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Topcare Sinus Nasal

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Active ingredient
Oxymetazoline Hydrochloride .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 2018
Label revision date
November 7, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride .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 2018
Label revision date
November 7, 2024
Manufacturer
Topco Associates LLC
Registration number
M012
NDC root
36800-711
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

TopCare is a sinus nasal spray designed to provide temporary relief from nasal congestion caused by colds, hay fever, or other upper respiratory allergies. Its active ingredient, oxymetazoline HCl (a medication that helps reduce swelling in the nasal passages), works effectively to alleviate sinus congestion and pressure, offering up to 12 hours of relief.

This ultra-fine mist formulation also contains menthol, which can enhance the soothing effect. With its fast and powerful action, TopCare is a helpful option for those seeking to ease their nasal discomfort.

Uses

If you're dealing with nasal congestion from a cold, hay fever, or other upper respiratory allergies, this medication can help provide temporary relief. It also works to ease sinus congestion and pressure, making it easier for you to breathe comfortably.

You can rely on this treatment to help alleviate those bothersome symptoms, allowing you to feel more at ease during your recovery.

Dosage and Administration

Before using your medication, make sure to shake the container well. If you have white tabs, squeeze the grooved area of the cap firmly and turn it counterclockwise to open. For first-time use, you’ll need to prime the pump by pressing its rim several times until you see a spray.

When you’re ready to use it, hold the container with your thumb at the base and the nozzle between your first and second fingers. Keep your head upright and gently insert the nozzle into one nostril. Fully press down on the rim with a firm, even stroke while inhaling deeply. After using the medication, remember to secure the cap tightly.

For adults and children aged 6 years and older (with adult supervision), you can use 2 or 3 sprays in each nostril, but make sure not to do this more than every 10 to 12 hours. It’s important not to exceed 2 doses in a 24-hour period. If you’re considering this medication for a child aged 2 to under 6 years, please consult a doctor first. For children under 2 years, do not use this medication.

What to Avoid

It's important to use this product responsibly to ensure your safety and well-being. You should never exceed the recommended dosage, as doing so can lead to unwanted effects. Additionally, avoid using this product for more than three days. Using it longer than directed may cause your nasal congestion to come back or even worsen.

Always follow the instructions provided and use the product only as directed to minimize any potential risks. If you have any concerns or questions about your use of this product, consider consulting a healthcare professional for guidance.

Side Effects

You may experience some temporary discomfort while using this product, such as burning, stinging, sneezing, or an increase in nasal discharge. If these symptoms persist, it's important to stop using the product and consult a doctor.

Before using this product, talk to your doctor if you have any of the following conditions: heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Remember not to exceed the recommended dosage or use the product for more than three days, as doing so may worsen nasal congestion. Additionally, sharing this product with others can spread infection, and if swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

Before using this product, it's important to consult your doctor if you have any of the following conditions: heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Always follow the recommended dosage and do not use the product for more than three days, as overuse can lead to worsening nasal congestion. You may experience temporary discomfort, such as burning, stinging, sneezing, or increased nasal discharge. Additionally, sharing this product with others can spread infections.

If your symptoms do not improve, stop using the product and contact your doctor. In case of accidental swallowing, seek medical help immediately or call a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice any concerning changes in behavior or health, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

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 considering this medication for your child, it's important to follow specific guidelines based on their age. For children aged 6 years and older, you can administer 2 or 3 sprays in each nostril, but make sure not to give it more often than every 10 to 12 hours, and do not exceed 2 doses in a 24-hour period.

If your child is between 2 and under 6 years old, it's best to consult with a doctor before use. For children under 2 years, this medication should not be used at all. Always prioritize your child's safety by adhering to these recommendations.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to 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 your kidney health and any medications you are considering.

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).

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 informed decisions about 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 of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, be sure to do so with care to avoid any damage. Always follow any specific instructions provided for use to ensure safety and proper function. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is TopCare?

TopCare is a sinus nasal spray that contains OXYMETAZOLINE HCl 0.05% and is formulated as an ultra fine mist.

What does TopCare relieve?

TopCare temporarily relieves nasal congestion due to a cold, hay fever, or other upper respiratory allergies, as well as sinus congestion and pressure.

How long does the relief last?

You can expect 12 hours of relief from nasal congestion when using TopCare.

What is the recommended dosage for adults and children 6 years and older?

The recommended dosage is 2 or 3 sprays in each nostril, not more often than every 10 to 12 hours, and do not exceed 2 doses in 24 hours.

Can children under 2 years use TopCare?

No, TopCare should not be used in children under 2 years of age.

What should I do if symptoms persist?

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

What are some possible side effects?

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

Are there any precautions I should take?

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

How should I store TopCare?

Store TopCare at a temperature between 20-25°C (68-77°F).

What should I do if I accidentally swallow TopCare?

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Packaging Info

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

Packaging configurations for Topcare Sinus Nasal.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Oxymetazoline hydrochloride 0.05% is a nasal spray formulation that includes menthol as an active ingredient. This product is designed to deliver an ultra-fine mist, providing effective nasal decongestion. Each bottle contains 1 fluid ounce (30 mL) of the solution, which offers up to 12 hours of relief from nasal congestion.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with colds, hay fever, or other upper respiratory allergies. Additionally, it provides temporary relief from sinus congestion and pressure.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be shaken well before use. For administration, the white tabs should be held while firmly squeezing the grooved area of the cap and turning it counterclockwise. Prior to the initial use, the pump must be primed by firmly depressing its rim several times.

To administer the medication, the container should be held with the thumb at the base and the nozzle positioned between the first and second fingers. The nozzle should be inserted into the nostril without tilting the head. The rim should be fully depressed with a firm, even stroke while inhaling deeply.

For adults and children aged 6 years and older, the recommended dosage is 2 or 3 sprays in each nostril, not to be administered more frequently than every 10 to 12 hours. The total dosage should not exceed 2 doses within a 24-hour period.

For children aged 2 to under 6 years, it is advised to consult a physician for appropriate dosing. The medication is not recommended for use in children under 2 years of age. After use, the cap should be secured to maintain the integrity of the product.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage or utilize it for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. It is essential to adhere strictly to the directed usage guidelines to avoid potential complications.

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, thyroid disease, diabetes, high blood pressure, or urinary difficulties due to an enlarged prostate gland.

When administering this product, adherence to the recommended dosage is crucial. Patients should not exceed the prescribed amount and should limit use to a maximum of three days. Prolonged or frequent use may lead to a recurrence or worsening of 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.

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

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

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

It is important for patients to stop using the product and consult a healthcare professional if symptoms persist. Additionally, patients should seek medical advice before using this product if they have a history of heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

Patients are advised not to exceed the recommended dosage and to refrain from using the product for more than three days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion. Furthermore, sharing this product among multiple users may increase the risk of spreading infections.

In the event of accidental ingestion, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Topcare Sinus Nasal.
Details

Pediatric Use

Pediatric patients aged 6 years and older may receive 2 or 3 sprays in each nostril, with administration not to exceed every 10 to 12 hours. The maximum dosage should not exceed 2 doses within a 24-hour period.

For children aged 2 to under 6 years, it is advised to consult a healthcare professional before use. The product is contraindicated in children under 2 years of age.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. 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 regarding the excretion of this medication 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 urinating due to an enlarged prostate gland. This precaution is essential to ensure safe and effective use of the medication in individuals with reduced kidney function.

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 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. The national Poison Control Center can be reached at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

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

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. Temporary discomfort may occur, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge.

No specific information regarding carcinogenicity, mutagenicity, or impairment of fertility is available in the insert. Additionally, there is no detailed data provided concerning animal pharmacology and toxicology.

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 use. Additionally, it has been reported that the use of this container by more than one person may facilitate the spread of infection.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to emphasize that patients should not exceed the recommended dosage and should not use the product for more than three days. Patients should be instructed to use the product only as directed, as frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patients may experience temporary discomfort, which can include symptoms such as burning, stinging, sneezing, or an increase in nasal discharge. Healthcare providers should inform patients that using this container by more than one person may increase the risk of spreading infection.

Additionally, healthcare providers should encourage patients to consult with a doctor before using the product if they have any of the following conditions: heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. This precaution is essential to ensure the safe use of the product in individuals with these health concerns.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Topcare Sinus 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 Topcare Sinus 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.