Tukol Max Action Cold, Flu and Sore Throat

Description

Tukol® MAX ACTION is a pharmaceutical formulation indicated for the relief of symptoms associated with cold, flu, and sore throat. The product contains a combination of active ingredients: acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride. It is designed for use in individuals aged 12 years and older.

The formulation is provided in a liquid dosage form, with a total volume of 6 fluid ounces (177 mL). Tukol® MAX ACTION is specifically formulated to alleviate minor aches and pains, reduce fever, relieve nasal and chest congestion, and suppress cough.

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 reduction. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the expulsion of mucus and enhancing the productivity of coughs.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. The adult strength product is intended for use in adults and children aged 12 years and older. The recommended dose for this population is 20 mL every 4 hours, not to exceed 4 doses within a 24-hour period.

It is imperative that patients do not exceed the directed dosage. For accurate measurement, the dose cup provided should be utilized. This product is not suitable for children under 12 years of age; therefore, its use in this demographic is contraindicated.

Healthcare professionals should ensure that patients are informed of these guidelines to promote safe and effective use of the medication.

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. Additionally, use is prohibited for 2 weeks following the discontinuation of an MAOI. Patients should verify with a healthcare professional if their prescription medications contain an MAOI prior to using this product.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage is exceeded. Specifically, liver damage may occur if more than 4 doses (20 mL each) are taken within a 24-hour period, if it is used concurrently with other medications containing acetaminophen, or if consumed with 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

Healthcare professionals should exercise caution and advise patients to consult a doctor prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, chronic respiratory issues (such as chronic bronchitis), persistent cough (especially 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 anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product. It is essential that patients adhere strictly to the recommended dosage and not exceed the directed amount.

In the event of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent.

Patients are advised to discontinue use and consult a healthcare provider if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 7 days; recurrence of cough accompanied by fever, rash, or persistent headache; fever that worsens or lasts more than 3 days; presence of redness or swelling; or the emergence of new symptoms. These signs may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 20 mL (4 doses) within a 24-hour period, particularly when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily. Patients should be aware that acetaminophen can lead to severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of such a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Additionally, it is contraindicated for patients taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the cessation of an MAOI. Patients uncertain about the presence of acetaminophen or MAOIs in their medications should consult a doctor or pharmacist.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, chronic respiratory issues, or those experiencing persistent coughs should seek medical advice before using this product. Furthermore, individuals taking the anticoagulant warfarin should also consult a healthcare professional prior to use.

Patients are advised to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if a cough recurs with fever, rash, or a lasting headache, medical attention should be sought. A worsening fever lasting more than three days, the presence of redness or swelling, or the emergence of new symptoms may indicate a serious condition requiring prompt evaluation.

It is critical to note that taking more than the recommended dose can lead to overdose and potential liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately, as timely medical intervention is essential, even in the absence of noticeable signs or symptoms.

Drug Interactions

Concurrent use of this product with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's disease should avoid using this product. This contraindication extends for a period of two weeks following the discontinuation of the MAOI to prevent serious adverse effects.

Additionally, individuals on the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this product. Monitoring of coagulation parameters may be warranted to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Tukol Max Action Cold, Flu and Sore Throat (acetaminophen, 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. For children under this age, use is contraindicated.

For adolescents aged 12 years and older, the recommended dosage is 20 mL every 4 hours as needed.

Geriatric Use

Elderly patients, particularly those aged 65 and older, should exercise caution when using this adult strength product, which is not intended for use in children under 12 years of age. Prior to use, it is advisable for geriatric patients to consult a healthcare provider if they have a history of liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or respiratory conditions such as chronic bronchitis, asthma, or emphysema. Additionally, those experiencing persistent coughs, especially those associated with excessive phlegm, or difficulties urinating due to an enlarged prostate gland should seek medical advice.

Furthermore, geriatric patients who are currently taking the anticoagulant medication warfarin should consult with a doctor or pharmacist before using this product to ensure safety and avoid potential drug interactions. Monitoring and appropriate dose modifications may be necessary based on individual health status and concurrent medications.

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 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 absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is essential for these patients to consult a healthcare professional prior to use, particularly if they have a history of liver disease.

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

Patients with compromised liver function must be vigilant about adhering to the recommended dosage to avoid overdose, which can lead to significant liver damage. In the event of an overdose, it is critical to seek immediate medical attention or contact a Poison Control Center, even if no signs or symptoms are present, as prompt intervention is vital.

Overdosage

In cases of overdose, the administration of doses exceeding the recommended amount may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential consequences of such an event.

Immediate medical assistance is crucial in the event of an overdose. Healthcare providers should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay. This prompt action is essential, even in the absence of noticeable signs or symptoms, as early intervention can mitigate the risk of severe complications.

Healthcare professionals should monitor patients closely for any signs of liver impairment and initiate appropriate management procedures as necessary.

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

There have been reports of severe skin reactions associated with acetaminophen, including symptoms such as skin reddening, blisters, and rash. In cases where a skin reaction occurs, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. It is important to emphasize 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 instructed to use this product strictly as directed and not exceed the recommended dosage. Additionally, healthcare providers should encourage patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, a breathing problem such as chronic bronchitis, a persistent or chronic cough (including those associated with smoking, asthma, chronic bronchitis, or emphysema), a cough that produces excessive phlegm, or difficulty urinating due to an enlarged prostate gland.

Furthermore, patients should be advised to speak with a doctor or pharmacist prior to use if they are currently taking the blood-thinning medication warfarin, to ensure safe and effective use of the 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

The medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years of age. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use.

Patients should be informed to keep the medication out of reach of children and to adhere strictly to the recommended dosage, as exceeding this may lead to liver damage. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately, even if no symptoms are present.

Drug Information (PDF)

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

View product document (PDF)