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Nasal and Sinus Decongestant

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Active ingredient
Phenylephrine Hydrochloride 5 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 2000
Label revision date
April 26, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 5 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 2000
Label revision date
April 26, 2024
Manufacturer
JHK Inc dba American Safety & First Aid
Registration number
M012
NDC roots
73598-1262, 73598-1264
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 is a nasal and sinus decongestant that helps reduce congestion and pressure in your nasal passages. It works by temporarily relieving nasal congestion caused by conditions such as the common cold, hay fever, or other upper respiratory allergies, allowing you to breathe more freely through your nose.

This medication is available in convenient tablet form, making it easy to use when you need relief from nasal discomfort.

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 works by reducing congestion and pressure in your nasal passages and sinuses, helping you breathe more freely through your nose.

You can expect this treatment to help alleviate the discomfort associated with these conditions, making it easier for you to go about your day.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 2 tablets every 4 to 6 hours as needed. However, make sure not to exceed 8 tablets in a 24-hour period unless your doctor advises otherwise.

For children under 12 years of age, it’s important to consult a doctor before giving them this medication. Always follow your healthcare provider's instructions to ensure safe and effective use.

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, it's important to consult your doctor or pharmacist before using this product.

While using this product, make sure not to exceed the recommended dose, as doing so can lead to misuse or potential dependence (a condition where your body becomes reliant on a substance). Always prioritize your safety and well-being by following these guidelines closely.

Side Effects

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

Before using this medication, talk to your doctor if you have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. Also, avoid this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. If you're unsure whether your prescription includes an MAOI, check with 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 or certain other conditions. Additionally, 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.

Before using this product, it's important to ask your doctor if you have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. Always follow the recommended dosage and do not exceed it. 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.

Keep this product out of reach of children. In case of an overdose, seek medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you would typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety and health. Always keep emergency contact information handy, and remember that it’s better to be safe and get checked out if you have any concerns about an overdose.

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 this medication for your child, it's important to consult with a doctor if your child is under 12 years old. For children aged 12 and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed, but be sure not to exceed 8 tablets in a 24-hour period unless directed by a healthcare professional. Always follow your doctor's advice regarding the use of this medication in children.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver disease, it’s important to consult your doctor before using this medication. Your healthcare provider can help determine if it’s safe for you and whether any adjustments to your dosage are necessary. Monitoring your liver function may also be required to ensure your safety while using this treatment. Always prioritize open communication with your healthcare team regarding your liver 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 prescription 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 about your medications.

Storage and Handling

To ensure the safety and effectiveness of your product, always store it at room temperature, ideally between 59°F and 86°F (15°C and 30°C). It's important to keep it away from excessive heat and humidity, as these conditions can affect its quality.

Before use, check the packet carefully; do not use it if the packet is opened or torn, as this could compromise the product's integrity. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should take 2 tablets every 4 to 6 hours as needed if you are an adult or a child aged 12 years and older. However, do not exceed 8 tablets in a 24-hour period unless directed by your doctor. If you are caring for a child under 12, consult a doctor for the appropriate dosage.

If you are pregnant or breastfeeding, it's important to ask a health professional before using this medication. Always keep it out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately.

FAQ

What is Phenylephrine used for?

Phenylephrine is a nasal and sinus decongestant that temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies.

How does Phenylephrine work?

It helps reduce nasal and sinus congestion and pressure, restoring free breathing through the nose.

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

Adults and children 12 years of age and older should take 2 tablets every 4 to 6 hours as needed, not exceeding 8 tablets in 24 hours.

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

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

Are there any contraindications for using Phenylephrine?

Do not use Phenylephrine if you are taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one in the last 2 weeks.

What should I do if I experience side effects?

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

Can I use Phenylephrine if I am pregnant or breastfeeding?

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

How should I store Phenylephrine?

Store Phenylephrine at room temperature, between 59° - 86°F (15° - 30°C), and avoid excessive heat and humidity.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

Packaging Info

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

Packaging configurations for Nasal and Sinus Decongestant.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Product #1262 is a nasal and sinus decongestant formulated to alleviate nasal and sinus congestion and pressure, thereby restoring free breathing through the nose. The active ingredient is phenylephrine. This product is presented in the form of quality comfort tablets, packaged specifically for workplace use, and complies with ANSI Z308.1-2015 standards. Each tablet is sealed in tamper-evident packets for enhanced safety and convenience. The product contains 100 tablets, with 2 tablets per packet.

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. It aids in reducing nasal and sinus congestion and pressure, facilitating the restoration of free breathing through the nose.

Limitations of Use: 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 2 tablets every 4 to 6 hours as needed. The total daily dosage should not exceed 8 tablets within a 24-hour period, unless otherwise directed by a healthcare professional.

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

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 a period of 2 weeks following the discontinuation of an MAOI. Patients uncertain about whether their prescription includes an MAOI should consult a healthcare professional prior to use.

Exceeding the recommended dose while using this product is also contraindicated.

Warnings and Precautions

Use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Prior to using this product, patients should seek medical advice if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. These conditions may necessitate closer monitoring or alternative treatment options.

While using this product, it is imperative that patients do not exceed the recommended dosage. Exceeding this dosage may lead to adverse effects.

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

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be obtained, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients may experience a range of adverse reactions while using this product. 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, or if new symptoms arise, patients should seek medical advice.

Common adverse reactions may include those related to pre-existing conditions. Patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing trouble urinating due to an enlarged prostate gland should consult a healthcare provider before using this product.

Warnings are in place regarding the concurrent use of this product with prescription monoamine oxidase inhibitors (MAOIs). Patients should not use this product if they are currently taking an MAOI or have stopped taking one within the past two weeks. If patients are uncertain whether their prescription medication contains an MAOI, they should consult a doctor or pharmacist prior to 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 an MAOI or for a period 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.

Packaging & NDC

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

Packaging configurations for Nasal and Sinus Decongestant.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 4 to 6 hours as needed, with a maximum of 8 tablets in a 24-hour period, unless otherwise directed by a healthcare provider.

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 healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance regarding the use of this product, as compromised liver function may affect the metabolism and clearance of the medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this patient population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

Nonclinical Toxicology

If pregnant or breastfeeding, individuals are advised to consult a health professional prior to use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

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.

Patients should be informed that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should consult their doctor or pharmacist prior to using this product.

Healthcare providers should counsel patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop using the product and seek medical advice if their symptoms do not improve within 7 days or if they are accompanied by fever. Patients should also be instructed to stop use and consult a doctor if new symptoms arise.

It is important to remind patients not to exceed the recommended dose while using this product. Furthermore, healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, 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 packets that must not be used if the packet is opened or torn. It should be stored at room temperature, specifically within the range of 59° to 86°F (15° to 30°C). Care should be taken to avoid exposure to excessive heat and humidity to maintain product integrity.

Additional Clinical Information

Adults and children aged 12 years and older are advised to take 2 tablets every 4 to 6 hours as needed, with a maximum of 8 tablets in a 24-hour period, unless otherwise directed by a healthcare professional. 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. It is important to keep the medication out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Nasal and Sinus Decongestant, 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 and Sinus Decongestant, 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.