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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 2003
Label revision date
November 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 2003
Label revision date
November 4, 2024
Manufacturer
Meijer Distribution Inc
Registration number
M012
NDC root
41250-648
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

Phenylephrine HCl 1% is a fast-acting nasal decongestant available as a nasal spray. It is designed to temporarily relieve nasal congestion caused by conditions such as the common cold, hay fever, and upper respiratory allergies. By targeting swollen nasal membranes, it helps alleviate sinus congestion and pressure, providing quick relief when you need it most.

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 stuffiness and discomfort you may be experiencing, allowing you to breathe more easily.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

When using this medication, adults and children aged 12 years and older should spray 2 or 3 times into each nostril, but not more often than every 4 hours. If you are giving this medication to a child under 12 years old, it’s important to consult a doctor first for guidance.

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 firm, quick pressure while inhaling. After each use, make sure to wipe the nozzle clean to keep it hygienic and functioning properly.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should not use it for more than three days, as frequent or prolonged use can lead to a return or worsening of nasal congestion. Always follow the directions provided and avoid using more than the recommended amount. Taking these precautions will help you use the medication effectively while minimizing potential issues.

Side Effects

You may experience some temporary discomfort while using this product, which can include 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 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. Always 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 like 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 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 may include unusual symptoms, but specific details on 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 have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, the recommended dosage is 2 or 3 sprays in each nostril, but this should not be done more frequently than every 4 hours. Always ensure you follow these guidelines to keep your child safe and 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 medications with a healthcare provider, especially since older individuals may have different health needs and responses to drugs.

Always ensure that your doctor is aware of any other medications being taken, as well as any existing health conditions. This will help them determine the safest and most effective treatment plan for you.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to your treatment plan.

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 may affect you 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 helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

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. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can use this medication by spraying 2 or 3 times in each nostril every 4 hours if you are an adult or a child aged 12 years and older. If your child is under 12, consult a doctor for guidance on the appropriate use.

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 Phenylephrine HCl 1% used for?

Phenylephrine HCl 1% is a nasal decongestant that temporarily relieves nasal congestion due to the common cold, hay fever, and upper respiratory allergies.

How should I use Phenylephrine HCl 1%?

For adults and children 12 years and over, use 2 or 3 sprays in each nostril not more often than every 4 hours. For children under 12 years, ask a doctor.

Are there any side effects of using Phenylephrine HCl 1%?

Temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur. If symptoms persist, stop use and ask a doctor.

Can I use Phenylephrine HCl 1% if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using Phenylephrine HCl 1%.

What precautions should I take when using Phenylephrine HCl 1%?

Do not use more than directed or for more than 3 days, as frequent or prolonged use may worsen nasal congestion. Also, avoid sharing the container to prevent spreading infection.

What should I do if I accidentally swallow Phenylephrine HCl 1%?

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

What storage conditions are recommended for Phenylephrine HCl 1%?

Store Phenylephrine HCl 1% at 20°-25°C (68°-77°F).

Packaging Info

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

Packaging configurations for Nasal Four.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Phenylephrine HCl 1% is a nasal decongestant formulated as a nasal spray. This product is designed to provide fast relief from nasal congestion, swollen nasal membranes, sinus congestion, and sinus pressure. Each bottle contains 1 fluid ounce (30 mL) of the solution, ensuring a convenient dosage form for effective administration.

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 of this product is contraindicated in patients who exceed the recommended dosage or duration of use. Specifically, it should not be used for more than three consecutive days, as frequent or prolonged use may lead to rebound nasal congestion or exacerbation of symptoms.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

Patients should be advised to consult a physician prior to use 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. These conditions may influence the safety and efficacy of the product.

When administering this product, it is crucial to adhere to the recommended guidelines. Patients should not exceed the directed dosage 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. It is essential to use the product strictly as directed to minimize the risk of adverse effects. 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 infection transmission.

Healthcare providers should instruct patients to discontinue use and seek medical advice if symptoms persist.

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. Prompt action is necessary to ensure patient safety.

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

Packaging & NDC

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

Packaging configurations for Nasal Four.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children 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

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. 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 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 have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 insert text.

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 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 accordance with the following specifications. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

No specific container requirements or special handling needs have been indicated; however, adherence to the recommended temperature range is crucial for optimal product performance.

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 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 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.