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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 2006
Label revision date
March 13, 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 2006
Label revision date
March 13, 2025
Manufacturer
Taro Pharmaceuticals U. S. A. , Inc.
Registration number
M012
NDC root
51672-2030
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 that comes in a convenient 12-hour spray form. It is designed to provide temporary relief from nasal congestion caused by the common cold, hay fever, upper respiratory allergies, and sinusitis. By reducing the swelling of the nasal passages, it helps you breathe more freely through your nose, offering fast-acting relief that can last up to 12 hours.

This medication contains an active ingredient that is frequently recommended by physicians and pharmacists, making it a trusted choice for those seeking relief from nasal congestion. It is similar to the active ingredient found in Afrin®, and is available in a 1 fl oz (30 mL) bottle for easy use.

Uses

If you're dealing with nasal congestion from a common cold, hay fever, or other upper respiratory allergies, this medication can provide temporary relief. It works by reducing the swelling in your nasal passages, helping you breathe more freely through your nose. Additionally, if you're experiencing congestion related to sinusitis, this treatment can also help alleviate those symptoms.

Overall, this medication is designed to make it easier for you to breathe when you're feeling congested due to various conditions affecting your nasal passages.

Dosage and Administration

When using this medication, adults and children aged 6 to under 12 years should spray 2 to 3 times in each nostril. You can do this every 10 to 12 hours, but make sure not to exceed 2 doses in a 24-hour period. If your child is under 6 years old, it’s important to consult a doctor before using this medication.

To properly use the spray, hold the bottle upright and squeeze it quickly and firmly. Avoid tilting your head backward while spraying to ensure the medication works effectively. After each use, remember to wipe the nozzle clean to keep it free from any residue.

What to Avoid

It's important to use this medication responsibly. You should not take it for more than three days. This guideline helps prevent potential issues and ensures that you are using the medication safely. Always follow this instruction to avoid any complications. If you have any questions or concerns about your treatment, please consult your healthcare provider for guidance.

Side Effects

Using this product may lead to some temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. It's important to note that sharing this container with others can spread infections.

If you use the product frequently or for an extended period, you might find that nasal congestion returns or worsens. If your symptoms continue, please stop using the product and consult a doctor for further advice.

Warnings and Precautions

It's important to follow the recommended dosage when using this product, as exceeding it can lead to complications. You may experience temporary discomfort, such as burning, stinging, sneezing, or increased nasal discharge. Additionally, sharing this product with others can spread infections, so it's best to use it alone. Please do not use this product for more than three days in a row.

Before using this product, consult 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. Be aware that frequent or prolonged use may cause your nasal congestion to return or worsen. If your symptoms persist, stop using the product and contact your doctor. Always keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

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

Signs of an overdose can vary, but they may include unusual symptoms that require prompt attention. Always err on the side of caution and reach out for help if you are unsure about the situation. Your safety is the top priority.

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 to 3 sprays in each nostril, but only every 10 to 12 hours. It's important not to exceed 2 doses in a 24-hour period. For children under 6 years old, you should consult a doctor before use to ensure safety and proper guidance. Always follow these recommendations to help keep your child safe and healthy.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory) that can occur with age.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for determining the appropriate use of this medication based on individual health needs. Always ensure that any treatment plan is tailored to your specific situation.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication, especially if you experience difficulty urinating due to an enlarged prostate gland. Your healthcare provider can help determine if this medication is safe for you and may suggest adjustments to your dosage or monitoring based on your kidney function. Always prioritize open communication with your doctor regarding any concerns related to your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective 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 share your complete list of medications and any lab tests you undergo, as this can help prevent any potential issues and support your overall health.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C to 25°C (68°F to 77°F). It's important to keep the bottle upright and protect it from light to maintain its effectiveness. Once you open the bottle, please remember to discard it after use to ensure safety and prevent contamination. Following these guidelines will help you handle 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 supervision), the recommended dose is 2 to 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 on the appropriate use.

FAQ

What is Oxymetazoline Hydrochloride used for?

Oxymetazoline Hydrochloride is a nasal decongestant used for temporary relief of nasal congestion due to the common cold, hay fever, or sinusitis.

How does Oxymetazoline Hydrochloride work?

It reduces swelling of nasal passages and temporarily restores freer breathing through the nose.

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

The recommended dosage is 2 to 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 years use Oxymetazoline Hydrochloride?

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

What should I do if symptoms persist?

You should stop using the product and ask a doctor if symptoms persist.

Are there any warnings associated with this product?

Yes, it may cause temporary discomfort such as burning or sneezing, and frequent or prolonged use may worsen nasal congestion.

How should I store Oxymetazoline Hydrochloride?

Store it at 20°C to 25°C (68°F to 77°F), protect it from light, and keep the bottle upright.

Is it safe to use Oxymetazoline Hydrochloride during pregnancy or breastfeeding?

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

What should I do if I accidentally swallow Oxymetazoline Hydrochloride?

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

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

This nasal decongestant is formulated as a 12-hour spray containing 0.05% oxymetazoline hydrochloride, recognized for its maximum strength and fast-acting properties. It provides relief for up to 12 hours and is the active ingredient most frequently recommended by physicians and pharmacists. The product is available in a 1 fluid ounce (30 mL) container.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies, as well as congestion related to sinusitis. It effectively reduces swelling of the nasal passages, thereby temporarily restoring freer breathing through the nose.

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 may receive 2 to 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.

For administration, the healthcare professional should instruct the patient to squeeze the bottle quickly and firmly while keeping the head upright. It is essential to avoid tilting the head backward during the spraying process. After use, the nozzle should be wiped clean to maintain hygiene and prevent blockage.

Contraindications

Use of this product is contraindicated for durations exceeding three days. Prolonged use may lead to potential adverse effects not specified in the provided data.

Warnings and Precautions

The recommended dosage should not be exceeded to avoid potential adverse effects. Users may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. It is important to note that sharing this product among multiple users may facilitate the spread of infection.

This product is not intended for use beyond a duration of three days. Prior to use, individuals should consult a healthcare professional if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to prostate gland enlargement.

Users should be aware that frequent or prolonged use of this product may lead to a recurrence or worsening of nasal congestion. If symptoms persist, it is advised to discontinue use and seek medical advice.

To ensure safety, this product should be kept 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 recommended.

Side Effects

Patients using this product may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. It is important to note that the use of this container by more than one person may lead to the spread of infection.

Frequent or prolonged use of the product has been associated with the recurrence or worsening of nasal congestion. Therefore, patients are advised to monitor their symptoms closely.

If symptoms persist, patients should discontinue use and consult a healthcare professional for further evaluation and guidance.

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 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 use the medication with adult supervision, receiving 2 to 3 sprays in each nostril, not to exceed 2 doses within a 24-hour period. For children under 6 years of age, it is advised to consult a doctor before 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: burning, stinging, sneezing, and an increase in nasal discharge.

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.

Patients should be informed not to use the product for more than three days. They should be advised to stop use and consult a doctor if their symptoms persist. It is important to communicate that frequent or prolonged use of the product may lead to a recurrence or worsening of nasal congestion.

Additionally, healthcare providers should encourage patients to consult with 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 a container that must be stored at a temperature range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to maintain its integrity. The bottle should be kept in an upright position during storage. Additionally, it is important to discard the product after opening to ensure safety and efficacy.

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 to 3 sprays in each nostril, not to be taken 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, it is advised to consult a doctor regarding appropriate 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 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.