Tukol Max Action Cold, Sore Throat and Cough

Description

Tukol® MAX ACTION is a liquid formulation containing the active ingredients acetaminophen, dextromethorphan HBr, guaifenesin, and phenylephrine HCl. This product is indicated for the relief of minor aches and pains, fever, nasal and chest congestion, and cough. It is suitable for use in individuals aged 12 years and older. The product is supplied in a volume of 6 fluid ounces (177 mL) and is distributed by Genomma Lab USA, Inc., located in Houston, TX 77098.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including nasal congestion, cough, minor aches and pains, sore throat, headache, and fever. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the expulsion of bothersome mucus and enhancing cough productivity.

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 20 mL every 4 hours, not to exceed 4 doses within a 24-hour period. It is imperative that the dosing cup provided with the product is used for accurate measurement; the dosing cup should be kept with the product at all times.

This product is not intended for use in children under 12 years of age. Healthcare professionals should advise patients to adhere strictly to the recommended dosage and to avoid exceeding the maximum daily limit.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for 2 weeks following the discontinuation of an MAOI. If there is uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to using this product.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the recommended dosage, which is a maximum of 4 doses (20 mL each) within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications that contain acetaminophen or if they consume three or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. If any of these symptoms occur, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

Patients should be instructed to stop use and seek medical advice 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 recurs or occurs with fever, rash, or persistent headache, medical consultation is necessary. Patients should also be vigilant for worsening fever lasting more than three days, the presence of redness or swelling, or the emergence of new symptoms, as these may indicate a serious condition.

In the event of an overdose, immediate medical attention is critical. Patients should be advised to contact a Poison Control Center or seek emergency medical help, even if no signs or symptoms are immediately apparent.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed the maximum daily dosage of 4 doses (20 mL each) within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a doctor promptly.

Patients should stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness; if symptoms do not improve within 7 days or are accompanied by fever; if a cough recurs or occurs with fever, rash, or persistent headache; if fever worsens or lasts more than 3 days; if redness or swelling is present; or if new symptoms arise, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, breathing problems such as chronic bronchitis, persistent or chronic cough (including that associated with smoking, asthma, chronic bronchitis, or emphysema), cough with excessive phlegm, or difficulty urinating due to an enlarged prostate gland.

Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

Concurrent use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Co-administration may lead to serious and potentially life-threatening interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be necessary to ensure safe use and to avoid potential alterations in the effectiveness of warfarin.

Packaging & NDC

Below are the non-prescription pack sizes of Tukol Max Action Cold, Sore Throat and Cough (acetaminophen, 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. For patients aged 12 years and older, the recommended dosage is 20 mL every 4 hours. Caution is advised, as the safety and efficacy of this product have not been established in children under 12 years.

Geriatric Use

Elderly patients may require special 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 overall health status of geriatric patients prior to administration, particularly in those aged 65 and older.

Patients with a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or respiratory conditions such as chronic bronchitis, asthma, or emphysema should consult a healthcare professional before use. Additionally, those experiencing persistent coughs, especially those associated with excessive phlegm, or difficulties urinating due to an enlarged prostate gland should seek medical advice prior to starting treatment.

Furthermore, elderly patients who are currently taking the anticoagulant medication warfarin should also consult with a doctor or pharmacist before using this product, as potential interactions may necessitate careful monitoring or dosage adjustments. It is crucial to ensure the safety and efficacy of treatment in this population, given their unique health considerations.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to 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 discuss their individual circumstances with a healthcare provider to weigh the benefits and risks associated with the use of this medication 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 regarding 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance 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 should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 4 doses (20 mL each) within a 24-hour period. Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen, as this may further increase the risk of liver damage.

It is also important for patients with compromised liver function to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks daily while using this product may significantly heighten the risk of severe liver injury. Therefore, careful consideration of liver function and adherence to recommended dosage guidelines is essential for patients with hepatic impairment. Regular monitoring of liver function tests may be warranted to ensure patient safety.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient exceeds the maximum daily dosage of 4 doses (20 mL each) within a 24-hour period. This threshold represents the upper limit for safe consumption of the product.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk of severe liver damage. It is crucial for healthcare providers to evaluate a patient's medication history to prevent potential interactions that could exacerbate liver toxicity.

Alcohol Consumption Considerations Patients who consume three or more alcoholic drinks daily while using this product are also at an increased risk for severe liver damage. Healthcare professionals should counsel patients on the dangers of alcohol consumption during treatment and consider monitoring liver function in those who may be at risk.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should assess the patient's clinical status and consider appropriate interventions, which may include supportive care and monitoring of liver function tests. Prompt recognition and management of overdosage are essential to mitigate the risk of severe hepatic injury.

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

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial even if no signs or symptoms are present.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be advised to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should seek medical advice if their symptoms do not improve within seven days or are accompanied by fever. Patients should also be instructed to stop use and contact a healthcare provider if a cough returns or occurs with fever, rash, or persistent headache, or if fever worsens or lasts more than three days. Any signs of redness or swelling, as well as the emergence of new symptoms, should prompt patients to seek medical attention, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the directed dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or breathing problems such as chronic bronchitis. Patients with a persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Furthermore, patients experiencing a cough with excessive phlegm or those who have difficulty urinating due to an enlarged prostate gland should consult a healthcare provider. Lastly, patients taking the blood-thinning medication warfarin should be advised to speak with their doctor or pharmacist before using this product.

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

No further data are available.

Drug Information (PDF)

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

View product document (PDF)