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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 2024
Label revision date
July 17, 2024
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 2024
Label revision date
July 17, 2024
Manufacturer
NUVICARE LLC
Registration number
M012
NDC root
84324-010
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

NC Nasal Decongestant is a medication designed to temporarily relieve sinus congestion and pressure. It works by alleviating nasal congestion caused by common colds, hay fever, or other upper respiratory allergies, helping you breathe more easily when you're feeling stuffy. This can provide much-needed comfort during times of illness or allergy flare-ups.

Uses

If you're dealing with sinus congestion and pressure, this medication can help provide temporary relief. It’s also effective for easing nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. This means you can breathe easier and feel more comfortable when you're experiencing these symptoms.

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 you need to take this medication, start by taking 1 tablet every 4 hours. It's important to keep track of how many tablets you take throughout the day. For adults and children aged 12 years and older, you should not exceed 6 tablets in a 24-hour period.

If you are considering this medication for a child under 12 years old, it's best to consult with a doctor first to ensure it's safe and appropriate for them. Always follow these guidelines to use the medication safely and effectively.

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

It's important to be aware of potential side effects when using this medication. You should stop using it and consult your doctor if you experience nervousness, dizziness, or sleeplessness. 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 gland. Also, do not use this medication if you are currently taking a monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. If you're unsure whether your prescription includes an MAOI, please ask your doctor or pharmacist.

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, 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 medication contains an MAOI, please consult your doctor or pharmacist.

In case of an overdose, it’s crucial to seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

If you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within seven days or occur alongside a fever, stop using the product and call your doctor right away.

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 unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

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 adults and children aged 12 and older, the maximum recommended dosage is 6 tablets within a 24-hour period. Always follow these guidelines to ensure safe use for 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. 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 best approach for you or your loved one, considering any existing health conditions or medications that may interact.

Remember, your safety and well-being are the top priority, so don’t hesitate to ask questions and discuss any concerns with your doctor.

Renal Impairment

If you have kidney issues, 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 for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

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 you understand how to manage your health while taking any medications.

Drug Interactions

It's crucial to be aware of potential interactions when taking medications. If you are currently using a prescription monoamine oxidase inhibitor (MAOI)—a type of medication often prescribed for depression, certain psychiatric conditions, or Parkinson's disease—you should not take 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 harmful interactions. Your health is important, and your provider can help you navigate any concerns regarding your treatments.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25 °C (68-77 °F). This temperature range helps maintain the product's effectiveness.

When handling the product, be sure to check that the seal under the cap is intact. If the seal is broken or missing, do not use the product, as this could compromise its safety and effectiveness. Always prioritize these storage and handling guidelines to ensure your safety and the product's reliability.

Additional Information

No further information is available.

FAQ

What is NC Nasal Decongestant used for?

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

How should I take NC Nasal Decongestant?

You should take 1 tablet every 4 hours, and adults and children 12 years and over should not exceed 6 tablets in 24 hours.

Are there any contraindications for NC Nasal Decongestant?

There are no explicit contraindications mentioned, but do not use it if you are 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 the product 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.

Is NC Nasal Decongestant safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using NC Nasal Decongestant.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

What are the storage instructions for NC Nasal Decongestant?

Store NC Nasal Decongestant between 20-25 °C (68-77 °F) and do not use it if the seal under the cap is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Nasal Decongestant Pe (phenylephrine hcl 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

PL0209-00 is a nasal decongestant available in a 100-count package. This formulation is designed to relieve nasal congestion. The product is intended for use in the management of symptoms associated with nasal congestion.

Uses and Indications

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

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

Dosage and Administration

The recommended dosage for adults and children aged 12 years and older is 1 tablet every 4 hours, with a maximum of 6 tablets within a 24-hour period. For children under 12 years of age, it is advised to consult a physician for appropriate dosing guidance.

Tablets should be taken orally, and it is important to adhere to the specified intervals to avoid exceeding the maximum daily limit.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage. Adhering to the specified dosage guidelines is essential to prevent potential adverse effects associated with overdose.

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 whether a prescription medication contains an MAOI, 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 is required. Patients should seek emergency medical help or contact a Poison Control Center at 1-800-222-1222 without delay.

Patients are advised to 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 seek medical advice promptly.

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). The use of this product is contraindicated in such cases, and patients are advised to consult a healthcare professional if they are uncertain whether their prescription includes an MAOI.

Common adverse reactions that warrant immediate medical attention include nervousness, dizziness, and sleeplessness. Patients experiencing these symptoms should discontinue use and seek medical advice. Additionally, if symptoms do not improve within 7 days or are accompanied by a fever, it is recommended that patients consult a healthcare provider.

Before using this product, patients should inform their healthcare provider 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. These pre-existing conditions may influence the safety and efficacy of the product.

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 any 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 hcl 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 and adults aged 12 years and older, the maximum recommended dosage is 6 tablets within a 24-hour period.

Geriatric Use

There is no specific information available 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 considered in these populations to ensure the safety of both the mother and the fetus or 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 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 to patients 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 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, healthcare professionals are advised to exercise caution and consider general principles of management for suspected cases of drug overdosage.

Recommended Actions In the event of an overdosage, it is essential to assess the patient's clinical status promptly. Supportive care should be initiated as necessary, and vital signs should be monitored closely. Healthcare providers should consider contacting a poison control center for guidance on the management of the specific substance involved.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for signs of toxicity that may arise from excessive dosing. Symptoms may vary depending on the pharmacological properties of the drug and the individual patient's response.

Management Procedures Management of overdosage typically involves symptomatic treatment and supportive care. This may include the administration of activated charcoal if the patient presents within a suitable timeframe and is deemed appropriate. Further interventions may be required based on the clinical presentation and the specific drug involved.

In summary, due to the lack of specific overdosage information, healthcare professionals should rely on established protocols for managing suspected overdosage cases, ensuring that patient safety remains the top priority.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

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 or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness, if symptoms do not improve within 7 days, or if these symptoms occur alongside a fever. It is important to emphasize that patients should not exceed the recommended dose while using this product.

Additionally, healthcare providers should encourage patients to consult with a doctor prior to 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 an NDC number for identification. It should be stored at a temperature range of 20-25 °C (68-77 °F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the seal under the cap is broken or missing, as this may compromise the integrity of the product. Proper handling and storage conditions are essential to maintain the quality and safety of the product.

Additional Clinical Information

No further data are available.

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.