Tukol X-Pecto Miel

Description

Tukol X-PECTO MIEL is a combination product containing dextromethorphan HBr, guaifenesin, and phenylephrine HCl, formulated as a cough suppressant, expectorant, and nasal decongestant. This product is indicated for individuals aged 12 years and older. It is presented in a liquid dosage form with a natural honey flavor, designed to quiet cough, thin and loosen phlegm, and clear nasal congestion. The product is available in a volume of 4 fluid ounces (118 ml) and is distributed by Genomma Lab USA Inc., located in Houston, TX, 77027.

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 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 recommended dosage for adults and children aged 12 years and older is 2 teaspoons 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 this guideline is strictly followed to maintain patient safety and efficacy of treatment.

Contraindications

Use of this product is contraindicated in patients with the following conditions:

Patients with heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland should consult a healthcare professional before use. Additionally, this product is contraindicated in individuals experiencing a cough associated with excessive phlegm or chronic coughs, such as those related to smoking, asthma, chronic bronchitis, or emphysema.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

It is imperative that this product not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be taken for a minimum of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is any uncertainty regarding the presence of an MAOI in their current prescription medications.

Patients are instructed to discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or insomnia. Furthermore, if symptoms do not improve within seven days or are accompanied by fever, medical consultation is necessary. A cough that persists beyond seven days, recurs, or is associated with fever, rash, or a persistent headache warrants immediate medical evaluation, as these may indicate a more serious underlying condition.

In the event of an overdose, it is crucial to obtain emergency medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and patients are advised to discontinue use and consult a healthcare professional if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they are accompanied by fever, patients should seek medical advice. A persistent cough lasting more than 7 days, or one that recurs or is accompanied by fever, rash, or a persistent headache, may indicate a serious underlying condition and warrants immediate medical attention.

Common adverse reactions may include those related to specific pre-existing conditions. Patients with heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland should consult a doctor or pharmacist prior to use. Furthermore, individuals with a cough that produces excessive phlegm or those with chronic cough conditions, such as smoking-related cough, asthma, chronic bronchitis, or emphysema, should also seek professional guidance before using this medication.

It is important to note that this medication should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such treatment, as this may lead to serious adverse effects.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this product while currently taking an MAOI or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

Additionally, it is recommended that patients seek guidance from a healthcare professional 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 X-Pecto Miel (dextromethorphan hydrobromide, guaifenesin, 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 in this age group should not be administered this medication, as it may pose safety concerns.

Geriatric Use

Elderly patients should be aware that this adult strength product is not intended for use in individuals under 12 years of age. It is crucial for geriatric patients to consult with a healthcare provider prior to use, particularly if they have pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or difficulties with urination due to an enlarged prostate gland.

Given the potential for increased sensitivity to medications in the elderly population, careful monitoring and consideration of individual health status are recommended. Healthcare providers should assess the appropriateness of this product for geriatric patients, taking into account any comorbidities that may influence safety and efficacy.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 available data 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 absence of detailed information necessitates careful clinical judgment and monitoring.

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 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 excessive dosing. Symptoms of overdosage 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 implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment and follow-up 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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including manifestations such as rash, pruritus, and urticaria. Gastrointestinal disturbances have also been reported, with nausea and vomiting being the most common symptoms. Additionally, central nervous system effects, including dizziness and drowsiness, have been observed.

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 to discontinue 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, patients should be advised to seek medical advice. It is also important to instruct patients to stop use and consult a doctor if a 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.

Before using this product, patients should be encouraged to consult with a doctor or pharmacist if they are currently taking any other oral nasal decongestants or stimulants. Patients must be reminded to adhere strictly to the recommended dosage and not exceed the directed amount.

Healthcare providers should also discuss the importance of consulting a doctor before use if patients have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients should 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.

Storage and Handling

The product is supplied with a dosage cup included for accurate measurement. It should be stored at a temperature range of 20‐25 °C (68‐77 °F). It is important to note that refrigeration is not recommended for this product. Proper storage conditions will help maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)