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Tukol Max Action

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This product has been discontinued

Active ingredient
Oxymetazoline Hydrochloride 0.5 mg/1 mL
Other brand names
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 2021
Label revision date
December 13, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Oxymetazoline Hydrochloride 0.5 mg/1 mL
Other brand names
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 2021
Label revision date
December 13, 2023
Manufacturer
GENOMMA LAB USA, INC.
Registration number
M012
NDC root
50066-913
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

You may be looking for information about a nasal spray medication designed for use in adults and children aged 6 years and older. This medication is typically administered as 2 or 3 sprays in each nostril, allowing for relief from nasal congestion or other related symptoms. It is important to follow the recommended dosing guidelines and consult a doctor for children under 6 years of age.

To use the spray effectively, you should shake the bottle well, remove the safety seal, and follow the specific instructions for opening and administering the spray. This medication works by delivering active ingredients directly into the nasal passages, helping to alleviate discomfort.

Uses

This medication is used for individuals aged 6 years and older, including adults, to help relieve certain nasal symptoms. If you are between 6 and 12 years old, you can use 2 or 3 sprays in each nostril, but make sure to do this no more than every 10 to 12 hours, and do not exceed 2 doses in a 24-hour period. If you are under 6 years old, it's important to consult a doctor before using this medication.

It's worth noting that there are no reported teratogenic effects (which means it does not cause birth defects) associated with this medication, and there are also no nonteratogenic effects (which refer to other types of harmful effects that do not involve birth defects) mentioned. Always follow your healthcare provider's advice for the best results.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details such as how much to take, how often to take it, or how to apply it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.

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 can lead to issues such as worsening nasal congestion.

Be aware that frequent or prolonged use may increase the risk of nasal congestion returning or worsening. Always prioritize your health by adhering to these guidelines.

Side Effects

If you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland, it's important to consult your doctor before using this medication.

Should your symptoms continue despite using the medication, please stop using it and reach out to your doctor for further guidance.

Warnings and Precautions

Before using this medication, it's important to consult 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. These conditions may affect how the medication works for you.

If you accidentally swallow the medication, seek emergency medical help or contact a Poison Control Center immediately. Additionally, if your symptoms do not improve or persist, stop taking the medication and reach out to your doctor for further guidance. Your health and safety are the top priority, so don’t hesitate to ask for help when needed.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms of overdose mentioned, you should be aware that common signs can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or have concerns about an overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can provide important information to healthcare professionals. Remember, it's better to be safe and get checked if you think an overdose may have occurred.

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 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 no more than every 10 to 12 hours. It's important not to exceed 2 doses within a 24-hour period. Always supervise your child during use to ensure safety.

For children under 6 years of age, it's crucial to consult a doctor before using this medication. This ensures that you receive the appropriate guidance and care for your child's specific needs.

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. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations for patients with renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20-25ºC (68-77ºF). It's important to keep the original carton, as it contains the full labeling and important information you may need later.

When handling the product, always do so with care to maintain its integrity. Following these simple storage and handling guidelines will help ensure your product remains safe and effective for use.

Additional Information

You should use this medication through the nose (nasal administration). For adults and children aged 6 to under 12 years, the recommended dose is 2 or 3 sprays in each nostril, but you should not use it more than once every 10 to 12 hours, and do not exceed 2 doses in a 24-hour period. If your child is under 6 years old, consult a doctor before use.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. Always keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

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

For adults and children aged 6 to under 12 years (with adult supervision), the recommended dosage is 2 or 3 sprays in each nostril not more often than every 10 to 12 hours, and do not exceed 2 doses in any 24-hour period.

What should I do if my child is under 6 years old?

If your child is under 6 years of age, you should consult a doctor before use.

What are the instructions for using the nasal spray?

Shake well before use, remove the safety seal, and to spray, hold the bottle with your thumb at the base and the nozzle between your first and second fingers. Insert the nozzle into the nostril, fully depress the rim, and sniff deeply.

Are there any warnings I should be aware of?

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

What should I do if symptoms persist?

If symptoms persist, stop use and ask a doctor for further advice.

What should I do if the spray is swallowed?

If swallowed, get medical help or contact a Poison Control Center right away.

Can I use this medication if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before use.

How should I store this medication?

Store the medication at room temperature between 20-25ºC (68-77ºF) and keep the carton for full labeling.

Is there a risk of dependence or abuse?

Frequent or prolonged use may cause nasal congestion to recur or worsen, but there are no specific dependence concerns mentioned.

Packaging Info

Below are the non-prescription pack sizes of Tukol Max Action (oxymetazoline hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tukol Max Action.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description.

Uses and Indications

This drug is indicated for the relief of nasal congestion in adults and children aged 6 to under 12 years, to be administered as 2 or 3 sprays in each nostril, not more frequently than every 10 to 12 hours. The maximum allowable dosage is 2 doses within a 24-hour period.

For children under 6 years of age, consultation with a healthcare professional is recommended prior to use.

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

Dosage and Administration

No dosage and administration information is available for this product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

Contraindications

Use is contraindicated in patients who exceed the recommended dosage or duration of use. Specifically, the product should not be used for more than 3 consecutive days, as prolonged use may lead to a recurrence or worsening of nasal congestion. Adherence to the directed usage is essential to mitigate these risks.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. These conditions may increase the risk of adverse effects and require careful consideration before initiating treatment.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients are advised to contact a Poison Control Center or seek emergency medical help without delay.

If symptoms persist despite treatment, patients must discontinue use and consult their healthcare provider for further evaluation and guidance. Monitoring of symptoms and regular follow-up may be necessary to ensure safe and effective use of the medication.

Side Effects

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

In the event that symptoms persist, patients are instructed to discontinue use and seek medical advice. This precaution is essential to ensure the safety and well-being of individuals with underlying health conditions.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Tukol Max Action (oxymetazoline hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tukol Max Action.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive 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. For children under 6 years of age, consultation with a doctor is advised prior to use.

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 potential adverse effects or changes in efficacy, 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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if symptoms persist. It is important to emphasize that the product should not be used more than directed and should not be used for longer than three days. Patients must adhere strictly to the recommended usage guidelines.

While using the product, patients should be made aware that frequent or prolonged use may lead to a recurrence or worsening of nasal congestion. They should also be informed that temporary discomfort, such as burning, stinging, sneezing, or an increase in nasal discharge, may occur during use.

Additionally, healthcare providers should caution patients against sharing the container with others, as this may increase the risk of spreading infection.

Storage and Handling

The product is supplied in a carton that should be retained for complete labeling information. It is essential to store the product at room temperature, specifically within the range of 20-25ºC (68-77ºF). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered via the nasal route. For adults and children aged 6 to under 12 years, the recommended dosage is 2 or 3 sprays in each nostril, not to be taken more frequently than every 10 to 12 hours, with a maximum of 2 doses in a 24-hour period. For children under 6 years of age, consultation with a healthcare provider is advised prior to use.

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, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Tukol Max Action, 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 Tukol Max Action, 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.