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Childrens Sudafed Pe

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Active ingredient
Phenylephrine Hydrochloride 2.5 mg/5 mL
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2008
Label revision date
November 4, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Phenylephrine Hydrochloride 2.5 mg/5 mL
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Solution
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 2008
Label revision date
November 4, 2024
Manufacturer
Kenvue Brands LLC
Registration number
M012
NDC root
50580-784
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

SUDAFED PE is a non-drowsy nasal decongestant designed to help relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. It comes in a berry-flavored liquid form, making it easier to take, especially for children. This medication works by temporarily relieving stuffy noses and sinus pressure, helping you feel more comfortable when you're dealing with congestion.

The formulation contains phenylephrine HCl, which is effective in reducing swelling in the nasal passages, allowing for easier breathing. SUDAFED PE is also alcohol and sugar-free, making it a suitable option for those who prefer to avoid these ingredients.

Uses

If you're dealing with nasal congestion from a 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, giving you a sense of comfort and relief. Remember, these effects are temporary, so it's important to follow the recommended guidelines for use.

Dosage and Administration

To determine the right dose of your medication, refer to the dosage chart provided with the product. If you are giving this medication to a child, it's important to note that children under 4 years old should not use it. For children aged 4 to 5 years, the recommended dose is 5 milliliters (mL), while children aged 6 to 11 years should take 10 mL.

Make sure to use the dosing cup that comes with the product, as it is specifically designed for accurate measurement. You should repeat the dose every 4 hours, but remember not to exceed 6 doses in a 24-hour period to ensure safety.

What to Avoid

It's important to be cautious when using this product. You should not give it to a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications often 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.

Always follow the recommended dosage and never exceed it. Misusing or taking more than directed can lead to serious issues, including dependence (a condition where your body becomes reliant on a substance). If you have any questions about your child's medications, consult a doctor or pharmacist for guidance.

Side Effects

If you notice nervousness, dizziness, or sleeplessness in your child while using this medication, it's important to stop use and consult a doctor. Additionally, if symptoms do not improve within 7 days or if they occur alongside a fever, seek medical advice.

Before using this medication, talk to a doctor if your child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or is on a sodium-restricted diet. Also, do not give this medication to a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks. If you're unsure whether your child's medication includes an MAOI, please consult a doctor or pharmacist.

Warnings and Precautions

You should not give this product to a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping an MAOI. These medications are often used for depression, certain psychiatric conditions, or Parkinson's disease. If you're unsure whether your child's medication contains an MAOI, please consult a doctor or pharmacist.

Before using this product, it's important to check with a doctor if your child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or is on a sodium-restricted diet. Always follow the recommended dosage and do not exceed it. If your child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within seven days or occur with a fever, stop using the product and contact a doctor.

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

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or warnings about using Children's Sudafed PE Nasal Decongestant (phenylephrine hydrochloride) during pregnancy. The information available does not indicate any safety concerns, contraindications (situations where the product should not be used), or special precautions related to its use while pregnant.

However, since there is limited information, it's always a good idea to consult with your healthcare provider before using any medication during pregnancy. They can help you weigh the benefits and risks based on your individual health needs.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding. Your health and the well-being of your baby are important, and your provider can help guide you in making the best choices.

Pediatric Use

It's important to be cautious when considering this medication for your child. Do not give it to children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one in the past two weeks. Before using this medication, consult your doctor if your child has any heart issues, high blood pressure, thyroid problems, diabetes, or is on a sodium-restricted diet.

For dosing, children under 4 years old should not use this medication at all. For those aged 4 to 5 years, the recommended dose is 5 mL, and for children aged 6 to 11 years, the dose increases to 10 mL. Always use the dosing cup that comes with the product, as other measuring devices may not provide the correct amount.

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 for personalized advice. 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 problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's crucial to be aware of potential interactions when considering medications for yourself or your child. For instance, if your child is taking a prescription monoamine oxidase inhibitor (MAOI)—a type of medication often used for depression or certain psychiatric conditions—you should avoid using this product. This includes a two-week period after stopping the MAOI. If you're unsure whether your child's medication includes an MAOI, it's important to consult with a doctor or pharmacist before proceeding.

Always discuss any medications or tests with your healthcare provider to ensure safety and effectiveness. They can help you navigate potential interactions and make informed decisions about treatment options.

Storage and Handling

To ensure the safety and effectiveness 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 the product protected from light, so make sure to keep it in the outer carton until you are ready to use it.

Before using, check that the carton tape or bottle wrap marked "Sealed For Your Safety" is intact. If it is broken or missing, do not use the product, as this could indicate that it has been compromised. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should take this medication orally, repeating the dose every 4 hours as needed. However, be careful not to exceed 6 doses within a 24-hour period to ensure your safety and avoid potential side effects. If you have any questions about how to use this medication, consult your healthcare provider for guidance.

FAQ

What is SUDAFED PE?

SUDAFED PE is a non-drowsy nasal decongestant that temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies.

What is the recommended dosage for children?

For children aged 4 to 5 years, the dosage is 5 mL, and for those aged 6 to 11 years, it is 10 mL. Do not use in children under 4 years.

How often can I give SUDAFED PE to my child?

You can repeat the dose every 4 hours, but do not exceed 6 doses in 24 hours.

Are there any contraindications for using SUDAFED PE?

Do not use SUDAFED PE in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI.

What should I do if my child experiences side effects?

Stop use and ask a doctor if your child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days or occur with a fever.

Is SUDAFED PE safe to use during pregnancy?

There are no specific statements regarding the use of SUDAFED PE during pregnancy in the provided information.

How should I store SUDAFED PE?

Store SUDAFED PE between 20-25°C (68-77°F), protect it from light, and keep it in the outer carton until used.

Packaging Info

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

Packaging configurations for Childrens Sudafed Pe.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NDC 50580-784-04. Children's SUDAFED® PE is a non-drowsy nasal decongestant formulated as a phenylephrine HCl oral solution. This product is designed to provide relief from symptoms associated with nasal congestion, including stuffy nose and sinus pressure. The solution is presented in a berry-flavored liquid form, is alcohol and sugar-free, and is available in a 4 fl oz (118 mL) bottle, delivering 2.5 mg of phenylephrine HCl per 5 mL.

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

Healthcare professionals should determine the appropriate dosage based on the patient's age, as outlined below.

For patients under 4 years of age, the product is contraindicated. For those aged 4 to 5 years, the recommended dose is 5 mL. For patients aged 6 to 11 years, the recommended dose is 10 mL.

Doses should be administered every 4 hours as needed, with a maximum of 6 doses within a 24-hour period. It is essential to use only the enclosed dosing cup specifically designed for this product; no other dosing devices should be utilized to ensure accurate measurement and administration.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Prior to administration, healthcare professionals should verify whether the child's prescription includes an MAOI.

Additionally, it is contraindicated to exceed the recommended dosage while using this product.

Warnings and Precautions

The use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to administration.

Healthcare professionals should advise parents or guardians to seek medical guidance before using this product if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or is on a sodium-restricted diet.

It is crucial to adhere to the recommended dosage when using this product. Exceeding the recommended dose may lead to adverse effects.

Should the child experience nervousness, dizziness, or sleeplessness, or if symptoms do not improve within seven days or are accompanied by a fever, it is essential to discontinue use and consult a healthcare provider.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Side Effects

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

Common adverse reactions may arise in patients with pre-existing conditions. It is advised that patients consult a doctor prior to use if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or are on a sodium-restricted diet.

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 there is uncertainty regarding the presence of an MAOI in a patient's prescription medication, it is essential to consult a healthcare provider or pharmacist before administration.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated. This includes patients who are currently taking prescription MAOIs for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be administered for a period of two weeks following the discontinuation of an MAOI.

Healthcare professionals are advised to confirm whether a patient's prescription includes an MAOI prior to the administration of this product. If there is any uncertainty regarding the presence of an MAOI in the patient's medication regimen, consultation with a doctor or pharmacist is recommended to ensure patient safety.

Packaging & NDC

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

Packaging configurations for Childrens Sudafed Pe.
Details

Pediatric Use

Pediatric patients under 4 years of age should not use this product. For those aged 4 to 5 years, the recommended dose is 5 mL, while patients aged 6 to 11 years may receive a dose of 10 mL. It is crucial to use only the enclosed dosing cup specifically designed for this product; other dosing devices should not be used.

Healthcare professionals should exercise caution and consult a physician before administering this product to children with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or those on a sodium-restricted diet. Additionally, this product must not be used in any child currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI.

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

There are no specific statements regarding the use of Children's Sudafed PE Nasal Decongestant (phenylephrine hydrochloride) during pregnancy. The available prescribing information does not indicate any safety concerns, contraindications, or special precautions associated with the use of this product in pregnant patients. As such, healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this medication during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function. Regular monitoring of renal function may be warranted in these patients, although specific guidelines are not outlined.

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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential to determine the appropriate course of action.

Management procedures may include supportive care, symptomatic treatment, and, if applicable, the administration of specific antidotes. Continuous evaluation of the patient's condition is necessary to ensure effective management and to mitigate potential complications arising from the overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep this medication 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.

It is crucial to inform patients that this medication should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such a medication. Patients should be encouraged to consult with their doctor or pharmacist if they are uncertain whether their child's prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness, or if symptoms do not improve within seven days or are accompanied by a fever.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and not exceeding it while using this product. Additionally, patients should be advised to consult a doctor before use if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or is on a sodium-restricted diet.

Storage and Handling

The product is supplied in packaging that must be stored between 20-25°C (68-77°F). It is essential to protect the product from light and to keep it in the outer carton until the contents are needed for use. Healthcare professionals should ensure that the carton tape or bottle wrap imprinted with "Sealed For Your Safety" is intact; the product should not be used if this seal is broken or missing.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dose every 4 hours. Clinicians should advise patients not to exceed 6 doses within a 24-hour period to ensure safety and efficacy.

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

Drug Information (PDF)

This file contains official product information for Childrens Sudafed 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 Childrens Sudafed 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.

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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.