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Zephrex D

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Active ingredient
Pseudoephedrine Hydrochloride 30 mg
Other brand names
Drug class
alpha-Adrenergic Agonist
Dosage form
Capsule, Gelatin 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 2016
Label revision date
November 11, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Pseudoephedrine Hydrochloride 30 mg
Other brand names
Drug class
alpha-Adrenergic Agonist
Dosage form
Capsule, Gelatin 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 2016
Label revision date
November 11, 2024
Manufacturer
L. Perrigo Company
Registration number
M012
NDC root
0113-0401
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

ZEPHREX-D is a nasal decongestant designed to provide fast relief from nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. Each softgel contains 30 mg of pseudoephedrine HCl, which works by temporarily relieving nasal and sinus congestion and pressure. This non-drowsy formula is easy to take and begins to work in as little as 30 minutes, making it a convenient option for those seeking quick relief.

In addition to its effectiveness, ZEPHREX-D features advanced meth-blocking technology, aimed at promoting safer communities. The product comes in a package of 24 individually sealed softgels, ensuring freshness and ease of use.

Uses

If you're dealing with a stuffy nose from a common cold, hay fever, or other upper respiratory allergies, this medication can help. It works by temporarily relieving nasal congestion, making it easier for you to breathe.

Additionally, if you're experiencing sinus congestion and pressure, this medication can provide temporary relief, helping to ease discomfort in your sinuses.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 2 softgels every 4 to 6 hours as needed. However, make sure not to exceed 8 softgels in a 24-hour period to avoid any potential side effects.

For children between the ages of 6 and under 12 years, the recommended dosage is 1 softgel every 4 to 6 hours. Just like with adults, it’s important not to give them more than 4 softgels in a 24-hour period. Please note that this product is not suitable for children under 6 years of age, so do not use it for that age group. Always follow these guidelines to ensure safe and effective use.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric 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.

While using this product, it’s important to adhere strictly to the recommended dosage. Exceeding this dosage can lead to serious health risks, including potential misuse or 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 and consult your doctor. Additionally, if your symptoms do not improve within 7 days or if you develop a fever, seek medical advice.

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. Also, do not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. If you're unsure whether your medication contains an MAOI, please ask your doctor or pharmacist.

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 or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist before using this product.

Before starting 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. Additionally, stop taking the medication and call your doctor if you feel nervous, dizzy, or unable to sleep, 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 take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is 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

When it comes to using this medication for children, there are specific guidelines to follow. For children aged 6 to under 12 years, you can give them 1 softgel every 4 to 6 hours, but make sure they do not take more than 4 softgels in a 24-hour period.

However, it's important to note that this product should not be used in children under 6 years of age. Always consult with your child's healthcare provider if you have any questions or concerns about their medication.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize safety and open communication with your medical team.

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 determine the best course of action based on your kidney function and overall 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).

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 drug interactions when considering any new 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, 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 and well-being are the top priority, so don't hesitate to ask questions about your treatments.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness. Before using, always check the blister unit; do not use it if it is broken or torn, as this could compromise the product's safety and effectiveness.

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. For adults, the recommended dosage is 2 softgels every 4 to 6 hours, but do not exceed 8 softgels in a 24-hour period. If you are using a lower dosage, take 1 softgel every 4 to 6 hours, with a maximum of 4 softgels in 24 hours. Always follow these guidelines to ensure safe and effective use of the medication.

FAQ

What is ZEPHREX-D?

ZEPHREX-D is a nasal decongestant in a new dosage form, containing 30 mg of pseudoephedrine HCl, designed to relieve nasal and sinus congestion.

How does ZEPHREX-D work?

It temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies, and also alleviates sinus congestion and pressure.

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

Adults and children 12 years and over should take 2 softgels every 4 to 6 hours, not exceeding 8 softgels in 24 hours.

What is the dosage for children aged 6 to under 12?

Children ages 6 to under 12 years should take 1 softgel every 4 to 6 hours, with a maximum of 4 softgels in 24 hours.

Is ZEPHREX-D safe for children under 6?

No, ZEPHREX-D should not be used in children under 6 years of age.

What should I do if I experience side effects?

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

Are there any warnings for using ZEPHREX-D?

Do not use ZEPHREX-D if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor or pharmacist if unsure.

What should I do in case of an overdose?

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

Can I use ZEPHREX-D if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using ZEPHREX-D.

How should I store ZEPHREX-D?

Store ZEPHREX-D at 20-25°C (68-77°F) and do not use if the blister unit is broken or torn.

Packaging Info

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

Packaging configurations for Zephrex D.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Pseudoephedrine HCl 30 mg is a nasal decongestant formulated to relieve nasal and sinus congestion as well as sinus pressure. This product incorporates METH BLOCKING TAREX® TECHNOLOGY™, designed to enhance safety within communities. The formulation is presented in an easy-to-take softgel dosage form, with each softgel individually sealed to ensure integrity. The fast-acting properties of this decongestant allow it to begin working in as little as 30 minutes. Each package contains 24 softgels, and the product is characterized as non-drowsy, making it suitable for use throughout the day.

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 of sinus congestion and pressure.

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 softgels every 4 to 6 hours as needed. The maximum allowable dosage is 8 softgels within a 24-hour period.

For children aged 6 to under 12 years, the recommended dosage is 1 softgel every 4 to 6 hours. The total dosage should not exceed 4 softgels in a 24-hour period.

This product is not recommended for use in children under 6 years of age.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should consult a healthcare professional if uncertain whether their prescription includes an MAOI.

Additionally, exceeding the recommended dosage while using this product is 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 consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in a patient's prescription medication.

General precautions should be observed prior to use. Patients should be advised to seek medical consultation if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. These conditions may increase the risk of adverse effects and warrant careful consideration before initiating treatment.

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 provider 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 product. Serious reactions warrant immediate medical attention, including 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 a fever, medical advice should be sought.

Certain pre-existing conditions may increase the risk of adverse reactions. Patients should consult a doctor before using this product if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.

It is crucial for patients to avoid using this product concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should refrain from using this product for at least 2 weeks after discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in their prescription medication, patients should seek clarification from a healthcare provider or pharmacist prior to use.

Drug Interactions

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

Packaging configurations for Zephrex D.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may take 1 softgel every 4 to 6 hours, with a maximum of 4 softgels in a 24-hour period. The product is not recommended for use in children under 6 years of age.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 drug 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 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 effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms as they 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 address any complications that may develop during the course of treatment.

Nonclinical Toxicology

If pregnant or breastfeeding, 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

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, and sleeplessness. Additionally, cardiovascular-related events such as heart disease and high blood pressure have been noted. Endocrine and metabolic disorders, including thyroid disease and diabetes, were also reported. Furthermore, instances of urinary difficulties due to an enlarged prostate gland have been documented.

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. 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 doctor 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 a fever.

It is important to emphasize to patients the necessity of adhering to the recommended dosage and not exceeding it. Healthcare providers should also recommend that patients consult a doctor prior to use 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.

Storage and Handling

The product is supplied in a blister pack configuration. It should be stored at a temperature range of 20-25°C (68-77°F). Healthcare professionals are advised to inspect the blister unit prior to use; the product should not be utilized if the blister unit is broken or torn. Proper handling and storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally. Patients are advised to take 2 softgels every 4 to 6 hours, with a maximum of 8 softgels in a 24-hour period. Alternatively, patients may take 1 softgel every 4 to 6 hours, not exceeding 4 softgels in 24 hours.

No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Zephrex D, 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 Zephrex D, 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.