Tukol Cough and Congestion

Description

Tukol® is a multi-symptom formulation indicated for the relief of cough, nasal congestion, and chest congestion. The active ingredients include Dextromethorphan HBr, Guaifenesin, and Phenylephrine HCl. This product is suitable for individuals aged 12 years and older. It is provided in a liquid dosage form, with a total volume of 4 fluid ounces (118 ml).

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

Adults and children aged 12 years and over are advised to take 2 teaspoons (10 ml) every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period to avoid potential overdose.

This product is not intended for use in children under 12 years of age. Healthcare professionals should ensure that the dosing cup provided is used for accurate measurement, and it should be kept with the product at all times to facilitate proper dosing.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if they are uncertain whether their prescription medication contains an MAOI.

Warnings and Precautions

Use of this product is contraindicated in individuals currently 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 used for a period of two weeks following the cessation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if they are uncertain whether their prescription includes an MAOI.

Prior to administration, it is essential for patients to seek medical advice if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough that is productive of excessive phlegm. Patients with chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should also consult a healthcare provider before use.

Patients should be cautioned against the concurrent use of this product with any other oral nasal decongestants or stimulants without prior consultation with a healthcare professional.

It is imperative that patients adhere to the recommended dosage and not exceed it. If patients experience symptoms such as nervousness, dizziness, or insomnia, they should discontinue use and consult a doctor. Furthermore, if symptoms do not improve within seven days or are accompanied by fever, or if a cough persists beyond seven days, recurs, or is associated with fever, rash, or a persistent headache, patients should seek medical attention, as these may indicate a serious condition.

This product should be stored out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may necessitate immediate medical attention. Patients are advised to stop use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, 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, these may indicate a serious condition requiring further evaluation.

Common adverse reactions may include those related to specific pre-existing health conditions. Patients should consult a doctor before using this product if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Furthermore, individuals with a cough that produces excessive phlegm or those with chronic coughs associated with smoking, asthma, chronic bronchitis, or emphysema should seek medical advice prior to use.

It is important to note that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric, or emotional conditions, or Parkinson's disease. Patients should refrain from using this product for at least 2 weeks after discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, patients should consult a doctor or pharmacist.

Patients are also cautioned against exceeding the recommended dosage. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this product while on MAOIs or for a period of two weeks following the discontinuation of an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Patients uncertain about whether their prescription includes an MAOI are advised to consult a healthcare professional prior to using this product.

Additionally, it is recommended that patients seek guidance from a healthcare provider before using this product in conjunction with any other oral nasal decongestants or stimulants. This precaution is essential to avoid potential adverse interactions.

Packaging & NDC

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

Pediatric Use

This adult strength product is not intended for use in pediatric patients under 12 years of age. Children under 12 years should not use this medication.

Geriatric Use

Elderly patients may require careful consideration when using this adult strength product, which is not intended for use in children under 12 years of age. It is essential for healthcare providers to assess the appropriateness of this medication in geriatric patients, particularly those aged 65 and older, due to potential differences in pharmacokinetics and pharmacodynamics associated with aging.

Healthcare providers should monitor elderly patients closely for any adverse effects and consider the need for dosage adjustments based on individual patient factors, including renal and hepatic function. Caution is advised when prescribing this medication to geriatric patients, as they may be more susceptible to side effects and may have comorbidities that could influence treatment outcomes.

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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain alert to the signs of overdose and to act swiftly to ensure patient safety and optimal outcomes.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, there are no details provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

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

Patients should be informed that this medication should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should consult their doctor or pharmacist prior to using this product.

Healthcare providers should counsel patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop using the medication and seek medical advice if their symptoms do not improve within 7 days or if they are accompanied by fever. Patients should also be instructed to stop use and contact a doctor if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

It is important for healthcare providers to recommend that patients consult a doctor before using this medication if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek medical advice if they have a cough that produces excessive phlegm or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Lastly, patients should be encouraged to ask their doctor or pharmacist before using this medication if they are 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. For adults and children aged 12 years and older, the recommended dosage is 2 teaspoons (10 ml) every 4 hours. It is contraindicated for use in children under 12 years of age. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

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