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Major

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Active ingredient
Oxymetazoline Hydrochloride 0.05 g/100 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Spray
Route
Nasal
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
September 12, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride 0.05 g/100 mL
Other brand names
Drug class
Vasoconstrictor
Dosage form
Spray
Route
Nasal
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
September 12, 2025
Manufacturer
MAJOR PHARMACEUTICALS
Registration number
M012
NDC root
0904-7006
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 spray that contains oxymetazoline HCl (0.05%), which helps relieve nasal congestion caused by the common cold, hay fever, and other upper respiratory allergies. It works by shrinking swollen nasal membranes, making it easier for you to breathe. The effects begin within seconds and can last for up to 12 hours, providing all-day or all-night relief without causing drowsiness.

Uses

If you're dealing with nasal congestion from a common cold, hay fever, or other upper respiratory allergies, this medication can help provide temporary relief. It works by shrinking swollen nasal membranes, making it easier for you to breathe. Additionally, it can relieve sinus congestion and pressure, helping you feel more comfortable.

Dosage and Administration

When using this medication, adults and children aged 6 to under 12 years should spray 2 or 3 times in each nostril, but only every 10 to 12 hours. It's important not to exceed 2 doses in a 24-hour period. If your child is under 6 years old, please consult a doctor before use.

To prepare the spray, push down firmly on the cap and turn it counterclockwise. When you're ready to spray, squeeze the bottle quickly and firmly, making sure not to tilt your head backward while doing so. After each use, wipe the nozzle clean and secure the cap to keep it safe for the next time.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should not use it for more than three days, and always follow the directions provided. Using it more than directed or for an extended period can lead to a worsening of nasal congestion or cause it to return after stopping the medication.

To protect yourself, avoid using this medication in a way that exceeds the recommended dosage. Adhering to these guidelines will help you achieve the best results while minimizing any potential risks.

Side Effects

If you experience any persistent symptoms while using this medication, it's important to stop use and consult your doctor. Additionally, you should talk to your doctor before using this medication if you have any of the following conditions: heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland.

Being aware of these factors can help ensure your safety and the effectiveness of your treatment. Always prioritize open communication with your healthcare provider regarding your health conditions.

Warnings and Precautions

If you accidentally swallow this medication, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your safety is a priority, so don’t hesitate to reach out for assistance.

You should stop using this medication and consult your doctor if your symptoms continue despite treatment. It’s essential to keep an open line of communication with your healthcare provider to ensure your well-being.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand to provide healthcare professionals with important information about what was taken. Remember, it's better to be safe and get checked out if you have any concerns.

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 your child is under 6 years old, it's important to consult a doctor before using this medication. For children aged 6 to under 12 years, you can administer 2 or 3 sprays in each nostril, but make sure to do this only every 10 to 12 hours. It's crucial not to exceed 2 doses within a 24-hour period, and adult supervision is recommended during use. Always prioritize your child's safety and well-being by following these guidelines.

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, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to help manage your overall care effectively.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your renal function, which refers to how well your kidneys are working, can affect how your body processes certain medications. Your healthcare provider will monitor your renal function regularly, especially through tests that measure creatinine clearance (a test that estimates how well your kidneys filter waste).

Before starting any new treatment, your renal function should be assessed, and ongoing tests will be necessary to ensure your safety. If you have moderate to severe renal impairment, you may require a reduced dose of your medication. Always communicate with your healthcare team about your kidney health to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that your condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Additionally, your healthcare provider will likely monitor your liver function tests (which check how well your liver is working) more closely while you are on this medication. Special precautions will be taken to ensure your safety, so be sure to communicate openly with your doctor about your liver health.

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 use of your product, store it at room temperature. This helps maintain its effectiveness and safety. It's also important to keep the carton, as it contains valuable information and labeling that you may need for future reference.

By following these simple storage guidelines, you can help ensure that your product remains in optimal condition for use.

Additional Information

The medication is administered through the nasal route. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Additionally, keep it out of reach of children. If the medication is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is MAJOR®?

MAJOR® is a nasal decongestant spray that contains the active ingredient Oxymetazoline HCl 0.05%.

What conditions does MAJOR® relieve?

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

How quickly does MAJOR® work?

MAJOR® starts to work in seconds and provides up to 12 hours of nasal congestion relief without causing drowsiness.

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

Adults and children aged 6 to under 12 should use 2 or 3 sprays in each nostril not more often than every 10 to 12 hours, and should not exceed 2 doses in any 24-hour period.

What should I do if I am pregnant or breastfeeding?

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

Are there any warnings associated with MAJOR®?

You should stop use and ask a doctor if symptoms persist, and consult a doctor before use if you have heart disease, high blood pressure, diabetes, thyroid disease, or trouble urinating due to an enlarged prostate gland.

How should MAJOR® be stored?

MAJOR® should be stored at room temperature and kept out of reach of children.

What should I do if I accidentally swallow MAJOR®?

If swallowed, you should get medical help or contact a Poison Control Center right away at (1-800-222-1222).

Can MAJOR® be used for more than 3 days?

No, you should not use MAJOR® for more than 3 days, as frequent or prolonged use may cause nasal congestion to recur or worsen.

Packaging Info

Below are the non-prescription pack sizes of Major (nasal decongestant). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Major.
Details

Drug Information (PDF)

This file contains official product information for Major, 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 nasal congestion associated with the common cold, hay fever, and other upper respiratory allergies. It also provides temporary relief of sinus congestion and pressure. Additionally, this drug acts to shrink swollen nasal membranes, facilitating easier breathing.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 6 to under 12 years of age, when administered under adult supervision, may receive 2 or 3 sprays in each nostril. Dosing should not occur more frequently than every 10 to 12 hours, and it is important not to exceed 2 doses within a 24-hour period. For children under 6 years of age, consultation with a physician is recommended prior to use.

To prepare the device for administration, the user should push firmly down on the cap and turn it counterclockwise. During the spraying process, the user must squeeze the bottle quickly and firmly while ensuring that the head is not tilted backward. After use, the nozzle should be wiped clean, and the cap should be securely replaced to maintain the integrity of the product.

Contraindications

Use of this product is contraindicated in patients who exceed the directed dosage or utilize it for more than three consecutive days. Prolonged or frequent use may lead to a recurrence or worsening of nasal congestion.

Warnings and Precautions

In the event of accidental ingestion, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center at (1-800-222-1222) without delay.

Patients should discontinue use and consult a physician if symptoms persist. Continuous monitoring of the patient's condition is essential to ensure appropriate management and intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. In the event that symptoms persist, it is advised to stop use and consult a healthcare professional.

Before initiating treatment, patients with certain pre-existing conditions should seek medical advice. Specifically, individuals with heart disease, high blood pressure, diabetes, thyroid disease, or those experiencing difficulty urinating due to an enlarged prostate gland should consult their doctor prior to use.

These precautions are essential to ensure the safe and effective use of the medication, minimizing the risk of serious adverse reactions.

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 Major (nasal decongestant). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Major.
Details

Pediatric Use

Pediatric patients under 6 years of age should consult a healthcare professional before use. For children aged 6 to under 12 years, the recommended dosage is 2 or 3 sprays in each nostril, administered no more frequently than every 10 to 12 hours. It is important not to exceed 2 doses within a 24-hour period. Adult supervision is advised for this age group during administration.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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 mothers.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels, with reduced doses potentially required for those with moderate to severe renal impairment. Renal function tests should be performed prior to initiating therapy and periodically thereafter to ensure appropriate dosing and to mitigate the risk of adverse effects.

Hepatic Impairment

Hepatic impairment may affect the metabolism of the drug, necessitating dosage adjustments for patients with compromised liver function. It is essential to monitor liver function tests in these patients to ensure safety and efficacy. Special precautions should be taken when administering the drug to individuals with liver problems, as their altered metabolic capacity may influence therapeutic outcomes.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified that temporary discomfort, including symptoms such as burning, stinging, sneezing, or an increase in nasal discharge, may occur following the use of the product. Additionally, it has been reported that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at (1-800-222-1222) if the product is swallowed. Patients should be informed to discontinue use and consult a doctor if symptoms persist.

When using this product, it is essential to instruct patients not to exceed the recommended dosage and to limit use to no more than three days. Patients should be cautioned that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. They should also be made aware that temporary discomfort, such as burning, stinging, sneezing, or an increase in nasal discharge, may occur during use.

Healthcare providers should emphasize the importance of using this product individually, as sharing the container with others may facilitate the spread of infection.

Additionally, patients should be encouraged to consult a doctor prior to use if they have any of the following conditions: heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland.

Storage and Handling

The product is supplied in a carton that should be retained for future reference regarding the complete labeling information. It is essential to store the product at room temperature to maintain its integrity and effectiveness.

Additional Clinical Information

The route of administration for the medication is nasal. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is also important to keep the medication out of reach of children; if ingested, patients should seek medical assistance or contact a Poison Control Center immediately at (1-800-222-1222). No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Major, 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 Major, 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.