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Tukol Honey Children Cough and Congestion

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Active ingredients
  • Guaifenesin 50 mg/2.5 mL
  • Dextromethorphan Hydrobromide 5 mg/2.5 mL
  • Phenylephrine Hydrochloride 2.5 mg/2.5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Syrup
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
October 18, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 50 mg/2.5 mL
  • Dextromethorphan Hydrobromide 5 mg/2.5 mL
  • Phenylephrine Hydrochloride 2.5 mg/2.5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Syrup
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 2020
Label revision date
October 18, 2024
Manufacturer
Genomma Lab USA
Registration number
M012
NDC root
50066-301
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

Tukol® is a cough and congestion formulation designed specifically for children aged 4 and above. It contains three active ingredients: Dextromethorphan HBr (which helps suppress cough), Guaifenesin (which helps loosen phlegm and thin bronchial secretions), and Phenylephrine HCl (which relieves nasal congestion). With a pleasant natural honey flavor, Tukol® aims to temporarily relieve symptoms associated with colds, such as cough, nasal congestion, and chest congestion.

By helping to clear mucus from the bronchial tubes and easing throat irritation, Tukol® provides support for children dealing with cold symptoms, making it easier for them to breathe and feel more comfortable. It is available in a convenient 4 FL OZ (118 ml) bottle.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions, which allows for better drainage of your bronchial tubes. If you're experiencing symptoms from a cold, such as nasal congestion or a cough caused by minor irritation in your throat and bronchial area, this medication can provide temporary relief.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

Dosage and Administration

When using this medication, it's important to follow the dosing instructions carefully to ensure safety and effectiveness. You should not take more than 6 doses within a 24-hour period. Always measure your dose using the dosing cup that comes with the product, and keep this cup with the medication to avoid any confusion.

For children aged 6 to under 12 years, the recommended dose is 5 milliliters (mL) every 4 hours. If your child is between 4 and under 6 years old, the dose is 2.5 mL every 4 hours. Please remember that this medication is not suitable for children under 4 years of age. Always consult with a healthcare professional if you have any questions or concerns about dosing.

What to Avoid

You should avoid using this product in children who 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, do not use this product for at least two weeks after stopping an MAOI. If you're unsure whether your child's medication includes an MAOI, please consult a doctor or pharmacist.

It's also important to follow the recommended dosage carefully and not exceed it. Taking more than the advised amount can lead to serious health risks. Always prioritize safety and seek guidance if you have any questions or concerns.

Side Effects

If you notice nervousness, dizziness, or trouble sleeping 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, persistent headache, or a cough that lasts more than a week or returns with fever or rash, seek medical advice, as these could indicate a more serious condition.

Before using this medication for a child, check with a doctor if they have any of the following: heart disease, diabetes, high blood pressure, thyroid disease, a chronic cough (like asthma), or a cough with excessive mucus. Also, avoid using this medication if the child is taking certain antidepressants known as monoamine oxidase inhibitors (MAOIs) or has taken them in the past two weeks. Always follow the recommended dosage, and in case of an overdose, contact medical help or a Poison Control Center immediately.

Warnings and Precautions

You should not give this medication to a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, or for two weeks after stopping such medication. If you're unsure whether your child's prescription includes an MAOI, please consult a doctor or pharmacist first.

Before using this product, it's important to check with a doctor if your child has any of the following conditions: heart disease, diabetes, high blood pressure, thyroid disease, or a chronic cough, especially if it produces a lot of mucus. Additionally, consult a doctor or pharmacist if your child is taking any other oral nasal decongestants or stimulants. Always follow the recommended dosage and keep the medication out of reach of children.

If your child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within seven days or are accompanied by a fever, stop using the medication and contact a doctor. Also, if a cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, seek medical advice, as these could indicate a more serious issue. In case of an overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help right away. You can contact a Poison Control Center at 1-800-222-1222 for immediate assistance. 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. Your safety is the top priority, so act quickly.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. There may be potential risks to your fetus, so you should approach its use with caution. Always consult your doctor before using this product to discuss any concerns and to ensure it is safe for you and your baby.

Currently, there are no specific dosage modifications provided for pregnant individuals. Therefore, it's essential to seek guidance from a healthcare professional regarding the appropriate use and any necessary adjustments. Your health and the health of your baby are the top priority, so don't hesitate to reach out for advice.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, exercising caution is advised. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

It's important to be cautious when giving medication to children. You should not use this medication if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks. Before using it, consult a doctor if your child has any of the following conditions: heart disease, diabetes, high blood pressure, thyroid disease, or a chronic cough, especially if it involves a lot of mucus. Additionally, check with a doctor or pharmacist if your child is taking any other oral nasal decongestants or stimulants.

Make sure to follow the recommended dosages: for children aged 6 to under 12 years, give 5 mL every 4 hours; for those aged 4 to under 6 years, give 2.5 mL every 4 hours; and do not use this medication for children under 4 years old. Never exceed the recommended dosage. If your child experiences nervousness, dizziness, or sleeplessness, or if their symptoms do not improve within 7 days or worsen with fever, rash, or persistent headache, stop use and consult a doctor.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 condition. 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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to be cautious when considering this medication for your child. You should not use it if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression or certain emotional conditions. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your child's medication includes an MAOI, please consult a doctor or pharmacist.

Before giving this medication, also check with a healthcare professional if your child is taking any other oral nasal decongestants or stimulants. Discussing all medications and treatments with your healthcare provider helps ensure safety and effectiveness.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 15-30ºC (59-86ºF). It's important to avoid refrigeration, as this can affect the product's effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety instructions provided to ensure safe and effective use.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is Tukol® used for?

Tukol® is a cough and congestion formulation for children that helps relieve cough, nasal congestion, and chest congestion.

What are the active ingredients in Tukol®?

Tukol® contains Dextromethorphan HBr, Guaifenesin, and Phenylephrine HCl, with a natural honey flavor.

What is the recommended dosage for children?

For children 6 to under 12 years, the dosage is 5 mL every 4 hours. For children 4 to under 6 years, it is 2.5 mL every 4 hours. Do not use in children under 4 years.

Are there any contraindications for using Tukol®?

Do not use Tukol® in a child taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if my child experiences side effects?

Stop use and ask a doctor if your child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days.

Is Tukol® safe to use during pregnancy?

The safety of Tukol® during pregnancy has not been established, so consult a doctor before use if pregnant or planning to become pregnant.

Can nursing mothers use Tukol®?

Nursing mothers should consult a doctor before using Tukol®, as there is potential for excretion in breast milk.

How should Tukol® be stored?

Store Tukol® at 15-30ºC (59-86ºF) and do not refrigerate.

Packaging Info

Below are the non-prescription pack sizes of Tukol Honey Children Cough and Congestion (dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tukol Honey Children Cough and Congestion.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Tukol® is a cough and congestion formulation designed for children aged 4 years and older. It contains a combination of active ingredients: Dextromethorphan HBr, Guaifenesin, and Phenylephrine HCl. This product is presented in a liquid dosage form with a natural honey flavor, providing a palatable option for pediatric use. Each bottle contains 4 fluid ounces (118 ml) and is indicated for the relief of cough, nasal congestion, and chest congestion.

Uses and Indications

This drug is indicated for the relief of symptoms associated with colds, specifically nasal congestion and cough due to minor throat and bronchial irritation. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

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

Dosage and Administration

The maximum recommended dosage should not exceed six doses within a 24-hour period. Healthcare professionals are advised to measure the dosage exclusively with the dosing cup provided, which should be kept with the product at all times.

For children aged 6 to under 12 years, the recommended dosage is 5 mL administered every 4 hours as needed. For children aged 4 to under 6 years, the appropriate dosage is 2.5 mL every 4 hours as needed. It is important to note that this product is not recommended for use in children under 4 years of age.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a child's prescription, consultation with a healthcare professional is advised prior to use.

Additionally, it is contraindicated to exceed the recommended dosage of this product.

Warnings and Precautions

The use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to administration.

Healthcare professionals should advise caregivers to seek medical guidance before using this product if the child has any of the following conditions: heart disease, diabetes, high blood pressure, thyroid disease, a chronic cough (such as that associated with asthma), or a cough accompanied by excessive phlegm (mucus). Additionally, it is essential to consult a doctor or pharmacist if the child is concurrently taking any other oral nasal decongestants or stimulants.

Caregivers must adhere strictly to the recommended dosage and should not exceed it. If the child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within seven days or are accompanied by fever, it is crucial to discontinue use and consult a healthcare provider. Furthermore, if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, these may indicate a serious condition, and medical advice should be sought.

To ensure safety, this product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be obtained, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients may experience a range of adverse reactions while using this product. It is important to monitor for serious symptoms and seek medical advice if they occur. Patients should stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, these may indicate a serious condition requiring medical evaluation.

Before using this product, it is advisable for patients to consult a healthcare professional if the child has any of the following conditions: heart disease, diabetes, high blood pressure, thyroid disease, a chronic cough such as that associated with asthma, or a cough that produces excessive phlegm (mucus).

Furthermore, it is critical to avoid using this product in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is essential to consult a doctor or pharmacist prior to use.

Patients should adhere to the recommended dosage and avoid exceeding it. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

The use of this product is contraindicated in pediatric patients who are concurrently 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 administered for a period of two weeks following the discontinuation of an MAOI. Caregivers are advised to consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

Furthermore, it is recommended that caregivers seek guidance from a healthcare provider prior to using this product if the child is currently taking any other oral nasal decongestants or stimulants. This precaution is essential to avoid potential pharmacodynamic interactions that may exacerbate side effects or lead to adverse clinical outcomes.

Packaging & NDC

Below are the non-prescription pack sizes of Tukol Honey Children Cough and Congestion (dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tukol Honey Children Cough and Congestion.
Details

Pediatric Use

Pediatric patients should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Prior to administration, it is essential to consult a healthcare professional if the child has any of the following conditions: heart disease, diabetes, high blood pressure, thyroid disease, a chronic cough (such as that associated with asthma), or a cough accompanied by excessive phlegm.

Caution is advised if the child is taking any other oral nasal decongestant or stimulant. The recommended dosages are as follows: for children aged 6 to under 12 years, 5 mL every 4 hours; for children aged 4 to under 6 years, 2.5 mL every 4 hours. Use is not recommended for children under 4 years of age.

It is important not to exceed the recommended dosage. Parents or caregivers should discontinue use and consult a doctor if the child experiences nervousness, dizziness, or sleeplessness, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache.

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

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. There may be potential risks to the fetus; therefore, use should be approached with caution. No specific dosage modifications for pregnant individuals are provided; healthcare professionals should be consulted for guidance regarding the use of this product in pregnant patients.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt action is crucial to ensure the safety and well-being of the patient.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential.

Management of an overdose typically involves supportive care and symptomatic treatment. It is important to monitor the patient closely for any adverse effects and to provide appropriate interventions as necessary.

In all cases of suspected overdose, the involvement of poison control and emergency medical services is recommended to facilitate optimal management and care.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Providers should inform patients that this medication should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such a medication. If there is uncertainty regarding whether a child's prescription includes an MAOI, patients should be encouraged to consult with a doctor or pharmacist prior to using this product.

Patients should be instructed to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, or if a cough persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache, they should seek medical advice, as these may indicate a serious condition.

It is important to emphasize that patients should not exceed the recommended dosage. Healthcare providers should also recommend that patients consult a doctor before use if the child has any of the following conditions: heart disease, diabetes, high blood pressure, thyroid disease, a chronic cough such as that associated with asthma, or a cough that produces excessive phlegm (mucus).

Lastly, patients should be advised to speak with a doctor or pharmacist before using this medication if the child is taking any other oral nasal decongestant or stimulant to avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 15-30ºC (59-86ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain product efficacy and safety.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Tukol Honey Children Cough and Congestion, 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 Honey Children Cough and Congestion, 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.

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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.