly to avoid potential risks. You should never use it for more than three days, and always follow the directions provided. Using it longer than recommended can lead to a worsening of nasal congestion. Additionally, be cautious not to exceed the directed dosage, as misuse can lead to complications.

To protect your health, avoid sharing this medication with others, as doing so may spread infection. Remember, using this product as intended is key to ensuring its effectiveness and your safety.

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 doctor before using this medication 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.

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

Warnings and Precautions

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

You should stop using this medication and consult your doctor if your symptoms do not improve. Always prioritize your health and safety by following these guidelines.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital right away. Having the medication packaging or details on hand can help healthcare professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

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 aged 6 to under 12 years, you can administer 2 or 3 sprays in each nostril, but only with adult supervision. It's important to space these doses at least 10 to 12 hours apart and not to exceed 2 doses in a 24-hour period.

For children under 6 years of age, you should consult a doctor before use. This ensures that the medication is safe and appropriate for your child's specific needs. Always prioritize your child's health and follow these guidelines carefully.

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 before starting the medication. 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. If your creatinine clearance (a measure of kidney function) is reduced, your healthcare provider will closely monitor your condition. Before starting treatment, and at regular intervals during your therapy, renal function tests will be performed to ensure your kidneys are handling the medication appropriately.

For those with moderate to severe renal impairment, a lower dose of the medication is recommended. Additionally, if you have end-stage renal disease, special care and consideration will be necessary to manage your treatment safely. Always communicate with your healthcare provider about your kidney health to ensure the best outcomes.

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, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This temperature range helps maintain the product's effectiveness and safety. It's also important to keep the original carton, as it contains valuable information about the product's labeling that you may need for future reference.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves nasal congestion due to the common cold, hay fever, and upper respiratory allergies, as well as sinus congestion and pressure.

How does this drug work?

It works by shrinking swollen nasal membranes, allowing you to breathe more freely.

What is the recommended dosage for adults and children aged 6 to under 12?

The recommended dosage is 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours, and do not exceed 2 doses in any 24-hour period.

What should I do if I have children under 6 years of age?

For children under 6 years of age, you should ask a doctor before use.

What are the administration instructions for this drug?

Shake well before use, remove the protective cap, and prime the pump. Insert the nozzle into the nostril and fully depress the rim while sniffing deeply.

Are there any warnings I should be aware of?

Yes, keep out of reach of children, and if swallowed, seek medical help immediately. Also, stop use and ask a doctor if symptoms persist.

Can I use this drug if I have certain health conditions?

You should 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.

What should I avoid while using this drug?

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

What should I do if I am pregnant or breastfeeding?

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

How should I store this drug?

Store between 20° to 25°C (68° to 77°F) and retain the carton for future reference on full labeling.

Packaging Info

Below are the non-prescription pack sizes of Oxymetazoline Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Oxymetazoline Hydrochloride.
Details

Drug Information (PDF)

This file contains official product information for Oxymetazoline Hydrochloride, 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 the common cold, hay fever, and upper respiratory allergies. It also provides temporary relief from sinus congestion and pressure. Additionally, this medication acts to shrink swollen nasal membranes, facilitating easier breathing.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 6 to under 12 years of age, when administered under adult supervision, may receive 2 or 3 sprays in each nostril. Dosing should not occur more frequently than every 10 to 12 hours, and it is important not to exceed 2 doses within a 24-hour period. For children under 6 years of age, consultation with a healthcare professional is advised prior to administration.

Prior to use, the bottle must be shaken well. For first-time use, the protective cap should be removed from the tip, and the metered pump must be primed by firmly depressing the pump several times. During administration, the bottle 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 should be fully depressed with a firm, even stroke while the patient sniffs deeply. After use, the nozzle should be wiped clean to maintain hygiene.

Contraindications

Use of this product is contraindicated in the following situations:

  • Patients should not exceed the recommended dosage or duration of use, specifically not to exceed 3 days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion.

  • The product should not be used by multiple individuals, as this may facilitate the spread of infection.

Warnings and Precautions

It is imperative to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should instruct patients to discontinue use and consult a physician if symptoms persist. This precaution is essential to ensure appropriate evaluation and management of the patient's condition.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. In the event that symptoms persist, it is advised to stop use and consult a healthcare professional.

Before initiating treatment, patients with certain pre-existing conditions should seek medical advice. Specifically, individuals with heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland are encouraged to consult a doctor prior to use.

These precautions are essential to ensure the safe and effective use of the medication, minimizing the risk of serious adverse reactions.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Oxymetazoline Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Oxymetazoline Hydrochloride.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. It is important to note that the total dosage should not exceed 2 doses within a 24-hour period. For children under 6 years of age, consultation with a healthcare professional is advised prior to use.

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. It is advisable to monitor these patients closely for any 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 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 receiving treatment. It is essential that patients with reduced creatinine clearance are closely monitored throughout their therapy. Prior to initiation of treatment, renal function tests should be performed, and these tests should be conducted periodically during the course of treatment to ensure ongoing safety and efficacy. For patients with moderate to severe renal impairment, a reduced dose is recommended to mitigate potential risks. Additionally, special consideration should be given to patients with end-stage renal disease, as their management may require further adjustments and monitoring.

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 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 considered as part of standard clinical practice.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential risks associated with excessive administration of the medication.

Should an overdosage occur, it is recommended that healthcare providers assess the patient for any signs or symptoms that may arise. Common symptoms of overdosage may include, but are not limited to, severe adverse reactions or exacerbation of known side effects.

Management of an overdosage situation should involve immediate supportive care tailored to the patient's clinical presentation. Healthcare professionals are advised to monitor vital signs closely and provide symptomatic treatment as necessary. In cases where the overdosage is significant, consultation with a poison control center or toxicology expert may be warranted to determine the most appropriate course of action.

It is crucial to document the incident thoroughly and report any overdosage cases to the relevant regulatory authorities to enhance the understanding of the medication's safety profile.

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 an increase in nasal discharge. No relevant information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no pertinent data provided from animal pharmacology and toxicology studies.

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed 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 directed dosage and should not use it for more than three days. 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 important to inform patients that using this container by more than one person may increase the risk of spreading infection.

Additionally, 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, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be retained for future reference regarding full labeling information. It is essential to store the product at a controlled temperature between 20° to 25°C (68° to 77°F). Additionally, the carton should be kept for future reference to ensure compliance with labeling requirements.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Oxymetazoline Hydrochloride, 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 Oxymetazoline Hydrochloride, 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

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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.