Tukol Max Action Severe Congestion and Cough

Description

Tukol® MAX ACTION is a combination product containing Dextromethorphan HBr, Guaifenesin, and Phenylephrine HCl, indicated for the relief of cough, nasal congestion, and chest congestion in individuals aged 12 years and older. The product is supplied in a liquid dosage form with a volume of 6 fluid ounces (177 mL). It is distributed by Genomma Lab USA, Inc., located in Houston, TX 77098. A seal warning is included, stating that the product should not be used if the printed seal under the cap is torn or missing.

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

Adults and children 12 years of age and older are advised to take 20 mL every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period. This product is not intended for use in children under 12 years of age.

Healthcare professionals should instruct patients to measure the dosage using the dosing cup provided with the product. It is essential to keep the dosing cup with the product to ensure accurate measurement.

Contraindications

There are no explicit contraindications identified for this product. However, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dosage may pose risks to patient safety.

Warnings and Precautions

Patients should not use this product 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 at least two weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescribed medication, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Patients are advised to discontinue use and seek medical attention if they experience symptoms such as nervousness, dizziness, or insomnia. Furthermore, 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, it is crucial to contact a healthcare provider. These symptoms may indicate a more serious underlying condition.

In the event of an overdose, immediate medical assistance should be sought, or the patient should 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 it is crucial to discontinue use and consult a healthcare professional if any of the following symptoms arise: 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 medical attention.

Patients are advised against using this medication concurrently with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping an MAOI, as this combination may lead to significant adverse effects.

Before initiating treatment, patients should consult a healthcare provider if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Caution is also advised for those experiencing a cough that produces excessive phlegm or has a chronic nature, such as that associated with smoking, asthma, chronic bronchitis, or emphysema.

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 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 current prescription, it is advised to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

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 Max Action Severe Congestion and Cough (dextromethorphan hbr, guaifenesin, phenylephrine hcl). 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. The safety and efficacy of this medication have not been established in children in this age group, and it is contraindicated for use in individuals under 12 years. Therefore, healthcare professionals should exercise caution and refrain from prescribing this product to children under 12.

Geriatric Use

Elderly patients may require special consideration when using this product. It is not intended for use in children under 12 years of age. Prior to use, geriatric patients should consult a healthcare provider if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland.

It is crucial for elderly patients to adhere to the recommended dosage and not exceed it. Monitoring for adverse effects is advised; patients should discontinue use and seek medical advice 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, it is important to consult a healthcare provider. Persistent cough lasting more than 7 days, or a cough that recurs or is associated with fever, rash, or a persistent headache, also warrants medical evaluation.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure informed decision-making regarding their health and the health of their fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is limited information available regarding the excretion of this drug in human breast milk and 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, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, 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: nervousness, dizziness, and sleeplessness. These reactions have been observed in patients using Tukol MAX ACTION Severe Congestion & Cough.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. Patients should be instructed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

It is important for healthcare providers to inform patients 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. Additionally, patients should be cautioned to stop use and consult a doctor if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

Patients should be encouraged to consult with a doctor or pharmacist prior to use if they are currently taking any other oral nasal decongestants or stimulants. Healthcare providers must emphasize the importance of not exceeding the recommended dosage.

Furthermore, patients should be advised to seek medical advice before using the medication if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or if they experience difficulty urinating due to an enlarged prostate gland. It is also crucial to recommend that patients consult a doctor before use 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 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 permitted, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)