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Pseudoephedrine hydrochloride

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Active ingredient
Pseudoephedrine Hydrochloride 30 mg
Other brand names
Drug class
alpha-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 2019
Label revision date
February 5, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Pseudoephedrine Hydrochloride 30 mg
Other brand names
Drug class
alpha-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 2019
Label revision date
February 5, 2026
Manufacturer
Major Pharmaceuticals
Registration number
M012
NDC root
0904-6990
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

MAJOR® is a nasal decongestant that contains pseudoephedrine HCl (a medication that helps relieve nasal and sinus congestion). It is designed to temporarily relieve sinus congestion and pressure, as well as nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies. Each tablet contains 30 mg of the active ingredient, making it easy to manage your symptoms when you're feeling congested.

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 can take 2 tablets every 4 to 6 hours as needed. However, make sure not to exceed 8 tablets in a 24-hour period to avoid potential side effects.

For children between the ages of 6 and 11 years, the recommended dosage is 1 tablet every 4 to 6 hours, with a maximum of 4 tablets in a 24-hour period. It's important to note that this medication is not suitable for children under 6 years old, so please avoid using it for that age group. Always follow these guidelines to ensure safe and effective use of the medication.

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 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.

It's also important to follow the recommended dosage and not exceed it, as misuse can lead to serious health issues. Always prioritize your safety and well-being by adhering to these guidelines.

Side Effects

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

It's crucial not to use this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson’s disease, or if you have stopped taking an MAOI within the last two weeks. Before using this medication, talk to your doctor if you have diabetes, heart disease, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate. In case of an overdose, seek medical help or contact a Poison Control Center immediately.

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: diabetes, heart disease, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland. If you experience an overdose, seek emergency medical help or contact a Poison Control Center immediately.

You should stop using this product 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 or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you.

Always err on the side of caution—if you think you or someone else may have taken too much of a medication, don’t wait. Getting prompt assistance can be vital for safety and recovery.

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 between the ages of 6 and 11 years, they can take 1 tablet every 4 to 6 hours as needed, but it's important not to exceed 4 tablets in a 24-hour period. For children under 6 years old, this medication is not recommended, so please avoid using it for younger children. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about dosage or potential side effects with your doctor, as they can provide personalized guidance based on your health history and current medications.

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 be adjusted 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 changes 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 have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F). It can safely be kept within a range of 15°-30°C (59°-86°F) if necessary. Always check the packaging before use: if the outer package is opened or if the blister (the sealed compartment holding the product) is torn or broken, do not use it, as this indicates that the product may have been tampered with or compromised.

By following these storage and handling guidelines, you can help maintain the product's integrity and safety for your use.

Additional Information

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. Additionally, if you suspect an overdose, seek medical assistance or contact a Poison Control Center immediately.

FAQ

What is MAJOR® used for?

MAJOR® is a nasal decongestant that 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 active ingredient in MAJOR®?

The active ingredient in MAJOR® is pseudoephedrine HCl.

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

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

What should children aged 6 to 11 do?

Children ages 6 to 11 should take 1 tablet every 4 to 6 hours, not exceeding 4 tablets in 24 hours.

Is MAJOR® safe for children under 6?

No, MAJOR® should not be used in children under 6 years of age.

What should I do if I experience side effects?

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

Are there any contraindications for using MAJOR®?

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

What precautions should I take before using MAJOR®?

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

What should I do in case of overdose?

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

What should I do if I am pregnant or breastfeeding?

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

How should I store MAJOR®?

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

What should I do if the packaging is tampered with?

Do not use MAJOR® if the outer package is opened or if the blister unit is torn, broken, or shows any signs of tampering.

Packaging Info

Below are the non-prescription pack sizes of Pseudoephedrine Hcl. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pseudoephedrine Hcl.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

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 instructed to take 2 tablets every 4 to 6 hours as needed. The maximum allowable dosage is 8 tablets within a 24-hour period.

For children aged 6 to 11 years, the recommended dosage is 1 tablet every 4 to 6 hours, with a maximum of 4 tablets in a 24-hour period.

This medication 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), 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 uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage is also 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 minimum of two weeks following the cessation 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: diabetes, heart disease, thyroid disease, high blood pressure, or difficulty urinating due to prostate gland enlargement. These conditions may necessitate additional monitoring or adjustments in therapy.

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 improve 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 medication. 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.

Patients should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric or emotional disorders, or Parkinson’s disease, or for a period of 2 weeks following the cessation of an MAOI.

Before using this medication, patients with certain pre-existing conditions should consult a healthcare provider. These conditions include diabetes, heart disease, thyroid disease, high blood pressure, and difficulty in urination due to enlargement of the prostate gland.

In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Pseudoephedrine Hcl. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pseudoephedrine Hcl.
Details

Pediatric Use

Pediatric patients aged 6 to 11 years may take 1 tablet every 4 to 6 hours, with a maximum of 4 tablets in a 24-hour period. The use of this medication is not recommended for children under 6 years of age.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 on 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 not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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. 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 the severity of the symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

Nonclinical Toxicology

There are no teratogenic effects observed in the nonclinical studies conducted. Additionally, no non-teratogenic effects have been reported. The available data does not include specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Healthcare providers should counsel 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 fever.

It is important to remind patients not to exceed the recommended dosage while using this product. Providers should also recommend that patients consult a doctor before use if they have any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in a tamper-evident package. It is essential to avoid using the product 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°-30°C (59°-86°F). Proper handling and storage are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should be advised to consult a healthcare professional if they are pregnant or breastfeeding before using the medication. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Pseudoephedrine 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 Pseudoephedrine 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

Last AI update:

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.