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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 2014
Label revision date
November 7, 2018
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 2014
Label revision date
November 7, 2018
Manufacturer
Allegiant Health
Registration number
M012
NDC root
69168-272
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

You may be experiencing nasal congestion due to a common cold, hay fever, or other upper respiratory allergies. This decongestant is designed to temporarily relieve that congestion, helping you breathe more easily. It can also provide relief from sinus congestion and pressure, making it a helpful option if you're dealing with sinusitis.

Uses

If you're dealing with nasal congestion from a common cold, hay fever, or other upper respiratory allergies, this medication can provide temporary relief. It also helps alleviate nasal congestion that comes with sinusitis, as well as sinus congestion and pressure.

You can expect this treatment to help you breathe easier when you're feeling stuffed up, making it a useful option for managing your symptoms during allergy season or when you're under the weather.

Dosage and Administration

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

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 your healthcare provider's advice for the best results.

What to Avoid

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

It's also important to follow the dosage instructions carefully and not exceed the recommended amount. If you experience nervousness, dizziness, or sleeplessness while using this product, or if your symptoms do not improve within seven days or are accompanied by a fever, stop using it and consult your doctor.

Side Effects

If you experience nervousness, dizziness, or sleeplessness while using this medication, it's important to stop and consult your doctor. Additionally, if your symptoms do not improve within 7 days or are accompanied by a fever, seek medical advice.

Before using 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 prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks, as this can lead to serious interactions.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used 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 are unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist.

Before using this product, it’s important to 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 gland. Always follow the dosage instructions carefully and do not exceed the recommended amount.

If you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within seven days or are accompanied by a fever, stop using the product and contact your doctor. In the event of an accidental overdose, please call a Poison Control Center at 1-800-222-1222 immediately for assistance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your 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 your child is under 12 years old, it's important to consult with a doctor before giving them this medication. For those aged 12 and older, the recommended dosage is one tablet every 4 to 6 hours, but be sure not to exceed 6 tablets in a 24-hour period. Always follow these guidelines to ensure your child's safety and well-being.

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 potential risks or benefits with your healthcare provider. They can help determine the best course of action based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

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

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health and well-being are the top priority, so don't hesitate to ask questions about your treatments.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to protect it from light and keep the container tightly closed when not in use. Always keep the product out of reach of children to prevent accidental ingestion or misuse. Once opened, please remember to discard the product to maintain safety and quality.

Additional Information

You should take this medication as follows: for adults and children aged 12 years and older, the recommended dose is 1 tablet every 4 to 6 hours, with a maximum of 6 tablets in a 24-hour period. If the patient is under 12 years old, consult a doctor for the appropriate dosage.

If you are pregnant or breastfeeding, it's important to speak with a healthcare professional before using this medication to ensure it's safe for you and your baby.

FAQ

What is the drug classified as?

The drug is classified as a decongestant.

What conditions does this drug temporarily relieve?

It temporarily relieves nasal congestion due to the common cold, hay fever, upper respiratory allergies, and sinusitis.

What is the recommended dosage for adults and children 12 years and older?

The recommended dosage is 1 tablet every 4 to 6 hours, with a maximum of 6 tablets in 24 hours.

What should I do if I am under 12 years of age?

If you are under 12 years of age, you should ask a doctor before use.

Are there any contraindications for this drug?

Do not use this drug if you are currently taking a prescription mono-amine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if I experience side effects?

Stop use and ask a doctor if you get nervous, dizzy, or sleepless, or if symptoms do not improve within 7 days or are accompanied by fever.

Should I consult a doctor before using this drug if I have certain health conditions?

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

What should I do in case of accidental overdose?

In case of accidental overdose, contact a Poison Control Center at 1-800-222-1222 immediately.

What precautions should I take if I am pregnant or breastfeeding?

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

How should I store this drug?

Store at room temperature, between 20°C to 25°C (68°F to 77°F), protect from light, and keep out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Nasal Decongestant Pe (phenylephrine 10 mg). 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

The product identified by SPL Code 34089-3 is classified as a decongestant.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion due to the common cold, hay fever, or other upper respiratory allergies. It is also indicated for the temporary relief of nasal congestion associated with sinusitis, as well as for the temporary relief of sinus congestion and pressure.

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

Dosage and Administration

Adults and children 12 years of age and older are advised to take 1 tablet every 4 to 6 hours as needed. It is important not to exceed a total of 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 currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage is also contraindicated.

Patients should discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days or are accompanied by fever.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this product should not be used for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise patients to seek medical guidance before using this product 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.

During the use of this product, it is crucial that patients adhere strictly to the recommended dosage and not exceed the directed amount.

Patients are instructed to discontinue use and consult a healthcare provider if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, medical advice should be sought promptly.

In the event of an accidental overdose, it is essential to contact a Poison Control Center immediately at 1-800-222-1222 for assistance.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions warrant immediate medical attention and include symptoms such as nervousness, dizziness, or sleeplessness. Patients are advised to discontinue use and consult a healthcare professional if these symptoms occur. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, medical advice should be sought.

Common adverse reactions may arise in patients with pre-existing conditions. It is recommended that individuals with heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland consult a healthcare provider prior to use.

Furthermore, the medication should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should refrain from using this medication for at least 2 weeks after discontinuing an MAOI.

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, if there is uncertainty regarding the presence of an MAOI in their current prescription medications before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Nasal Decongestant Pe (phenylephrine 10 mg). 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 to 6 hours, with a maximum of 6 tablets in a 24-hour period. Caution is advised when administering to younger children, and appropriate medical guidance is essential.

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 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 on the excretion of this drug 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 individuals with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 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, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and ensuring hemodynamic stability.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring and supportive care are critical components in the management of overdose cases.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been provided in the insert. Additionally, there is no information available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to contact a Poison Control Center immediately at 1-800-222-1222 in the event of an accidental overdose. It is crucial to inform patients that this product should not be used if they are currently taking a prescription mono-amine oxidase inhibitor (MAOI) or within two weeks of stopping an MAOI medication. Patients should be encouraged to consult with their doctor or pharmacist if they are uncertain whether their prescription contains an MAOI.

Providers should also recommend that patients seek medical advice before using this product 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.

Patients must be instructed to adhere strictly to the recommended dosage and not to exceed the directed amount. They should be informed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness, or if their symptoms do not improve within seven days or are accompanied by fever.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to ensure its efficacy. Additionally, the product should be kept out of reach of children, and any unused portion should be discarded after opening to prevent potential contamination or degradation.

Additional Clinical Information

Patients aged 12 years and older are advised to take 1 tablet every 4 to 6 hours, with a maximum of 6 tablets in a 24-hour period. For children under 12 years of age, consultation with a doctor is recommended prior to administration.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding before using the medication. No additional information is available regarding laboratory tests, abuse potential, 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.