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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 2018
Label revision date
September 12, 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 2018
Label revision date
September 12, 2024
Manufacturer
CVS Pharmacy
Registration number
M012
NDC root
69842-648
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 nasal decongestant available as a nasal spray. It is designed to temporarily relieve nasal congestion, sinus congestion, and sinus pressure, as well as reduce swelling in the nasal membranes. This fast-acting spray can help you feel more comfortable when dealing with nasal congestion caused by conditions such as the common cold, hay fever, or upper respiratory allergies.

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 make sure not to do this 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 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 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 return or worsening of nasal congestion. Always follow these guidelines to ensure your safety and the 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 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 dose 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 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 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. For adults and children aged 12 years 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 safe and effective use.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 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 any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

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 4 hours, but if you are under 12 years old, you should consult a doctor first. If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this product. Be cautious, as sharing this container with others may 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%?

PHENYLEPHRINE HCl 1% is a nasal decongestant available as a nasal spray.

What does PHENYLEPHRINE HCl 1% relieve?

It temporarily relieves nasal congestion, sinus congestion, sinus pressure, and swollen nasal membranes due to 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 every 4 hours, not exceeding the recommended dosage.

What should I do if I experience discomfort while using this product?

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

Are there any warnings associated with PHENYLEPHRINE HCl 1%?

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

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

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

How should I store PHENYLEPHRINE HCl 1%?

Store the product at 20°-25°C (68°-77°F).

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

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

Is there a limit to how long I can use PHENYLEPHRINE HCl 1%?

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

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 HCl 1% is a nasal decongestant formulated as a nasal spray. Each package contains one bottle with a total volume of 1 fluid ounce (30 mL). The product is designed for the relief of 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.

To ensure 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 maintain hygiene and prevent contamination.

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 a rebound effect, resulting in worsening nasal congestion.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product, particularly in patients with specific underlying health conditions. It is imperative to advise patients to consult a physician prior to use if they have a history of heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

When utilizing this product, adherence to the following precautions is essential to ensure safe and effective use. Patients should not exceed the recommended dosage and should refrain from using the product for more than three consecutive days. Prolonged or frequent use may lead to a rebound effect, resulting in worsened nasal congestion. It is crucial to instruct patients to use the product strictly as directed. Temporary side effects, including burning, stinging, sneezing, or increased nasal discharge, may occur during use. Additionally, sharing this product among multiple users is discouraged, as it may facilitate the spread of infection.

Patients should be advised to discontinue use and consult a healthcare provider 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.

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 (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 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 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 considered, 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 a healthcare provider 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 specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use if they experience difficulty urinating due to an enlarged prostate gland. This precaution is essential to ensure appropriate management and to mitigate potential complications associated with reduced kidney function. Monitoring and dosing adjustments may be necessary based on individual renal status and clinical judgment.

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. Contacting a Poison Control Center is recommended, with the national hotline available at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and initiate appropriate management procedures based on the severity of symptoms presented.

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 specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 crucial 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 upon request. 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 professional is recommended 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 inform patients 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, 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.