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Nasal

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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 2014
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 2014
Label revision date
October 4, 2024
Manufacturer
Kroger Company
Registration number
M012
NDC root
30142-539
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 Hydrochloride 1% is a nasal decongestant that helps relieve nasal congestion caused by conditions such as the common cold, hay fever, and upper respiratory allergies. It works quickly to provide relief from symptoms like swollen nasal membranes, sinus congestion, and sinus pressure, typically lasting for about four hours.

This medication is designed for fast-acting relief, making it a convenient option when you're feeling congested. If you're looking for a way to ease your breathing and clear your nasal passages, Phenylephrine Hydrochloride 1% may be a suitable choice.

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 firm, quick pressure while inhaling. After each use, remember to wipe the nozzle clean to ensure it stays hygienic and effective.

What to Avoid

It's important to use this medication responsibly. You should not take more than the directed amount, and avoid using it for more than three days. Using it for a longer period can lead to a rebound effect, where your nasal congestion may return or worsen.

Always prioritize your health by following these guidelines closely. If you have any questions or concerns about your use of this medication, consider discussing them with your healthcare provider.

Side Effects

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

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

Warnings and Precautions

Before using this 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 follow these guidelines to ensure the safety and well-being of your child.

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 considering potential changes in health or how the body processes drugs as we age.

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 needs and any other medications being taken. Always prioritize open communication with your doctor 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 necessary 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 medication 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 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 clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

You can use this medication by spraying 2 or 3 times in each nostril every four 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 Hydrochloride 1% used for?

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

How does Phenylephrine Hydrochloride work?

It acts quickly to relieve nasal congestion, swollen nasal membranes, sinus congestion, and sinus pressure, providing relief for up to 4 hours.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should use 2 or 3 sprays in each nostril not more often than every 4 hours.

What should I do if I am under 12 years old?

If you are under 12 years old, you should ask a doctor before using this product.

Are there any side effects associated with this medication?

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

What precautions should I take before using Phenylephrine Hydrochloride?

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

How long can I use Phenylephrine Hydrochloride?

You should not use it for more than 3 days, as frequent or prolonged use may worsen nasal congestion.

What should I do if symptoms persist?

Stop use and ask a doctor if symptoms persist.

What should I do in case of accidental ingestion?

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

Is it safe to use Phenylephrine Hydrochloride during pregnancy or breastfeeding?

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

Packaging Info

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

Packaging configurations for Nasal.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Phenylephrine Hydrochloride 1% is a nasal decongestant formulated for topical administration. Each unit contains 1 fluid ounce (30 mL) of the solution, designed to relieve nasal congestion.

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 proper hygiene and functionality.

Contraindications

There are no explicit contraindications identified for this product. However, it is advised that the product should not be used in excess of the directed dosage or for a duration exceeding three days. Prolonged or frequent use may lead to a rebound effect, resulting in worsening nasal congestion.

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 following general precautions:

  • The product should not be used in excess of the recommended dosage.

  • It is not intended for use beyond a duration of three days, as frequent or prolonged use may lead to a rebound effect, causing nasal congestion to return or worsen.

  • The product must be used strictly as directed to minimize risks.

  • Users may experience temporary discomfort, which can include burning, stinging, sneezing, or an increase in nasal discharge.

  • To prevent the spread of infection, this container should not be used by multiple individuals.

Patients should be instructed to discontinue use and consult a healthcare provider if symptoms persist despite treatment.

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 essential 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

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

Packaging & NDC

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

Packaging configurations for Nasal.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents 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. 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 the safety of both the mother 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 difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the patient's specific renal status.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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 the appropriate steps 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. No relevant information regarding nonclinical toxicology or animal pharmacology and toxicology is available in the insert.

Postmarketing Experience

No postmarketing experience details are available in the provided 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: patients should not exceed the directed dosage and should 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 they should be aware that temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur during use. Additionally, inform patients that sharing this container with others may increase the risk of spreading infection.

Healthcare providers should also recommend that patients consult a doctor before using this product if they have any of the following conditions: heart disease, 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, consultation with a healthcare provider is recommended before use.

Clinicians should counsel patients on important safety information, including the necessity of consulting a health professional if pregnant or breastfeeding. It is also crucial to inform patients that sharing the container may lead to the spread of infection. 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.

Drug Information (PDF)

This file contains official product information for 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 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

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.