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Afrin Original 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 2020
Label revision date
November 5, 2023
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 2020
Label revision date
November 5, 2023
Manufacturer
JC World Bell Wholesale Co. , Inc.
Registration number
M012
NDC root
50269-017
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

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

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. You can do this no more than 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 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, but remember 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 next time.

What to Avoid

It's important to use this medication responsibly to avoid potential issues. You should not use it for more than three days, as prolonged use can lead to worsening nasal congestion. Additionally, make sure to follow the dosage instructions carefully and do not exceed the recommended amount. This will help you avoid any risks associated with misuse or overuse.

Side Effects

When using this product, you may experience temporary discomfort, which can include sensations like burning, stinging, sneezing, or an increase in nasal discharge. These side effects are generally mild and should resolve on their own.

However, if your symptoms persist, it’s important to stop using the product and consult a doctor for further guidance.

Warnings and Precautions

Before using this medication, it’s important to 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. Always follow the directions carefully—do not exceed the recommended dosage or use it for more than three days, as doing so may lead to worsening nasal congestion. You might experience temporary discomfort, such as burning, stinging, sneezing, or increased nasal discharge. Additionally, sharing this medication with others can spread infections.

If your symptoms do not improve, stop using the medication and reach out to your doctor for further advice. In case of accidental ingestion, seek medical help immediately or contact a Poison Control Center.

Overdose

If you or someone else has swallowed too much of a medication, it's important to act quickly. You should seek medical help or contact a Poison Control Center immediately. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don't wait for symptoms to appear; getting help right away can make a significant difference. Always keep emergency contact numbers handy and be aware of the steps to take in case of an overdose. 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

If you have a child under 6 years old, it's important to consult with a doctor before using this medication. For children aged 6 to under 12 years, you can use it with adult supervision. The recommended dosage is 2 or 3 sprays in each nostril, but make sure to space these doses at least 10 to 12 hours apart. Additionally, do not give more than 2 doses in a 24-hour period to ensure your child's safety. Always follow these guidelines to help keep your child 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 wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

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 should be used if you have hepatic impairment (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 any necessary adjustments to your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). It's important to keep the original carton, as it contains valuable information about the product that you may need later.

After each use, make sure to wipe the nozzle clean to prevent contamination and secure the cap tightly to maintain the product's integrity. Following these simple steps will help you use the product safely and effectively.

Additional Information

You should use this medication as a nasal spray. 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 your child is under 6 years old, consult a doctor before use.

Before using this medication, it's important to ask a 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. If you are pregnant or breastfeeding, consult a health professional first. Always keep this medication out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What conditions does this drug temporarily relieve?

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

How does this drug work?

It shrinks swollen nasal membranes, allowing you to breathe more freely.

What are the instructions for using this drug?

For adults and children 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 should ask a doctor.

What should I do if symptoms persist?

Stop use and ask a doctor if symptoms persist.

Are there any side effects?

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

What precautions should I take before using this drug?

Ask a doctor before use if you have heart disease, high blood pressure, diabetes, thyroid disease, or trouble urinating due to an enlarged prostate gland.

Can I use this drug if I am pregnant or breastfeeding?

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

How should I store this drug?

Store between 20° to 25°C (68° to 77°F) and keep out of reach of children.

What should I do if I accidentally swallow this drug?

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

Is there a risk of dependence or abuse with this drug?

There are no specific concerns about dependence, but frequent or prolonged use may cause nasal congestion to recur or worsen.

Packaging Info

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

Packaging configurations for Afrin Original Nasal.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

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.

For proper administration, the following steps should be followed: Firmly push down on the cap and turn it counterclockwise to open. To deliver the spray, squeeze the bottle quickly and firmly while ensuring that the head is not tilted backward during the application. 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 use the product for more than three consecutive days. Prolonged use may lead to a recurrence or worsening of nasal congestion.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product, particularly in patients with specific underlying health conditions. It is imperative to consult a physician prior to use in individuals with a history of heart disease, high blood pressure, diabetes, thyroid disease, or those experiencing difficulty urinating due to an enlarged prostate gland.

Patients should adhere strictly to the recommended dosage guidelines. The product should not be used for more than three consecutive days, as prolonged or excessive use may lead to a rebound effect, resulting in worsened nasal congestion. Users may experience temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it is important to note that sharing this product among multiple users may facilitate the spread of infection.

In the event that symptoms persist despite use, patients are advised to discontinue use and consult a healthcare provider for further evaluation.

In cases of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge. These reactions are generally mild and transient.

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

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

Packaging configurations for Afrin Original Nasal.
Details

Pediatric Use

Pediatric patients under 6 years of age should consult a healthcare professional before use. For children aged 6 to under 12 years, the recommended dosage is 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. Adult supervision is advised during administration for this age group.

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 no specific data available regarding the excretion of this medication in 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 urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific condition.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

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 the use of the product. Additionally, it has been reported that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

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 to stop using the product and consult a doctor if symptoms persist. When using this product, it is crucial to adhere to the following guidelines: patients should not exceed the directed dosage and should not use the product for more than three days. Emphasize that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Inform patients that temporary discomfort, such as burning, stinging, sneezing, or an increase in nasal discharge, may occur during use. Additionally, caution should be given regarding the use of this container by more than one person, as it may facilitate the spread of infection.

Healthcare providers should also recommend that patients consult a doctor before using this product 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 a carton that should be retained for future reference regarding the full labeling. It is essential to store the product at a temperature range of 20° to 25°C (68° to 77°F) to ensure its stability and efficacy.

After each use, the nozzle must be wiped clean to maintain hygiene and prevent contamination. Additionally, the cap should be securely fastened after use to protect the product from external factors.

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 prior to use.

Clinicians should counsel patients to seek medical advice before use if they have a history of heart disease, high blood pressure, diabetes, thyroid disease, or urinary issues related to an enlarged prostate. Pregnant or breastfeeding individuals should also consult a healthcare professional before use. It is important to keep the medication out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Afrin Original 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 Afrin Original 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

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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.