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Topcare Nasal Four

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Active ingredient
Phenylephrine Hydrochloride 1 g/100 mL
Other brand names
Drug class
alpha-1 Adrenergic Agonist
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 2002
Label revision date
October 4, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 1 g/100 mL
Other brand names
Drug class
alpha-1 Adrenergic Agonist
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 2002
Label revision date
October 4, 2024
Manufacturer
Topco Associates LLC
Registration number
M012
NDC root
36800-648
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

Nasal Four is a nasal spray that acts as a decongestant, designed to temporarily relieve nasal congestion. Its active ingredient, phenylephrine HCl (a medication that helps reduce swelling in the nasal passages), works by relieving swollen nasal membranes and alleviating sinus congestion and pressure.

This fast-acting spray is indicated for relief from nasal congestion caused by common colds, hay fever, and upper respiratory allergies. With a volume of 1 fluid ounce (30 mL), Nasal Four provides a convenient option for those seeking quick relief from nasal discomfort.

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 easing the swelling in your nasal passages, making it easier for you to breathe.

You can use this medication when you're feeling stuffy and need a quick way to clear your nose. It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

When using this medication, adults and children aged 12 years and older should take 2 or 3 sprays in each nostril. You can do this every 4 hours, but make sure not to exceed that frequency. If you are considering this medication for a child under 12 years old, it’s important to consult a doctor first.

To use the spray correctly, keep your head in a normal, upright position. Insert the tip of the atomizer into your nostril, then squeeze the bottle with a firm, quick pressure while inhaling. After each use, remember to wipe the nozzle clean to keep it hygienic and functioning properly.

What to Avoid

It's important to use this medication responsibly. You should not use it for more than three days, as frequent or prolonged use may lead to a return or worsening of nasal congestion. Always follow the directions provided and avoid using more than the recommended amount to ensure your safety and effectiveness of the treatment.

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 not last long.

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

Warnings and Precautions

Before using this product, it's important to consult your doctor if you have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

While using this product, make sure to follow the directions carefully. Do not exceed the recommended dosage or use it for more than three days, as doing so may worsen nasal congestion. You might experience temporary discomfort, such as burning, stinging, sneezing, or increased nasal discharge. Additionally, sharing this product with others can lead to the spread of infection.

If your symptoms do not improve, stop using the product and contact your doctor. In case of accidental swallowing, seek emergency medical help or call a Poison Control Center immediately 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 may include unusual symptoms, but specific details about these symptoms are not provided here. If you notice anything concerning, 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

If you are considering using this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. This ensures that the treatment is safe and appropriate for their specific needs.

For adults and children aged 12 years and older, the recommended dosage is 2 or 3 sprays in each nostril, but it should not be used more often than every 4 hours. Always follow these guidelines to ensure safe and effective use.

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. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°-25°C (68°-77°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

You can use this medication as follows: for adults and children aged 12 years and older, spray 2 or 3 times in each nostril, but do not do this more often than every 4 hours. If the patient is under 12 years old, consult a doctor for guidance.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. Be aware that sharing this container with others can lead to the spread of infection. In case of accidental swallowing, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is Nasal Four?

Nasal Four is a nasal spray that acts as a nasal decongestant, containing 1% PHENYLEPHRINE HCl as its active ingredient.

What does Nasal Four relieve?

It temporarily relieves nasal congestion, swollen nasal membranes, sinus congestion, and sinus pressure due to common cold, hay fever, and upper respiratory allergies.

How should I use Nasal Four?

For adults and children 12 years and over, use 2 or 3 sprays in each nostril every 4 hours as needed. For children under 12, consult a doctor.

Are there any side effects of using Nasal Four?

Temporary discomfort such as burning, stinging, sneezing, or increased nasal discharge may occur. If symptoms persist, stop use and consult a doctor.

What precautions should I take before using Nasal Four?

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

Can I use Nasal Four if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Nasal Four.

How should I store Nasal Four?

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

What should I do if I accidentally swallow Nasal Four?

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

How long can I use Nasal Four?

Do not use Nasal Four for more than 3 days, as frequent or prolonged use may worsen nasal congestion.

Packaging Info

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

Packaging configurations for Topcare Nasal Four.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

TopCare health is a nasal spray formulation designed as a nasal decongestant. It contains 1% phenylephrine hydrochloride as the active ingredient. The product is available in a volume of 1 fluid ounce (30 mL). This formulation is comparable to the active ingredient found in 4-WAY® Fast Acting Nasal Spray.

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.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to administer 2 or 3 sprays in each nostril, not to exceed every 4 hours. For children under 12 years of age, it is recommended to consult a physician prior to use.

For proper administration, the patient should maintain a normal, upright head position. The atomizer tip should be inserted into the nostril, and the bottle should be squeezed with firm, quick pressure while inhaling. It is important to wipe the nozzle clean after each use to ensure hygiene and proper functioning of the device.

Contraindications

Use is contraindicated in patients who exceed the directed dosage or utilize the product for more than three consecutive days. Prolonged or frequent use may lead to a rebound effect, resulting in worsening nasal congestion.

Warnings and Precautions

Healthcare professionals should advise patients to consult a physician prior to using this product if they have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

When utilizing this product, it is imperative to adhere strictly to the recommended dosage. Patients should not exceed the directed use and should refrain from using the product for more than three consecutive days. Prolonged or frequent use may lead to a rebound effect, causing nasal congestion to return or worsen. Users should be informed that temporary discomfort, including burning, stinging, sneezing, or an increase in nasal discharge, may occur during use. Additionally, sharing this container with others may pose a risk of spreading infection.

Patients must be instructed to discontinue use and consult a healthcare provider if symptoms persist. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Side Effects

Patients using this product may experience temporary discomfort, which can include sensations of 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

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Topcare Nasal Four.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended dosage is 2 or 3 sprays in each nostril, not to be administered more frequently than every 4 hours.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 difficulties with urination due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for guidance on appropriate actions to take.

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.

Postmarketing Experience

No postmarketing experience details are available in the extracted data.

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 at 1-800-222-1222.

Patients should be informed to stop using the product and consult a doctor if symptoms persist. When using this product, it is essential to adhere to the following guidelines: do not exceed the recommended dosage, and do not use the product for more than three consecutive days, as frequent or prolonged use may lead to a rebound effect, causing nasal congestion to return or worsen. Patients should use the product only as directed and be aware that temporary discomfort, such as burning, stinging, sneezing, or an increase in nasal discharge, may occur. Additionally, inform patients that sharing this container with others may increase the risk of spreading infection.

Healthcare providers should also encourage patients to consult a doctor before using this product if they have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Care should be taken to ensure that the product is kept within this temperature range to maintain its integrity and efficacy.

Additional Clinical Information

Patients aged 12 years and older are advised to administer 2 or 3 sprays in each nostril, not exceeding every 4 hours. For children under 12 years, it is recommended to consult a doctor regarding the appropriate use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to note that sharing the container with others may lead to the spread of infection. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Topcare Nasal Four, 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 Nasal Four, 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.