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Su Phedrine Pe

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Active ingredient
Phenylephrine Hydrochloride 10 mg
Other brand names
Drug class
alpha-1 Adrenergic Agonist
Dosage form
Tablet, Film Coated
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
January 15, 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, Film Coated
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
January 15, 2025
Manufacturer
Salado Sales, Inc.
Registration number
M012
NDC root
57243-953
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

CVP® is a nasal decongestant that contains the active ingredient phenylephrine hydrochloride (SU•PHEDRINE PE). It is designed to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies, as well as to alleviate sinus congestion and pressure. This medication is non-drowsy and comes in a maximum strength formulation, with each tablet containing 10 mg of the active ingredient.

You can take CVP® as needed, with a recommended dose of one pill at a time. It is important to note that this product does not contain pseudoephedrine, a common ingredient found in other decongestants. If you're looking for relief from nasal and sinus congestion, CVP® may be a suitable option for you.

Uses

You can use this medication to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. If you're feeling pressure and congestion in your sinuses, this medication can also help alleviate those symptoms.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

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

For children under 12 years old, it’s important to consult a doctor before giving them this medication. This ensures that they receive the appropriate care and dosage tailored to their specific needs. Always follow these guidelines to use the medication safely and 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 used for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, do not use it 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.

It's also important to follow the recommended dosage and not exceed it. Taking more than the advised amount can lead to serious health risks. Always prioritize your safety and well-being by adhering to these guidelines.

Side Effects

If you experience nervousness, dizziness, or sleeplessness while using this medication, it's important to stop using 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), which is a type of medication used for depression, psychiatric conditions, or Parkinson’s disease, or for two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, please check with your doctor or pharmacist before using this product.

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

Before using this product, it’s important to talk to your doctor if you have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland. If you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within seven days or occur with a fever, stop using the product and contact your doctor. In the event of an overdose, seek emergency 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. Always keep emergency contact information handy and be aware of the signs that indicate you need urgent assistance. Your health is important, so don’t hesitate to reach out for help if you think you’ve taken too much of a medication.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child under 12 years old, it's important to consult with a doctor before giving them this medication. For children aged 12 and older, the recommended dosage is one tablet every four hours, but be sure not to exceed six tablets in a 24-hour period. Always follow these guidelines to ensure the safety and well-being of your child.

Geriatric Use

If you are an older adult or caring for one, it's important to consult a doctor before using this medication, especially if you have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or trouble urinating due to an enlarged prostate. These health issues can affect how the medication works in your body and may require special attention or adjustments to your treatment plan. Always prioritize safety and communicate openly with your healthcare provider about your health history and any concerns you may have.

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 (liver issues).

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

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, certain 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 make informed decisions about your treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally around 25°C (77°F). It’s acceptable for the temperature to vary between 15°C and 30°C (59°F to 86°F). Always check the end flap for the expiration date and lot number to confirm its validity.

When handling the product, be cautious: do not use it if the outer package is opened or if the blister is torn or broken, as this indicates it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose 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, consult a doctor for appropriate dosing.

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

FAQ

What is CVP® used for?

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

What is the active ingredient in CVP®?

The active ingredient in CVP® is SU•PHEDRINE PE (Phenylephrine Hydrochloride).

How should I take CVP®?

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

Are there any contraindications for using CVP®?

Do not use CVP® if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if I experience side effects?

Stop using CVP® and ask a doctor if you experience nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days or occur with fever.

Is CVP® safe to use during pregnancy or breastfeeding?

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

What precautions should I take before using CVP®?

Ask a doctor before use if you have heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to prostate enlargement.

How should I store CVP®?

Store CVP® at 25°C (77°F), with permitted excursions between 15°-30°C (59°-86°F).

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Su Phedrine Pe.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

CVP® HEALTH is a nasal decongestant formulated with 10 mg of phenylephrine hydrochloride as the active ingredient. The product is presented in the form of tablets, with a total quantity of 18 tablets per package. Each dose consists of one tablet, and the formulation is designed to be non-drowsy and free from pseudoephedrine. The product features tamper-evident packaging, and it should not be used if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. This product is distributed by Consumer Value Products, Inc., located at P.O. Box 6115, Temple, Texas 76502, and is not manufactured or distributed by Johnson & Johnson Corporation, the owner of the registered trademark SUDAFED PE® SINUS CONGESTION.

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

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) for depression, psychiatric or emotional conditions, or Parkinson’s disease, and for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI. Additionally, exceeding the recommended dosage is contraindicated.

Warnings and Precautions

It is imperative that this product not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, the product should not be taken for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their current prescription medications.

Before initiating treatment, it is essential for patients to seek medical advice if they have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to prostate gland enlargement. These conditions may necessitate closer monitoring or alternative therapeutic strategies.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Patients are advised to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not show improvement within seven days or are accompanied by fever, medical consultation is warranted.

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. If these symptoms occur, patients are advised to stop use and consult a healthcare professional. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, medical advice should be sought.

It is important to note that this product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients must refrain from using this product while taking an MAOI and for at least 2 weeks after discontinuing the MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should consult a doctor or pharmacist prior to using this product.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson’s disease. Patients should not take this product while on MAOIs or for a 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, 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 Su Phedrine Pe (phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Su Phedrine Pe.
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 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this medication if they have a history of heart disease, diabetes, thyroid disease, high blood pressure, or experience difficulty in urination due to prostate gland enlargement. These conditions may necessitate careful monitoring and potential dosage adjustments to ensure safety and efficacy in this population. It is essential for healthcare providers to evaluate the overall health status and comorbidities of geriatric patients to mitigate risks associated with the use of this medication.

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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to ensure appropriate interventions are implemented in a timely manner.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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 in the event of an overdose. It is crucial to inform patients that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should also be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult with their doctor or pharmacist.

Patients should be instructed to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, they 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 fever.

It is important to emphasize to patients the necessity of adhering to the recommended dosage and not exceeding it while using this product. Healthcare providers should also recommend that patients consult a doctor prior to use if they have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in tamper-evident packaging. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). For reference, the expiration date and lot number can be found on the end flap of the packaging.

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, it is advised to consult a doctor regarding appropriate dosing.

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. 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 Su Phedrine 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 Su Phedrine Pe, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.