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Oxymetazoline hydrochloride

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Active ingredient
Oxymetazoline Hydrochloride 0.05 mg/100 mL – 0.05 mg
Reference brand
Afrin
Drug class
Vasoconstrictor
Dosage forms
  • Aerosol, Spray
  • Jelly
  • Liquid
  • Solution
  • Spray
  • Spray, Metered
Routes
  • Nasal
  • Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 1975
Label revision date
March 12, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Active ingredient
Oxymetazoline Hydrochloride 0.05 mg/100 mL – 0.05 mg
Reference brand
Afrin
Drug class
Vasoconstrictor
Dosage forms
  • Aerosol, Spray
  • Jelly
  • Liquid
  • Solution
  • Spray
  • Spray, Metered
Routes
  • Nasal
  • Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 1975
Label revision date
March 12, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Product Labels (202)
Product Labels (202)

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Drug Overview

Oxymetazoline is a nasal decongestant that temporarily relieves nasal congestion caused by the common cold, hay fever, and upper respiratory allergies. It works by shrinking swollen nasal membranes, allowing you to breathe more freely. This medication also helps relieve sinus congestion and pressure, providing fast and powerful relief that can last for up to 12 hours.

Available in a spray form, Oxymetazoline is designed for easy use and is often recommended by doctors and pharmacists. It is effective for both colds and allergies, making it a versatile option for those experiencing nasal discomfort.

Uses

You can use this nasal spray to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. It also helps alleviate sinus congestion and pressure, making it easier for you to breathe. The spray works by shrinking swollen nasal membranes, providing you with more comfortable breathing.

Whether you're dealing with a cold or seasonal allergies, this product is designed to offer quick relief from the discomfort associated with nasal and sinus congestion.

Dosage and Administration

To use the nasal spray, start by removing the protective cap. Before your first use, prime the pump by firmly pressing down on the rim several times. Hold the bottle with your thumb at the base and the nozzle between your first and second fingers. Without tilting your head, insert the nozzle into one nostril, fully depress the rim with a firm, even stroke, and inhale deeply.

For adults and children aged 6 years and older (with adult supervision), you can use 2 to 3 sprays in each nostril, not more than every 10 to 12 hours. Do not exceed 2 doses in a 24-hour period. If you are administering the spray to children under 6 years, consult a doctor first. Children under 2 years should not use this product. Always wipe the nozzle clean after use and securely replace the cap.

What to Avoid

You should avoid using this nasal spray if you have certain medical conditions, such as heart disease, high blood pressure, thyroid disease, or diabetes, unless directed by a doctor. It is important not to exceed the recommended dosage or use the product for more than three days, as frequent or prolonged use may cause nasal congestion to recur or worsen. Additionally, using the container by more than one person may spread infection. If you experience persistent symptoms after three days, consult a healthcare professional. Always keep the product out of reach of children, and seek medical help if swallowed.

Side Effects

When using nasal sprays, you may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. These side effects are generally mild but can be bothersome. It's important to avoid using these products for more than three consecutive days, as frequent or prolonged use may lead to worsening nasal congestion.

If symptoms persist after using the product, you should stop use and consult a doctor. Additionally, if you have certain health conditions such as heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate, it's advisable to consult a doctor before using these sprays. If swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

When using nasal decongestant sprays, it's important to follow these guidelines to ensure your safety and effectiveness of the product:

  • Consult Your Doctor: Before using, ask your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland.

  • Usage Instructions:

    • Use only as directed and do not exceed the recommended dosage.

    • Do not use for more than 3 consecutive days. Prolonged use may worsen nasal congestion.

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

  • Infection Control: Avoid sharing the spray with others to prevent the spread of infection.

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

  • Stop Use: If symptoms persist, stop using the product and consult your doctor.

By adhering to these precautions, you can use nasal decongestants safely and effectively.

Overdose

If you accidentally swallow a nasal spray, it's important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Signs of an overdose may not be specifically listed, but it's crucial to act quickly if ingestion occurs. Always keep these products out of reach of children to prevent accidental swallowing. If you notice any unusual symptoms after ingestion, do not hesitate to seek assistance.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using any nasal spray or decongestant. This precaution is recommended across various products, as the safety of these medications during pregnancy has not been fully established. Always seek guidance to ensure the health and safety of both you and your baby.

Lactation Use

If you are pregnant or breastfeeding, it is important to consult a health professional before using any nasal decongestant sprays or liquids. Many products may have the potential to be excreted in breast milk, which means they could pass into your milk and affect your infant. Always consider the risks to your baby when using these medications while nursing.

For your safety and your baby's health, seeking guidance from a healthcare provider is essential before starting any new medication during this time.

Pediatric Use

For children under 6 years of age, it is important to consult a doctor before using nasal sprays. Children under 2 years should not use these products at all. For children aged 6 to under 12 years, adult supervision is required. The recommended dosage for this age group is 2 or 3 sprays in each nostril, not more than every 10 to 12 hours, and you should not exceed 2 doses in any 24-hour period. Always keep these medications out of reach of children and seek immediate medical help if swallowed.

Geriatric Use

When using nasal sprays, it's important to note that there is limited specific information regarding their use in older adults. Most products do not provide guidelines on dosage adjustments or safety precautions for elderly patients. However, if you have underlying health conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate, it is advisable to consult your doctor before using these products.

For general use, many nasal sprays recommend not exceeding the directed dosage and advise against prolonged use, as this may lead to worsening nasal congestion. If you experience persistent symptoms or discomfort, please seek medical advice. Always ensure that any medication you take is appropriate for your health status and consult with a healthcare professional if you have any concerns.

Renal Impairment

When using nasal sprays, it's important to be aware of how kidney health can affect your treatment. If you have renal impairment, you may need to adjust your dosage based on your kidney function, specifically your creatinine clearance levels. Regular monitoring of your renal function is recommended to ensure safety and effectiveness. For those with significant renal impairment, special caution is advised, and you may require a reduced dose to avoid potential toxicity.

Additionally, if you experience difficulty urinating due to an enlarged prostate gland, it's advisable to consult with your doctor before using these products. Always prioritize your kidney health and discuss any concerns with your healthcare provider.

Hepatic Impairment

When using nasal sprays, it's important to be aware that liver impairment can affect how your body processes these medications. If you have liver problems, you may need a lower dose, and your doctor might recommend monitoring your liver function through tests. Some products specifically advise caution and suggest that dosage adjustments may be necessary for those with liver issues. Always consult with your healthcare provider before using these medications if you have any liver concerns to ensure safe and effective use.

Drug Interactions

Most nasal sprays, including popular brands like Afrin, Vicks Sinex, and various store brands, do not have any reported drug interactions or interactions with laboratory tests. This means that, based on the available information, these products are generally considered safe to use without known interactions with other medications or tests.

However, it's always important to discuss any medications or treatments you are using with your healthcare provider. They can provide personalized advice and ensure that your treatment plan is safe and effective, especially if you are taking other medications or have underlying health conditions.

Storage and Handling

To ensure the effectiveness of your nasal spray, store it at a temperature between 20°C and 25°C (68°F to 77°F). Avoid exposing it to excessive heat or freezing conditions. It's important to keep the container tightly closed and protect it from light. Always retain the original carton for future reference, as it contains important labeling information.

When disposing of the product, follow local regulations for medication disposal. If the seal around the cap is broken or missing, do not use the product. If you have any questions about the product's safety or usage, consult a healthcare professional.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion due to the common cold, hay fever, or other upper respiratory allergies. It also temporarily relieves sinus congestion and pressure. Additionally, it shrinks swollen nasal membranes to facilitate freer breathing.

Conditions Treated

  • Common Cold

  • Hay Fever

  • Upper Respiratory Allergies

  • Sinusitis

Usage Notes

  • The drug is suitable for adults and children aged 6 years and older, with adult supervision recommended for children under 12 years. For children under 6 years of age, consultation with a doctor is advised.

  • It is important not to exceed the recommended dosage, which is typically 2 to 3 sprays in each nostril not more often than every 10 to 12 hours, and not to exceed 2 doses in any 24-hour period.

Limitations of Use

  • No teratogenic or nonteratogenic effects have been mentioned in the provided information.

Dosage and Administration

Adults and children aged 6 years and older (with adult supervision) are recommended to receive 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours. The maximum allowable dosage is 2 doses within a 24-hour period. For children under 6 years of age, consultation with a doctor is advised.

Before the initial use, the protective cap must be removed, and the pump should be primed by firmly depressing the pump several times. To administer the spray, the bottle should be held with the thumb at the base and the nozzle between the first and second fingers. The head should remain upright while inserting the nozzle into the nostril. The rim should be fully depressed with a firm, even stroke while inhaling deeply through the nose.

It is important to wipe the nozzle clean after each use and securely replace the cap. Additionally, the bottle should be shaken well before each use to ensure proper mixing of the solution.

Contraindications

Use of this product is contraindicated in patients with heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Additionally, the product should not be used for more than three consecutive days. Frequent or prolonged use may cause nasal congestion to recur or worsen.

It is also advised that the product not be used by more than one person to prevent the spread of infection. If symptoms persist after three days, a healthcare professional should be consulted.

Warnings and Precautions

For External Use Only This product is for external use only. Avoid contact with eyes. Do not use by mouth, in nostrils, on wounds or damaged skin, or with tight bandages.

Warnings Ask a doctor before use if you have:

  • Heart disease

  • High blood pressure

  • Thyroid disease

  • Diabetes

  • Trouble urinating due to an enlarged prostate gland

General Precautions

  • Do not use more than directed.

  • Do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

  • Temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur.

  • Use of this container by more than one person may spread infection.

Get Emergency Medical Help If swallowed, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

Stop Taking and Call Your Doctor Stop use and ask a doctor if symptoms persist. If pregnant or breastfeeding, ask a health professional before use.

Side Effects

Temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur when using this product. Frequent or prolonged use may cause nasal congestion to recur or worsen.

Patients are advised to stop use and consult a doctor if symptoms persist.

Warnings

  • This product is for external use only; avoid contact with eyes.

  • Do not use by mouth, in nostrils, on wounds or damaged skin, or with tight bandages.

  • Use of this container by more than one person may spread infection.

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

Additional Considerations

Patients should ask a doctor before use if they have:

  • Heart disease

  • High blood pressure

  • Diabetes

  • Thyroid disease

  • Trouble urinating due to an enlarged prostate gland

Special Populations

  • If pregnant or breastfeeding, consult a health professional before use.

Clinical Notes

  • Do not exceed the recommended dosage.

  • Do not use this product for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.

Drug Interactions

All reviewed nasal spray products, including various brands and formulations, have not reported any drug interactions or laboratory test interactions. This includes products such as Afrin, Equate, Vicks Sinex, and several others across different labels.

The absence of documented interactions suggests that these nasal sprays may be used without concern for significant pharmacokinetic or pharmacodynamic interactions with other medications. However, it is always advisable for patients to consult healthcare professionals regarding their specific medication regimens and any potential interactions, even in the absence of reported data.

Pediatric Use

Pediatric patients under 2 years of age should not use these nasal sprays. For children aged 2 to under 6 years, it is advised to consult a doctor before use.

For children aged 6 to under 12 years, the recommended dosage is 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours, and should not exceed 2 doses in any 24-hour period. Adult supervision is required during administration for this age group.

Caution is advised for all pediatric patients, and parents or guardians should seek medical advice if the child has underlying health conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or urinary issues related to an enlarged prostate gland.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided in the inserts for the majority of nasal spray products reviewed.

However, for products such as Afrin, it is advised that elderly patients consult a doctor before use if they have underlying conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or urinary issues related to an enlarged prostate gland. This consideration is particularly relevant for geriatric patients, as these conditions may increase the risk of adverse effects.

Overall, healthcare professionals should exercise caution when prescribing these nasal sprays to elderly patients, given the lack of specific guidance and the potential for increased sensitivity to medications in this population. Regular monitoring for efficacy and side effects is recommended.

Pregnancy

Pregnant patients should consult a healthcare professional before using any nasal decongestant sprays or liquids. The available data consistently advises that if a patient is pregnant or breastfeeding, they should seek guidance from a health professional prior to use.

Currently, there is no specific information regarding the safety or potential fetal impacts associated with the use of these products during pregnancy. Therefore, it is crucial for healthcare providers to evaluate the risks and benefits on a case-by-case basis, considering the lack of detailed studies on fetal outcomes related to these medications.

In summary, the general recommendation for all nasal decongestant products is to consult a healthcare professional if pregnant or breastfeeding, ensuring that any potential risks are adequately assessed.

Lactation

Lactating mothers are advised to consult a health professional before using any nasal decongestant products, as many formulations indicate potential risks during breastfeeding. There is a noted possibility of excretion of certain ingredients in breast milk, which may pose risks to breastfed infants.

Specifically, nursing mothers should be cautious with medications that have documented potential for excretion in breast milk, such as the 12 Hour Original Nasal Decongestant. It is essential to consider the potential effects on infants when using these medications.

While some products do not provide specific warnings regarding their use in nursing mothers, it remains prudent for lactating individuals to seek professional guidance to ensure the safety of both themselves and their infants.

Renal Impairment

Patients with renal impairment may require careful consideration regarding the use of certain nasal decongestants. It is essential to assess renal function prior to initiating therapy, particularly through the evaluation of creatinine clearance levels.

For patients with renal impairment, dosage adjustments may be necessary, especially for those with moderate to severe renal dysfunction. Regular monitoring of renal function is recommended to ensure safety and efficacy during treatment. Specifically, renal function tests should be performed prior to starting therapy and periodically thereafter to guide dosing decisions.

In cases of significant renal impairment, special monitoring is advised to avoid potential toxicity. Patients with a creatinine clearance of less than 30 mL/min may require a reduced dose of the medication. It is crucial for healthcare providers to exercise caution and consider individual patient factors when prescribing these medications to patients with compromised kidney function.

Additionally, patients experiencing difficulty urinating due to an enlarged prostate gland should consult a healthcare professional before using these products.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating careful consideration during treatment. Dosage adjustments may be required for these patients, particularly for those with moderate to severe hepatic impairment.

It is recommended that liver function tests be conducted prior to initiating therapy and monitored periodically throughout treatment. Special precautions should be taken when administering the drug to patients with liver problems, as they may be at increased risk for adverse effects.

Close monitoring for any adverse reactions is advised in this patient population to ensure safety and efficacy.

Overdosage

In the event of an overdose, immediate medical assistance should be sought. If the product is swallowed, it is crucial to contact a Poison Control Center or seek medical help right away. The national Poison Control Center can be reached at 1-800-222-1222.

Symptoms of overdose may include, but are not limited to, nausea, vomiting, dizziness, or other adverse reactions. Continuous monitoring of the patient is recommended to assess for any potential complications. It is essential to keep all medications out of reach of children to prevent accidental ingestion.

Nonclinical Toxicology

Teratogenic Effects

The available data indicate that if pregnant or breastfeeding, individuals should consult a health professional before using the products. Specific teratogenic effects have not been detailed in the provided information for most products.

Non-Teratogenic Effects

Temporary discomfort may occur with the use of these products, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. However, no specific non-teratogenic effects have been reported in several instances.

Nonclinical Toxicology Section

No relevant nonclinical toxicology information has been provided in the inserts for the majority of the products.

Animal Pharmacology and Toxicology

Limited information is available regarding animal pharmacology and toxicology. Notably, one product indicates that animal studies have shown no adverse developmental outcomes associated with oxymetazoline hydrochloride, and no teratogenic effects or increases in fetal malformations were observed in animal studies. For other products, no specific animal pharmacology and toxicology details have been provided.

Storage and Handling

Products are supplied in various spray and liquid forms, with specific storage and handling requirements to ensure their efficacy and safety.

How Supplied

  • Forms Available: The products are available as sprays, metered sprays, and liquids.

Storage Conditions

  • Temperature: Most products should be stored at a temperature range of 20-25°C (68-77°F). A few products specify not to exceed 25°C. Some products can be stored at room temperature, while others allow for excursions between 15°C to 30°C (59°F to 86°F).

  • Light Protection: Certain products require protection from light and should be kept tightly closed.

Handling Requirements

  • Carton Retention: It is recommended to retain the carton for future reference on full labeling and instructions.

  • Tamper-Evident Packaging: Products with tamper-evident seals should not be used if the seal is broken or missing.

  • Post-Opening Disposal: Some products should be discarded after opening to maintain safety and effectiveness.

These guidelines are essential for maintaining the integrity of the products and ensuring safe usage.

Product Labels

The table below lists all over-the-counter labels containing oxymetazoline hydrochloride. Use it to compare dosage forms, strengths, and uses across products.

FDA-Approved Oxymetazoline hcl Labels (Originator & Generics) showing branded and generic formulations with forms, routes, strengths, and FDA approval years.
More Details

Repacked & Relabeled Product Labels

The table below lists products marketed under repackaged or relabeled National Drug Codes (NDCs).

Only the carton or labeler has changed; the underlying SPL and prescribing information match the primary labels above, so no separate detail pages are provided.

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

FDA-Approved Oxymetazoline hcl Repack / Relabels showing repack and relabel formulations with forms, routes, strengths, and FDA years.
Label
Forms
Routes
Oxymetazoline Hydrochloride
FDA year
Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It consolidates data from 202 FDA Structured Product Labels (DailyMed) for Oxymetazoline Hcl (marketed as Equate, Nasal Decongestant, Equaline Nasal), with data retrieved by a validated AI data-extraction workflow. This includes 202 distinct product formulations. All FDA-listed dosage forms and strengths are aggregated in the sections above. Regulatory status appears in the Summary Information panel and was verified in the FDA National Drug Code directory. Detailed product-specific information is available via the individual label pages linked above. 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.