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Nasal Decongestant

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Active ingredient
Oxymetazoline Hydrochloride 0.05 g/100 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Spray, Metered
Route
Nasal
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
September 10, 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, Metered
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 2018
Label revision date
September 10, 2024
Manufacturer
Major Pharmaceuticals
Registration number
M012
NDC root
0904-6761
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 hydrochloride is a nasal decongestant available as a soothing spray that provides relief for up to 12 hours. It is designed to temporarily relieve nasal congestion caused by common colds, hay fever, and upper respiratory allergies. Additionally, it helps alleviate sinus congestion and pressure by shrinking swollen nasal membranes, allowing you to breathe more freely.

This medication comes in a 0.05% concentration and is packaged in a 1 fluid ounce (30 mL) bottle. It is comparable to the active ingredient found in Afrin® No Drip, making it a reliable option for those seeking relief from nasal discomfort.

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, if you're experiencing sinus congestion and pressure, this medication can also help alleviate those symptoms. With its ability to clear up nasal passages, you can feel more comfortable and breathe more freely.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. To prepare it for use, hold the white tabs, squeeze the grooved area of the cap firmly, and turn it counterclockwise. If you’re using it for the first time, you’ll need to prime the metered pump by pressing it down several times until you see a spray.

For adults and children aged 6 to under 12 years, you can use 2 or 3 sprays in each nostril, but make sure not to do this more often than every 10 to 12 hours. It’s important not to exceed 2 doses in a 24-hour period. If the user is a child under 6 years old, please consult a doctor before use. When spraying, hold the bottle with your thumb at the base and your fingers on either side of the nozzle. Insert the nozzle into the nostril without tilting your head, then press down firmly and sniff deeply. After using, wipe the nozzle clean and secure the cap.

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 or cause it to return after stopping the medication.

To avoid potential issues, make sure to adhere strictly to the recommended dosage. This will help you achieve the best results while minimizing any risks associated with misuse.

Side Effects

You may not experience any specific side effects from this medication. However, if your symptoms persist, it’s important to stop using the product and consult your doctor.

Before using this medication, you should talk to your doctor 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.

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 also stop using the medication and consult your doctor if your symptoms continue. It’s essential to keep an open line of communication with your healthcare provider to ensure your well-being.

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, or if you are unsure, 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 use. This ensures that the medication is safe and appropriate for your child's specific needs. Always prioritize your child's health and safety by following these guidelines.

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 is because your kidneys may not process the medication as effectively. Regular monitoring of your kidney function is essential, and this typically involves tests to measure your creatinine clearance (a test that estimates how well your kidneys are filtering waste).

Before starting any new treatment, your renal function should be assessed, and it’s crucial to continue checking it periodically throughout your therapy. If you have severe kidney impairment, special care will be taken to ensure your treatment is safe and effective. Always discuss any concerns with your healthcare provider to ensure you receive the best care tailored to your needs.

Hepatic Impairment

If you have liver problems, it's important to know that your condition can affect how your body processes certain medications. Because of this, you should be closely monitored for any side effects while on treatment. Before starting therapy, your doctor will likely perform liver function tests (which check how well your liver is working) and may continue to do so periodically during your treatment.

Depending on the severity of your liver impairment, your doctor may need to adjust your medication dosage. If you have moderate to severe liver issues, a lower dose might be necessary to ensure your safety and the effectiveness of the treatment. Always communicate openly with your healthcare provider about your liver health to ensure the best care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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 nasal route. For adults and children aged 6 to under 12 years (with adult supervision), 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 the patient is under 6 years old, consult a doctor for guidance on use.

FAQ

What is Oxymetazoline hydrochloride?

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

How does Oxymetazoline work?

It works by shrinking swollen nasal membranes, allowing you to breathe more freely and relieving sinus congestion and pressure.

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, with a maximum of 2 doses in any 24-hour period.

Can children under 6 use Oxymetazoline?

Children under 6 years of age should ask a doctor before use.

What should I do if symptoms persist?

You should stop using Oxymetazoline and ask a doctor if your symptoms persist.

Are there any warnings for using Oxymetazoline?

Yes, 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 swallow Oxymetazoline?

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

Is it safe to use Oxymetazoline during pregnancy or breastfeeding?

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

What storage conditions are recommended for Oxymetazoline?

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

Packaging Info

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

Packaging configurations for Nasal Decongestant.
Details

Drug Information (PDF)

This file contains official product information for Nasal Decongestant, 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 as a spray. Each unit contains 1 fluid ounce (30 mL) of the solution. This product is designed to provide soothing relief for up to 12 hours. It is the original formulation and is comparable to the active ingredient found in Afrin® No Drip.

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.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

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 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.

Prior to administration, the product must be shaken well. To prepare the device for use, hold the white tabs, squeeze the grooved area of the cap firmly, and turn it counterclockwise. Before the initial use, the metered pump should be primed by firmly depressing the pump several times.

For application, 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 user sniffs deeply. After use, the nozzle must be wiped clean, and the cap should be secured.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the following usage guidelines to prevent potential complications:

  • Do not exceed the recommended dosage.

  • Do not use for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion.

Healthcare professionals should ensure that patients are informed of these instructions to mitigate risks associated with misuse.

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 for guidance.

Should symptoms persist despite use, it is imperative to discontinue the product and consult a physician for further evaluation and management.

Side Effects

Patients should be aware that there are no specific side effects listed for this medication. However, it is important to monitor for any symptoms that may persist, as individuals are advised to stop use and consult a doctor if such symptoms occur.

Before using this medication, patients with certain pre-existing conditions should seek medical advice. These conditions include heart disease, high blood pressure, thyroid disease, diabetes, and trouble urinating due to an enlarged prostate gland.

There are no additional adverse reactions reported in clinical trials or postmarketing experiences.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Nasal Decongestant.
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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 drug 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 require dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to monitor renal function regularly in these patients. Adjustments in dosage should be guided by creatinine clearance levels, with particular attention given to those with severe renal impairment. Prior to initiating therapy, renal function tests should be conducted, and ongoing assessments should be performed periodically throughout the treatment course.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating careful consideration during treatment. It is essential that these patients are monitored closely for any adverse effects that may arise as a result of their compromised liver function.

Prior to initiating therapy, liver function tests should be conducted to establish a baseline. Additionally, these tests should be performed periodically throughout the course of treatment to ensure ongoing assessment of liver health.

For patients classified with moderate to severe hepatic impairment, dosage adjustments may be required to mitigate the risk of potential adverse effects. A reduced dose should be considered in these cases to ensure safety and efficacy in this patient population.

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.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Continuous assessment and supportive care are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, ensuring that appropriate interventions are undertaken promptly.

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 specific information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has indicated that the use of this product may be associated with temporary discomfort, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. These events have been reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

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.

Additionally, healthcare providers should caution patients that the use of this container by more than one person may increase the risk of spreading infection. It is also important to ask patients about their medical history and advise them to consult a doctor before use 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 referenced as needed. 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 relevant 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, it is recommended to use 2 or 3 sprays in each nostril, not more frequently than every 10 to 12 hours, with a maximum of 2 doses within a 24-hour period. For children under 6 years of age, consultation with a doctor is advised prior to use.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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