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Tukol Children Cough and Congestion

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Active ingredients
  • Guaifenesin 50 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
  • Phenylephrine Hydrochloride 2.5 mg/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 2022
Label revision date
October 11, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 50 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
  • Phenylephrine Hydrochloride 2.5 mg/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 2022
Label revision date
October 11, 2024
Manufacturer
Genomma Lab USA
Registration number
M012
NDC root
50066-308
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Drug Overview

Tukol® is a medication designed for children aged 4 and older to help relieve cough and congestion associated with colds. It contains three active ingredients: dextromethorphan HBr (which helps suppress cough), guaifenesin (which helps loosen phlegm and thin bronchial secretions), and phenylephrine HCl (which helps reduce nasal congestion).

By working together, these ingredients temporarily alleviate symptoms such as nasal congestion, cough due to minor throat and bronchial irritation, and chest congestion, making it easier for your child to breathe and feel more comfortable.

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 works to alleviate these uncomfortable symptoms, making it easier for you to feel more comfortable.

Dosage and Administration

When using this medication, it's important to follow the dosing guidelines carefully to ensure safety and effectiveness. You should never take more than 6 doses within a 24-hour period. To measure your dose accurately, always use the dosing cup that comes with the product, and keep it handy for future use.

For children aged 6 to under 12 years, the recommended dose is 2 teaspoons (which is 10 mL) every 4 hours. If your child is between 4 and under 6 years old, they should take 1 teaspoon (5 mL) every 4 hours. However, if your child is under 4 years old, this medication should not be used. Always adhere to these guidelines to ensure the best care for your child.

What to Avoid

You should avoid using this product if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications often prescribed for depression, psychiatric, or emotional conditions, or for 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, it's important to consult with a doctor or pharmacist before proceeding.

Taking this precaution is crucial to prevent serious interactions and ensure your child's safety. Always prioritize open communication with healthcare professionals regarding any medications your child is using.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. If you notice nervousness, dizziness, or sleeplessness, it's best to stop using the medication and consult a doctor. Additionally, if symptoms do not improve within 7 days, or if you experience a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, seek medical advice as these could indicate a more serious condition.

It's crucial to avoid using this medication in children who are taking certain antidepressants known as monoamine oxidase inhibitors (MAOIs) or within two weeks of stopping them. Before using this medication, consult a doctor if your child has any of the following: heart disease, high blood pressure, thyroid disease, diabetes, or a chronic cough related to smoking or other respiratory conditions. Also, check with a doctor or pharmacist if your child is taking any other oral nasal decongestants or stimulants.

Warnings and Precautions

It's important to be cautious when using this medication, especially for children. Do not give it to a child who is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, or for two weeks after stopping an MAOI. If you're unsure whether your child's prescription includes an MAOI, please consult a doctor or pharmacist.

Before using this medication, check with a doctor if your child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or a chronic cough (like those caused by smoking or asthma). Also, 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. Additionally, 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.

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, and further studies are needed to fully understand these risks. Therefore, you should consult your doctor before using this product.

Use this product only if it is clearly necessary and after discussing it with your healthcare provider. There are no specific dosage modifications recommended for pregnant individuals, so it's crucial to have a conversation with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, it's important to talk to your healthcare professional before using this product. There is a possibility that it can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety and well-being of both you and your baby.

Pediatric Use

It's important to be cautious when giving medication to children. If your child is taking a prescription monoamine oxidase inhibitor (MAOI), do not use this medication, and wait at least two weeks after stopping the MAOI before considering it. Always consult your doctor before use if your child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema.

For children aged 4 and older, the recommended dosage is 2 teaspoons (10 mL) every 4 hours for those aged 6 to under 12 years, and 1 teaspoon (5 mL) every 4 hours for those aged 4 to under 6 years. Do not use this medication for children under 4 years old. Be sure not to exceed the recommended dosage, and stop use and consult a doctor if your child experiences nervousness, dizziness, or sleeplessness, if symptoms do not improve within 7 days, or if a cough lasts more than 7 days or is accompanied by fever, rash, or a persistent headache.

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 responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 change 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 adjustments 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 crucial to talk to your healthcare provider before using this medication, especially if your child is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain emotional conditions. This medication should not be given to a child who is on an MAOI or within two weeks of stopping it, as it can lead to serious interactions.

Additionally, if your child is taking any other oral nasal decongestants or stimulants, make sure to consult with a doctor or pharmacist first. This helps ensure that all medications are safe to use together and that your child receives the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 15-30°C (59-86°F). It's important not to refrigerate it, as this could affect its effectiveness.

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

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 children's cough and congestion medication that helps temporarily relieve symptoms associated with a cold, including nasal congestion and cough due to minor throat and bronchial irritation.

What are the active ingredients in Tukol®?

The active ingredients in Tukol® are Dextromethorphan HBr, Guaifenesin, and Phenylephrine HCl.

What is the recommended dosage for children?

For children aged 6 to under 12 years, the dosage is 2 teaspoons (10 mL) every 4 hours. For children aged 4 to under 6 years, it is 1 teaspoon (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 children taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor if unsure about your child's medication.

What should I do if my child experiences side effects?

Stop using Tukol® and consult a doctor if your child experiences nervousness, dizziness, sleeplessness, or if symptoms do not improve within 7 days or are accompanied by fever.

Is Tukol® safe to use during pregnancy?

The safety of Tukol® during pregnancy has not been established. Consult a healthcare provider before use if pregnant or planning to become pregnant.

Can nursing mothers use Tukol®?

Nursing mothers should consult a healthcare professional before using Tukol®, as there is potential for the medication to be excreted in breast milk.

How should Tukol® be stored?

Store Tukol® at 15-30°C (59-86°F) and do not refrigerate.

Packaging Info

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

Packaging configurations for Tukol Children Cough and Congestion.
Details

Drug Information (PDF)

This file contains official product information for Tukol 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 pharmaceutical formulation indicated for the relief of cough and congestion in children aged 4 years and older. The active ingredients include dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride. This product is presented in a liquid dosage form, with a total volume of 4 fluid ounces (118 milliliters). It is designed to alleviate symptoms associated with cough, nasal congestion, and chest congestion.

Uses and Indications

This drug is indicated for the relief of symptoms associated with colds, including nasal congestion and cough due to minor throat and bronchial irritation. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating drainage of the bronchial tubes.

Limitations of Use: This medication is intended for temporary relief of symptoms and is not a cure for colds or other underlying respiratory conditions.

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. Dosing should be measured exclusively with the dosing cup provided with the product, which should be kept with the product at all times.

For children aged 6 to under 12 years, the recommended dosage is 2 teaspoons (10 mL) every 4 hours. For children aged 4 to under 6 years, the dosage is 1 teaspoon (5 mL) every 4 hours. The 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), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a child's prescription includes an MAOI, consultation with a healthcare professional, such as a doctor or pharmacist, is advised prior to administration of this product.

Warnings and Precautions

The use of this medication 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. Healthcare professionals should advise parents or guardians to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

Prior to administration, it is essential to consult a healthcare provider if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, a consultation is warranted if the child presents with a cough that produces excessive phlegm (mucus).

Healthcare professionals should also inquire whether the child is taking any other oral nasal decongestants or stimulants before recommending this medication. It is critical to adhere to the recommended dosage, as exceeding this can lead to adverse effects.

If the child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within seven days or are accompanied by fever, the use of this medication should be discontinued, and a healthcare provider should be consulted. 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 requiring medical evaluation.

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

Side Effects

Patients using this medication may experience a range of adverse reactions. Serious adverse reactions include the potential for increased nervousness, dizziness, or sleeplessness. In such cases, patients are advised to discontinue use and consult a healthcare professional.

Common adverse reactions may manifest as persistent cough, particularly if it lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms could indicate a serious underlying condition, warranting immediate medical attention.

Patients should also be cautioned against using this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have ceased MAOI treatment within the past two weeks, as this combination may lead to significant adverse effects.

Before initiating treatment, it is recommended that patients consult a healthcare provider if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or chronic respiratory conditions such as asthma, chronic bronchitis, or emphysema. Additionally, patients should seek medical advice if they are experiencing a cough that produces excessive phlegm.

Furthermore, patients should inform their healthcare provider or pharmacist if they are taking any other oral nasal decongestants or stimulants, as this may increase the risk of adverse reactions.

Drug Interactions

The use of this medication 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 is advised to avoid administration for a period of two weeks following the discontinuation of an MAOI.

In cases where the child is receiving other oral nasal decongestants or stimulants, it is essential to consult with a healthcare professional, such as a doctor or pharmacist, prior to use. This precaution is necessary to prevent potential adverse interactions and ensure the safety and efficacy of the treatment.

Packaging & NDC

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

Packaging configurations for Tukol Children Cough and Congestion.
Details

Pediatric Use

Pediatric patients aged 4 years and older may use this medication, but specific precautions and dosing guidelines must be followed. For children aged 6 to under 12 years, the recommended dosage is 2 teaspoons (10 mL) every 4 hours. For those aged 4 to under 6 years, the dosage is 1 teaspoon (5 mL) every 4 hours. Use is not recommended for children under 4 years of age.

Caution is advised when administering this medication to pediatric patients with underlying health conditions. A healthcare professional should be consulted prior to use if the child has heart disease, high blood pressure, thyroid disease, diabetes, or a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, it is important to avoid use in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past 2 weeks.

Parents and caregivers should not exceed the recommended dosage. If the child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days or are accompanied by fever, medical advice should be sought. Furthermore, if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, a healthcare professional should be consulted.

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

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus. Further studies are needed to determine the safety profile of this product in pregnant individuals. No specific dosage modifications are provided for this population. It is recommended that this product be used only if clearly needed and after a thorough discussion with a healthcare provider regarding the potential risks and benefits.

Lactation

Lactating mothers should consult a healthcare professional 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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert text. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center 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. Monitoring vital signs and conducting a comprehensive evaluation will aid in determining the appropriate course of action.

Management of an overdose may involve supportive care, including the stabilization of the patient's airway, breathing, and circulation. Depending on the specific circumstances and the substance involved, additional interventions may be necessary. It is vital to follow established protocols and guidelines for the management of overdose cases to mitigate potential complications effectively.

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

No postmarketing experience details are available for SPL code 90375-7.

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, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

It is crucial to 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. Patients should be encouraged to consult with a doctor or pharmacist if they are uncertain whether their child's prescription includes an MAOI.

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.

Healthcare providers should also recommend that patients consult a doctor before using this medication if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients should be advised to seek guidance from a doctor or pharmacist if the child is taking any other oral nasal decongestant or stimulant.

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 15-30°C (59-86°F). 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 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 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.