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Valumeds Nasal Decongestant Phenylephrine Hcl

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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 2025
Label revision date
July 22, 2025
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 2025
Label revision date
July 22, 2025
Manufacturer
Cabinet Health P. B. C.
Registration number
M012
NDC root
82725-1111
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

This medication is designed to temporarily relieve sinus congestion and pressure, making it easier for you to breathe. It is also effective in alleviating nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. By targeting these symptoms, the drug helps you feel more comfortable during times of congestion.

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 common issues.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer choice for those concerned about such risks.

Dosage and Administration

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

For children under 12 years old, it's best to consult a doctor before giving them this medication. They can provide guidance on the appropriate dosage and ensure it's safe for your child's specific needs. Always follow these instructions carefully to use the medication effectively.

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 often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, you should not use this product for at least two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist before using this product.

While using this product, it’s important to stick to the recommended dose and not exceed it. This helps prevent potential misuse or abuse, which can lead to dependence (a condition where your body becomes reliant on a substance). Always prioritize your safety and well-being by following these guidelines.

Side Effects

If you experience nervousness, dizziness, or sleeplessness while using this medication, it's important to stop taking it and consult your doctor. Additionally, if your symptoms do not improve within 7 days or if you develop a fever, seek medical advice. You should not use this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks.

Before using this medication, talk to your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. In the event of an overdose, seek immediate medical help or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

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

Before using this medication, it's important to talk to your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. If you experience an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop taking this medication and call your doctor if you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within seven days or occur with a fever.

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 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 using this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. This ensures that the treatment is safe and appropriate for their specific needs. Always prioritize your child's health by seeking professional advice when it comes to medications.

Geriatric Use

If you are an older adult or caring for one, it's important to consult with a doctor before using this medication, especially if there are existing health concerns such as heart disease, high blood pressure, thyroid issues, diabetes, or difficulty urinating due to an enlarged prostate. These conditions can affect how the medication works in your body.

For adults and children aged 12 and older, the recommended dosage is one tablet every four hours, but you should not exceed six tablets in a 24-hour period. If the person is under 12 years old, please consult a doctor for appropriate guidance. Always prioritize safety and seek professional advice when it comes to medication use.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

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 (issues with liver function).

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 about combining medications. 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, you should not use this product. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist for clarification.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health is a priority, and your provider can help you navigate your treatment options effectively.

Storage and Handling

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

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period. If the patient is under 12 years old, it's important to consult a doctor for appropriate dosing guidance.

FAQ

What does this drug relieve?

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

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

Adults and children 12 years and over should take 1 tablet every 4 hours, not exceeding 6 tablets in 24 hours.

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

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

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned for this drug.

What should I do if I experience nervousness or dizziness?

You should stop using the drug and ask a doctor if you experience nervousness, dizziness, or sleeplessness.

Can I use this drug if I am taking a monoamine oxidase inhibitor (MAOI)?

No, you should not use this drug if you are currently taking a prescription MAOI or for 2 weeks after stopping the MAOI.

What should I do in case of overdose?

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

What precautions should I take before using this drug?

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

What should I do if my symptoms do not improve?

If your symptoms do not improve within 7 days or occur with a fever, stop using the drug and ask a doctor.

What is the storage requirement for this drug?

Store the drug between 20°–25°C (68°–77°F).

Packaging Info

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

Packaging configurations for Valumeds Nasal Decongestant Phenylephrine Hcl.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL Code 34089-3 and is packaged in a bottle. It is represented in a media type of image/jpeg.

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

Adults and children aged 12 years and over are advised to take 1 tablet every 4 hours as needed. The maximum recommended dosage is 6 tablets within a 24-hour period.

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

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

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

Warnings and Precautions

The 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 are advised to confirm with patients whether their prescription medications contain an MAOI prior to recommending this product.

Healthcare providers should exercise caution and advise patients to consult a physician before using this product if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

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

Patients should be instructed to 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 a fever, medical advice should be sought promptly.

Side Effects

Patients may experience a range of adverse reactions while using this medication. Serious adverse reactions warrant immediate medical attention, including symptoms such as nervousness, dizziness, or sleeplessness. Patients are advised to discontinue use and consult a healthcare professional if these symptoms occur, or if symptoms do not improve within 7 days or are accompanied by a fever.

It is contraindicated to use this medication in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are used for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should not use this medication for at least 2 weeks after discontinuing an MAOI.

Before initiating treatment, patients should seek medical advice if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

In the event of an overdose, it is critical to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

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, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Packaging configurations for Valumeds Nasal Decongestant Phenylephrine Hcl.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important for caregivers to seek medical advice to ensure the safety and appropriateness of treatment for this age group.

Geriatric Use

Elderly patients should consult a healthcare provider prior to use if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period. There are no specific dosage recommendations provided for children under 12 years; therefore, consultation with a healthcare provider is advised for this age group.

It is essential for healthcare providers to monitor geriatric patients closely, considering the potential for increased sensitivity to medications and the presence of comorbid conditions that may necessitate dosage adjustments or additional precautions.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 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 effectively. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and address any potential complications that may arise.

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 to mitigate any adverse effects associated with the overdose.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, no data has been provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. They should also refrain from using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to use.

It is important for healthcare providers to instruct 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 seven days or if they experience symptoms accompanied by a fever.

Patients must be reminded not to exceed the recommended dose while using this product. Furthermore, healthcare providers should recommend that patients consult a doctor before use if they have a history of 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20°–25°C (68°–77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours, with a maximum of six tablets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.

Drug Information (PDF)

This file contains official product information for Valumeds Nasal Decongestant Phenylephrine Hcl, 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 Valumeds Nasal Decongestant Phenylephrine Hcl, 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.