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Sinufrin Plus

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Active ingredient
Oxymetazoline Hydrochloride 7.5 mg/15 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 2012
Label revision date
January 11, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride 7.5 mg/15 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 2012
Label revision date
January 11, 2024
Manufacturer
NeilMed Pharmaceuticals, Inc.
Registration number
M012
NDC root
13709-232
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 various conditions, including the common cold, sinusitis (inflammation of the sinuses), hay fever (allergic rhinitis), and upper respiratory allergies. By targeting the underlying causes of nasal congestion, it helps you breathe more easily when you're feeling stuffy or blocked up.

Uses

If you're dealing with nasal congestion from a common cold, sinusitis, hay fever, or upper respiratory allergies, this medication can help provide temporary relief. It works by easing the swelling in your nasal passages, making it easier for you to breathe.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so you can use it without worrying about that aspect.

Dosage and Administration

When using this medication, adults and children aged 6 to 12 years (with adult supervision) should take 2 sprays in each nostril. You can do this no more than every 10 to 12 hours, and it's important not to exceed 2 doses in a 24-hour period.

If you have a child under 6 years of age, it's essential to consult a doctor before using this medication to ensure it's safe and appropriate for them. Always follow these guidelines to use the medication effectively and safely.

What to Avoid

You should avoid using this product if you have heart disease, high blood pressure, thyroid disease, or diabetes unless your doctor has specifically directed you to do so. Additionally, adult males with prostate disease should not use this product.

It's important to use this product only as directed and not for more than three consecutive days. Prolonged use may lead to worsening nasal congestion. If your symptoms persist after three days, stop using the product and consult your doctor.

Side Effects

You may experience some temporary discomfort when using this product, such as burning, stinging, sneezing, or an increase in nasal discharge. It's important to note that sharing this container with others can lead to the spread of infection. If your nasal congestion lasts more than three days, you should stop using the product and consult a doctor.

Additionally, if you have prostate disease, heart disease, high blood pressure, thyroid disease, or diabetes, you should avoid using this product unless directed by a healthcare professional. Be cautious not to use it for more than three consecutive days, as frequent or prolonged use can lead to worsening nasal congestion. Always follow the usage instructions carefully.

Warnings and Precautions

This product may cause some temporary discomfort, including burning, stinging, sneezing, or increased nasal discharge. It's important to use this product only as directed and not for more than three consecutive days. Frequent or prolonged use can lead to worsening nasal congestion. If your symptoms persist after three days, please stop using the product and consult your doctor.

To ensure safety, keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately. If you have heart disease, high blood pressure, thyroid disease, or diabetes, do not use this product unless directed by your doctor. Additionally, adult males with prostate disease should avoid using it. Remember, sharing this product with others can spread infections, so it's best to use it alone.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult your healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you may consider during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult your healthcare professional before using any medication. They can provide guidance on safety and any potential effects on your milk production or your baby. Always prioritize open communication with your healthcare provider to ensure the best outcomes for you and your child.

Pediatric Use

When using this medication for children aged 6 to 12 years, you can administer 2 sprays in each nostril, but make sure to do this no more than every 10 to 12 hours. It's important not to exceed 2 doses within a 24-hour period. For children under 6 years old, you should consult a doctor before use to ensure safety and proper guidance. Always supervise your child during administration to ensure they are using the medication correctly.

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 since older individuals may have different health needs and responses to treatments.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

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 in a cool, dry place at a temperature between 20 to 40 °C (68 to 104 °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 and 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 will administer this medication through the nasal route. If you are pregnant or breastfeeding, it’s important to consult your healthcare professional before using this medication to ensure it is safe for you and your baby.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves nasal congestion due to common cold, sinusitis, hay fever, and upper respiratory allergies.

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

For adults and children aged 6 to 12 years (with adult supervision), the recommended dosage is 2 sprays in each nostril not more than every 10 to 12 hours, with a maximum of 2 doses in any 24-hour period.

What should I do if I have heart disease or high blood pressure?

Do not use this product if you have heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.

Can children under 6 years use this product?

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

How long can I use this product?

Do not use this product for more than 3 consecutive days. If symptoms persist after 3 days, stop use and consult a doctor.

What are the potential side effects of this drug?

This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge.

What should I do if I accidentally swallow this product?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Is this drug safe to use during pregnancy or breastfeeding?

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

What precautions should I take while using this product?

Keep your head in an upright position while using the spray, do not tilt your head backward, and wipe the nozzle clean after each use.

What happens if I use this product frequently?

Frequent or prolonged use may cause nasal congestion to recur or worsen.

Packaging Info

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

Packaging configurations for Sinufrin Plus.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, sinusitis, hay fever, and upper respiratory allergies.

There are no teratogenic or nonteratogenic effects reported for this medication.

Dosage and Administration

For adults and children aged 6 to 12 years, the recommended dosage is 2 sprays in each nostril, administered not more frequently than every 10 to 12 hours. It is important to ensure that the total number of doses does not exceed 2 in any 24-hour period.

For children under 6 years of age, it is advised to consult a healthcare professional prior to administration.

Contraindications

This product is contraindicated in patients with the following conditions:

Use is not recommended in individuals with heart disease, high blood pressure, thyroid disease, or diabetes unless specifically directed by a healthcare professional. Additionally, adult males with prostate disease should not use this product.

Prolonged use may lead to a recurrence or worsening of nasal congestion. It is advised not to use this product for more than 3 consecutive days. If symptoms of nasal congestion persist after 3 days, discontinue use and consult a doctor.

Warnings and Precautions

This product may induce temporary discomfort, including sensations of burning, stinging, sneezing, or an increase in nasal discharge. Healthcare professionals should advise patients to be aware of these potential side effects.

To prevent the spread of infection, it is crucial that this product is not shared among multiple users. Additionally, it is imperative to keep this product 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.

The product should not be used for more than three consecutive days. It is essential to use this product strictly as directed; frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. If symptoms persist beyond three days, patients should be instructed to consult a healthcare provider.

Particular caution is warranted for adult males with prostate disease, as the use of this product is contraindicated in this population. Furthermore, individuals with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, or diabetes should refrain from using this product unless specifically directed by a healthcare professional.

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.

In clinical practice, patients are advised to discontinue use and consult a doctor if symptoms of nasal congestion persist after 3 days. Additionally, adult males with prostate disease should refrain from using this product. The product is not intended for use beyond 3 consecutive days and should be used strictly as directed.

Frequent or prolonged use of this product may result in the recurrence or worsening of nasal congestion. Patients with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, or diabetes should avoid using this product unless directed by a healthcare professional.

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. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

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

Packaging configurations for Sinufrin Plus.
Details

Pediatric Use

Pediatric patients aged 6 to 12 years may receive 2 sprays in each nostril per dose, administered no more frequently 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, it is advised to consult a doctor 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 potential 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 discuss their individual circumstances with their healthcare provider to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare 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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 available information.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution when administering the medication.

It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing. In the event of suspected overdosage, immediate medical attention should be sought.

Healthcare providers should implement standard supportive measures, which may include symptomatic treatment and monitoring of vital signs. Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

Documentation of the incident and any interventions undertaken is crucial for ongoing patient care and safety.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For individuals who are pregnant or breastfeeding, it is advised to consult a healthcare professional prior to use. Additionally, there is no information provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified that the use of this product may result in temporary discomfort, which can include symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. Additionally, it has been reported that the use of this container by more than one individual may pose a risk of spreading infection.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for use beyond 3 consecutive days. It is crucial to use the product only as directed, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. If symptoms persist after 3 days of use, patients should be instructed to stop using the product and consult a doctor.

Adult males with prostate disease should be cautioned against using this product. Additionally, patients should be advised to maintain an upright head position during use and to avoid tilting their head backward while spraying. It is also important for patients to wipe the nozzle clean after each use to ensure proper hygiene.

Finally, healthcare providers should emphasize that this product should not be used by individuals with heart disease, high blood pressure, thyroid disease, or diabetes unless specifically directed by a doctor.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers, which should be referenced for identification. It is essential to store the product within a temperature range of 20 to 40 °C (68 to 104 °F) to ensure its stability and efficacy.

Healthcare professionals are advised to retain the carton for future reference, as it contains important information regarding the full labeling of the product. Special handling requirements should be observed to maintain the integrity of the product during storage and use.

Additional Clinical Information

The route of administration for the medication is nasal. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Sinufrin Plus, 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 Sinufrin Plus, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.