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Nasal

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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 2014
Label revision date
November 2, 2024
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 2014
Label revision date
November 2, 2024
Manufacturer
H E B
Registration number
M012
NDC root
37808-004
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 maximum strength nasal spray that serves as a nasal decongestant. It contains 0.05% of the active ingredient oxymetazoline hydrochloride, which works quickly to provide powerful relief from nasal congestion caused by the common cold, hay fever, and upper respiratory allergies. This medication also helps to temporarily relieve sinus congestion and pressure by shrinking swollen nasal membranes, allowing you to breathe more freely.

Designed for convenience, this nasal spray offers relief that lasts for up to 12 hours, making it a helpful option for those dealing with congestion from colds and allergies.

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

When using this medication, adults and children aged 6 to under 12 years should spray 2 or 3 times in each nostril, but not more often than every 10 to 12 hours. It's important to remember that you should not exceed 2 doses in a 24-hour period. If your child is under 6 years old, please consult a doctor before use.

To apply the spray, start by pushing down firmly on the cap and turning it counterclockwise. When you're ready to spray, squeeze the bottle quickly and firmly, making sure not to tilt your head backward while doing so. After using the spray, wipe the nozzle clean and secure the cap to keep it safe for the next use.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should not use it for more than three days, and always follow the directions provided. Using it more than directed or for an extended period can lead to a worsening of nasal congestion, which is the very issue you may be trying to alleviate.

To protect your health, make sure to adhere strictly to these guidelines and avoid any misuse. If you have any questions or concerns about your treatment, don't hesitate to reach out to your healthcare provider for guidance.

Side Effects

If you experience any persistent symptoms while using this medication, it's important to stop use 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, 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 provider 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.

Before using this medication, you should consult your doctor 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. If your symptoms continue after using the medication, stop taking it and reach out to your doctor for further guidance.

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 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 using this medication. Always prioritize safety and follow these guidelines to ensure the well-being of your child.

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 your medication dosage may need to be adjusted. This adjustment is based on your creatinine clearance levels, which is a measure of how well your kidneys are filtering waste from your blood. Regular monitoring of your renal function is essential, so your healthcare provider will likely perform tests before starting treatment and periodically throughout your care.

For those with severe renal impairment, special attention is required to ensure your safety and the effectiveness of your treatment. Always communicate with your healthcare team about your kidney health, as they will guide you on the necessary steps to take.

Hepatic Impairment

If you have liver problems, it's important to know that your condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Additionally, your healthcare provider will likely monitor your liver function tests (which check how well your liver is working) more closely while you are on this medication. Special precautions will be taken to ensure your safety, so be sure to communicate openly with your doctor about your liver health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°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 guidelines will help you use the product safely and effectively.

Additional Information

You should use this medication through the nose (nasal administration). For adults and children aged 6 to under 12 years, the recommended dose is 2 or 3 sprays in each nostril, not more than every 10 to 12 hours, and do not exceed 2 doses in a 24-hour period. If your child is under 6 years old, consult a doctor for guidance.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. Be cautious, as sharing this container with others can lead to the spread of infection. In case of accidental swallowing, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Oxymetazoline HCl used for?

Oxymetazoline HCl is a nasal decongestant that temporarily relieves nasal congestion due to the common cold, hay fever, and upper respiratory allergies.

How should I use Oxymetazoline HCl nasal spray?

For adults and children aged 6 to under 12 years, use 2 or 3 sprays in each nostril every 10 to 12 hours, not exceeding 2 doses in 24 hours. Children under 6 years should consult a doctor.

Are there any side effects of using Oxymetazoline HCl?

Temporary discomfort such as burning, stinging, sneezing, or increased nasal discharge may occur. If symptoms persist, stop use and consult a doctor.

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

If you are pregnant or breastfeeding, ask a health professional before using Oxymetazoline HCl.

What should I do if I accidentally swallow Oxymetazoline HCl?

If swallowed, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

How should I store Oxymetazoline HCl?

Store Oxymetazoline HCl at 20-25°C (68-77°F) and retain the carton for future reference on full labeling.

Are there any contraindications for using Oxymetazoline HCl?

There are no explicit contraindications mentioned, but consult a doctor if you have heart disease, high blood pressure, diabetes, thyroid disease, or trouble urinating due to an enlarged prostate gland.

How long can I use Oxymetazoline HCl?

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

Packaging Info

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

Packaging configurations for Nasal.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Oxymetazoline hydrochloride 0.05% is a nasal decongestant formulated to provide fast and powerful relief from nasal congestion associated with colds and allergies. This product is designed for use in a 1 fluid ounce (30 mL) dosage form, offering sustained relief for up to 12 hours.

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 drug 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 physician is recommended prior to use.

To properly administer the medication, the user should push firmly down on the cap and turn it counterclockwise. While spraying, the bottle should be squeezed quickly and firmly, ensuring that the head is not tilted backward during the process. After use, the nozzle should be wiped clean, and the cap should be securely replaced.

Contraindications

Use is contraindicated in patients who exceed the directed dosage or utilize the product for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion.

Warnings and Precautions

If ingestion occurs, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Healthcare professionals are advised to instruct patients to discontinue use and consult a physician if symptoms persist.

Prior to initiating treatment, it is essential for patients to consult with a healthcare provider if they have any of the following medical conditions:

  • Heart disease

  • High blood pressure

  • Diabetes

  • Thyroid disease

  • Difficulty urinating due to an enlarged prostate gland

These precautions are critical to ensure the safe use of the medication and to mitigate potential adverse effects associated with underlying health issues.

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

Packaging configurations for Nasal.
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 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 use.

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 the safety of both the mother and the developing fetus.

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 may necessitate dosage adjustments based on their creatinine clearance levels. It is essential for healthcare professionals to monitor renal function regularly in these patients. Special consideration should be given to those with severe renal impairment, as they may require more careful management. Renal function tests should be performed prior to the initiation of treatment and periodically during the course of therapy to ensure appropriate dosing and to mitigate potential risks associated with reduced kidney function.

Hepatic Impairment

Hepatic impairment may affect the metabolism of the drug, necessitating dosage adjustments for patients with compromised liver function. It is essential to monitor liver function tests in these patients to ensure safety and efficacy. Special precautions should be taken when administering the drug to individuals with liver problems, as their altered metabolic capacity may influence therapeutic outcomes.

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 the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, the use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent. Consultation with a poison control center or toxicology expert is recommended for guidance on specific management strategies tailored to the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose situation effectively.

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.

Postmarketing Experience

Postmarketing experience has identified that temporary discomfort, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge, may occur following use. Additionally, it has been reported that the use of this container by more than one person may facilitate the spread of infection.

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 instruct patients not to exceed the recommended dosage and to limit use to no more than three days. Patients should be cautioned that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. They should also be made aware that temporary discomfort, such as burning, stinging, sneezing, or an increase in nasal discharge, may occur during use. Additionally, it is 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 prior to use 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 packaging that includes specific NDC numbers, which should be referenced for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals are advised to retain the carton for future reference regarding the full labeling information, ensuring that all necessary details are readily accessible for proper handling and administration.

Additional Clinical Information

The medication is administered via the nasal route. For adults and children aged 6 to under 12 years, the recommended dosage is 2 or 3 sprays in each nostril, not to be used more frequently than every 10 to 12 hours, with a maximum of 2 doses in a 24-hour period. For children under 6 years of age, consultation with a doctor is advised before use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to note that sharing this medication among multiple users may lead to the spread of infection. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Nasal, 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 Nasal, 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.