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Childrens Sudafed

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Active ingredient
Pseudoephedrine Hydrochloride 15 mg/5 mL
Other brand names
Drug class
alpha-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 8, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Pseudoephedrine Hydrochloride 15 mg/5 mL
Other brand names
Drug class
alpha-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 8, 2024
Manufacturer
Kenvue Brands LLC
Registration number
M012
NDC root
50580-536
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® is a children's oral solution containing pseudoephedrine HCl, which is a nasal decongestant. This non-drowsy liquid, available in a pleasant grape flavor, is designed to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. It also helps alleviate sinus congestion and pressure, promoting drainage in the nasal passages and sinuses.

This alcohol and sugar-free solution is formulated to provide relief from a stuffy nose and sinus pressure, making it easier for your child to breathe comfortably.

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 pressure and congestion in your sinuses, making it easier for you to breathe. Additionally, it promotes drainage in your nasal passages and sinuses, which can further alleviate discomfort.

You can rely on this medication to help you feel more comfortable when you're experiencing these symptoms.

Dosage and Administration

To determine the right dose for you or your child, refer to the dosage chart provided. If your child is between 4 to 5 years old, the recommended dose is 5 milliliters (mL), while children aged 6 to 11 years should take 10 mL. It's important to note that if your child is under 4 years old, this medication should not be used.

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

What to Avoid

You should avoid using this product if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications often prescribed for depression, certain psychiatric conditions, or Parkinson's disease. It's also important not to use this product for at least two weeks after stopping an MAOI. If you're unsure whether your child's medication includes an MAOI, please consult a doctor or pharmacist before administering this product.

Additionally, be sure to follow the recommended dosage carefully. Exceeding the recommended dose can lead to serious issues, including potential misuse or dependence (a condition where the body becomes reliant on a substance). Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

Side Effects

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

It's crucial to avoid using this product if your child is taking a monoamine oxidase inhibitor (MAOI) or has certain health conditions, such as heart disease, high blood pressure, thyroid disease, or diabetes. Always follow the recommended dosage and keep the product out of reach of children. In case of an overdose, contact a medical professional or Poison Control Center immediately at 1-800-222-1222.

Warnings and Precautions

You should not give this product to a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has taken one in the past two weeks. MAOIs are specific medications used for depression, certain psychiatric conditions, or Parkinson's disease. If you're unsure whether your child's medication includes an MAOI, please consult a doctor or pharmacist before use.

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, or diabetes. 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.

Keep this product out of reach of children. 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 health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Children's Sudafed Nasal Decongestant (which contains pseudoephedrine hydrochloride) during pregnancy. The product insert does not mention any risks or contraindications associated with its use while pregnant, nor does it provide any dosage modifications for pregnant individuals.

While there are no special precautions outlined, it's always best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

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. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to be cautious when considering this medication for your child. You should not give it to a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks. Before using this medication, consult your doctor if your child has any heart conditions, high blood pressure, thyroid issues, or diabetes.

For dosing, this medication is not recommended for children under 4 years old. For children aged 4 to 5 years, the appropriate dose is 5 mL, while children aged 6 to 11 years can take 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 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 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 should be used if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be cautious when giving medications to children, especially if they are taking certain prescription drugs. For instance, you should not use this medication in a child who is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, 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 child's prescription includes an MAOI, it's best to consult with a doctor or pharmacist before proceeding.

Always discuss any medications or treatments with your healthcare provider to ensure safety and avoid potential interactions. Your provider can help you understand the risks and make informed decisions about your child's health.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its quality and performance. Before using the product, always check that the bottle wrap and the foil inner seal marked "SAFETY SEAL®" are intact. If either of these seals is broken or missing, do not use the product, as this could indicate contamination or compromise its safety.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

You should take this medication orally, repeating the dose every 4 to 6 hours as needed. However, be careful not to exceed 4 doses within a 24-hour period to ensure your safety. If you have any questions or concerns about how to use this medication, it's always a good idea to consult with your healthcare provider.

FAQ

What is SUDAFED®?

SUDAFED® is a children's pseudoephedrine HCl oral solution that acts as a nasal decongestant. It is non-drowsy, comes in a grape flavor liquid, and is alcohol and sugar-free.

What does SUDAFED® relieve?

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

What is the recommended dosage for 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®?

You can repeat the dose every 4 to 6 hours, but do not use more than 4 times in 24 hours.

Are there any contraindications for using SUDAFED®?

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

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® safe to use during pregnancy?

The provided information does not specify any risks or contraindications for using SUDAFED® during pregnancy.

Can nursing mothers use SUDAFED®?

There are no specific warnings or recommendations regarding the use of SUDAFED® in nursing mothers.

How should I store SUDAFED®?

Store SUDAFED® between 20-25°C (68-77°F) and do not use if the bottle wrap or foil inner seal is broken or missing.

Packaging Info

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

Packaging configurations for Childrens Sudafed.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Children's SUDAFED® is a non-drowsy nasal decongestant formulated as a pseudoephedrine HCl oral solution. It is indicated for the relief of nasal congestion and sinus pressure. The product is presented in a grape-flavored liquid form, containing 15 mg of pseudoephedrine HCl per 5 mL. It is alcohol and sugar-free, with a total volume of 4 fl oz (118 mL). The National Drug Code (NDC) for this formulation is 50580-536-04.

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 also provides temporary relief of sinus congestion and pressure, and promotes nasal and/or sinus drainage.

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 and should not be used. For children aged 4 to 5 years, the recommended dose is 5 mL. For those aged 6 to 11 years, the recommended dose is 10 mL.

Doses may be repeated every 4 to 6 hours as needed; however, it is imperative not to exceed 4 doses within a 24-hour period.

Administration should be performed using the enclosed dosing cup specifically designed for this product. The use of any other dosing device is not recommended.

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, and Parkinson's disease. Prior to administration, it is essential to confirm with a healthcare professional whether the child's prescription includes an MAOI.

Additionally, the recommended dosage should not be exceeded 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 caregivers to seek medical guidance before using this product if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, or diabetes. These underlying health issues may necessitate additional monitoring or alternative treatment options.

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

Caregivers should be instructed to discontinue use and consult a healthcare provider if the child experiences nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by a fever, medical advice should be sought.

To ensure safety, this product must be kept out of reach of children. In the event of an overdose, immediate medical assistance should be obtained, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in children who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. It is crucial to consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in the child's prescription.

Common adverse reactions that may arise during the use of this product include nervousness, dizziness, and sleeplessness. If any of these symptoms occur, it is advised to discontinue use and seek medical advice. Additionally, if symptoms do not improve within seven days or are accompanied by a fever, medical consultation is recommended.

Patients with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, or diabetes should consult a doctor before using this product. It is essential to adhere to the recommended dosage to avoid potential complications. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. This product should be kept out of reach of children to prevent accidental ingestion.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated in pediatric patients. MAOIs are typically prescribed for the treatment of depression, certain psychiatric or emotional conditions, and Parkinson's disease. Administration of this product in conjunction with an MAOI, or within 2 weeks of discontinuing an MAOI, may lead to serious adverse effects.

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

Packaging & NDC

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

Packaging configurations for Childrens Sudafed.
Details

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For those aged 4 to 5 years, the recommended dose is 5 mL, while patients aged 6 to 11 years may receive 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 medication to children with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, or diabetes. Additionally, this medication 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.

Pregnancy

There is no specific information available regarding the use of Children's Sudafed Nasal Decongestant (pseudoephedrine hydrochloride) during pregnancy. The prescribing information does not indicate any contraindications or risks associated with the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are specified. Furthermore, the text does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing 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 are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation.

Prompt intervention is crucial in mitigating potential adverse effects associated with an overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and effective recovery.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. These events have been documented in the context of routine pharmacovigilance activities.

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 medication. Patients should be encouraged to consult with a doctor or pharmacist if they are uncertain whether their child's prescription includes an MAOI.

Patients should be made aware that they must stop using the product and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by a fever, they should seek medical advice.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and not exceeding it while using this product. Furthermore, 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, or diabetes.

Storage and Handling

The product is supplied in a configuration that includes a bottle with a safety seal. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Healthcare professionals should ensure that the bottle wrap and the foil inner seal, which is imprinted with "SAFETY SEAL®," are intact before use. If either of these seals is broken or missing, the product should not be used. Proper handling and storage conditions are crucial to ensure the product's safety and effectiveness.

Additional Clinical Information

The medication is administered orally, with a recommended repeat dosing interval of every 4 to 6 hours. Clinicians should advise patients not to exceed four 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, 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, 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.