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Nasal Decongestant Pe

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Active ingredient
Phenylephrine Hydrochloride 10 mg
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
March 1, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 10 mg
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Tablet
Route
Oral
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 2025
Label revision date
March 1, 2025
Manufacturer
Bi-Mart
Registration number
M012
NDC root
37835-651
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 is a non-drowsy nasal decongestant that contains 10 mg of the active ingredient, phenylephrine hydrochloride. It is designed to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies, as well as to alleviate sinus congestion and pressure.

This medication is available in a package of 36 tablets and works by narrowing the blood vessels in the nasal passages, which helps to reduce swelling and congestion. If you're looking for relief from nasal discomfort, phenylephrine HCl may be a suitable option for you.

Uses

If you're dealing with nasal congestion from the common cold, hay fever, or other 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.

Additionally, if you're experiencing sinus congestion and pressure, this medication can also help alleviate those symptoms. It's designed to give you some comfort when you're feeling under the weather.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 tablet every 4 hours as needed. However, it's important not to exceed 6 tablets in a 24-hour period to ensure your safety.

For children under 12 years of age, it's best to consult a doctor before giving them this medication. They can provide guidance on the appropriate dosage and ensure it's safe for your child's specific needs. Always follow these instructions carefully to use the medication effectively and safely.

What to Avoid

It's important to use this product responsibly. Make sure you do not exceed the recommended dose, as taking more than advised can lead to unwanted effects. While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always prioritize your health and safety by following the guidelines provided. If you have any questions or concerns about using this product, consider discussing them with a healthcare professional.

Side Effects

You should be aware of some potential side effects when using this medication. Common reactions may include nervousness, dizziness, or sleeplessness. If you experience any of these symptoms, it's important to stop using the medication and consult your doctor. Additionally, if your symptoms do not improve within 7 days or if you develop a fever, seek medical advice.

Before starting this medication, talk to your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. Also, do not use this medication if you are currently taking a monoamine oxidase inhibitor (MAOI) or have taken one in the past two weeks, as this can lead to serious interactions.

Warnings and Precautions

You should not use this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of drug used for depression, psychiatric conditions, or Parkinson's disease. Additionally, you must wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your prescription contains an MAOI, please consult your doctor or pharmacist.

If you suspect an overdose, it is crucial to seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop taking this medication and call your doctor if you experience nervousness, dizziness, or sleeplessness. Also, if your symptoms do not improve within seven days or if they occur alongside a fever, please reach out to your doctor for further guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts about your 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 one tablet every four hours, but be sure not to exceed six tablets in a 24-hour period. 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 a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to be cautious about combining medications. You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, certain psychiatric conditions, or Parkinson's disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your current medication includes an MAOI, it's best to consult with your doctor or pharmacist.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health is a priority, and your provider can help you navigate any concerns.

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). It's important to keep it away from excessive moisture, as this can affect its quality.

Before using the product, check that the printed seal under the cap is intact. If the seal is missing or damaged, do not use the product, as this could compromise its safety and effectiveness. Always handle the product with care to maintain its integrity.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period. If the patient is under 12 years old, it's important to consult a doctor for appropriate dosing guidance.

FAQ

What is Phenylephrine HCl?

Phenylephrine HCl is a non-drowsy nasal decongestant that contains 10 mg of the active ingredient and is available in a package of 36 tablets.

What conditions does Phenylephrine HCl relieve?

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

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

Adults and children 12 years and over should take 1 tablet every 4 hours, not exceeding 6 tablets in 24 hours.

What should I do if I am pregnant or breastfeeding?

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

Are there any contraindications for using Phenylephrine HCl?

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if I experience side effects?

Stop using Phenylephrine HCl and ask a doctor if you experience nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days or occur with a fever.

How should I store Phenylephrine HCl?

Store the tablets between 20°-25°C (68°-77°F) and protect them from excessive moisture. Do not use if the printed seal under the cap is missing or damaged.

Packaging Info

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

Packaging configurations for Nasal Decongestant Pe.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product contains Phenylephrine HCl at a concentration of 10 mg per tablet, serving as a nasal decongestant. It is indicated for the relief of nasal and sinus congestion as well as sinus pressure. The formulation is designed to be non-drowsy. Each package contains 36 tablets. The product is identified by NDC 37835-651-36 and is comparable to the active ingredients found in Sudafed PE® Sinus Congestion. It is important to note that this product is not manufactured or distributed by the owner of the registered trademark Sudafed PE® Sinus Congestion.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion associated with the common cold, 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

Adults and children aged 12 years and over are advised to take 1 tablet every 4 hours as needed. The maximum allowable dosage is 6 tablets within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dose. Adherence to dosing guidelines is essential to mitigate potential risks associated with overdose. No other specific contraindications have been identified in the available data.

Warnings and Precautions

Patients should not use this product concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the use of this product is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescribed medication, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

In the event of an overdose, immediate medical assistance should be sought. Patients are advised to contact a Poison Control Center at 1-800-222-1222 without delay.

Patients should discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within seven days or are accompanied by a fever, it is essential to stop taking the product and seek medical advice.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). It is crucial to avoid the use of this product in conjunction with MAOIs or within two weeks of stopping such medications, as this could lead to significant health risks.

Common adverse reactions that warrant immediate medical attention include nervousness, dizziness, and sleeplessness. Patients are advised to discontinue use and consult a healthcare professional if these symptoms arise. Additionally, if symptoms do not improve within seven days or are accompanied by a fever, medical advice should be sought.

Before using this product, patients with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland should consult a healthcare provider to ensure safe use.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson's disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI. It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to confirm whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Nasal Decongestant Pe.
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 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period.

Geriatric Use

There is no specific information 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. It is advisable to monitor these patients closely for any 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 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 have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be implemented as necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the variability in individual responses to medication.

Management Procedures In the absence of specific antidotes or treatment protocols, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on managing suspected overdosage cases. Continuous evaluation and supportive care remain paramount in ensuring patient safety and recovery.

Healthcare professionals are encouraged to report any cases of overdosage to the appropriate regulatory authorities to contribute to the ongoing assessment of the medication's safety profile.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's safety profile in nonclinical settings.

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. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be informed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and seek medical advice if symptoms do not improve within 7 days or if they occur alongside a fever.

It is important to emphasize that patients should not exceed the recommended dose while using this product. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 20°-25°C (68°-77°F) to maintain its integrity and efficacy.

To ensure optimal conditions, the product must be protected from excessive moisture. Additionally, it is critical to inspect the packaging prior to use; the product should not be utilized if the printed seal under the cap is missing or damaged, as this may compromise safety and effectiveness.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours, with a maximum of six tablets in a 24-hour period. For children under 12 years, it is advised to consult a doctor regarding appropriate dosing.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Nasal Decongestant Pe, 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 Decongestant Pe, 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.