Tukol Honey Daytime Cold and Flu

Description

Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCl are the active pharmaceutical ingredients in this formulation. The product is presented in a liquid dosage form, with a total volume of 4 fluid ounces (118 ml). It features a natural honey flavor, contributing to its sensory profile.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates minor aches and pains, headaches, sore throats, nasal congestion, and cough due to minor throat and bronchial irritation. Additionally, it temporarily reduces fever.

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

Dosage and Administration

For adults and children aged 12 years and over, the recommended dosage is 30 mL (2 tablespoons) administered every 4 hours. It is imperative that no more than 4 doses are taken within a 24-hour period to avoid potential overdose.

For children under 12 years of age, the use of this product is not recommended.

Healthcare professionals should instruct patients to measure the dosage using only the dosing cup provided with the product, ensuring that the dosing cup remains with the product for accurate measurement.

When utilizing both Day Time and Night Time formulations, it is essential to carefully read each label to confirm the correct dosing instructions for each product.

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) or within two weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease, as the combination may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription drug, a healthcare professional should be consulted.

• Use beyond the recommended dosage is contraindicated, as it may lead to overdose.

• Consumption of alcoholic beverages is not advised while using this product, due to potential interactions and increased risk of adverse effects.

Warnings and Precautions

The product contains Acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4 doses (30 mL each) within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 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.

General precautions should be observed when using this product. It is contraindicated to use with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a doctor or pharmacist is recommended. The product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuing such medications. Healthcare professionals should be consulted if there is uncertainty about the presence of an MAOI in a prescription drug.

Before using this product, individuals should seek medical advice if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, difficulty urinating due to an enlarged prostate gland, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or a cough accompanied by excessive phlegm. Additionally, consultation with a doctor or pharmacist is warranted for patients taking the anticoagulant warfarin.

While using this product, it is crucial to adhere to the recommended dosage and avoid alcoholic beverages.

In the event of an accidental overdose, immediate medical attention should be sought, or contact with a Poison Control Center is essential. Prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Users should discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if fever worsens or persists beyond 3 days; if pain or cough intensifies or lasts longer than 5 days in children or 7 days in adults; if redness or swelling occurs; if a cough recurs or is accompanied by a rash or headache that persists; or if new symptoms develop. These may indicate a serious condition requiring medical evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of this product, which is 4 doses (30 mL each) within a 24-hour period. The risk of liver damage is further increased when this product is taken in conjunction with other medications containing acetaminophen or when consumed with three or more alcoholic drinks daily.

Patients should be aware that acetaminophen may lead to severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Overdose of this product, defined as taking more than the recommended dose, poses a significant risk of liver damage. In cases of accidental overdose, patients are advised to seek medical help or contact a Poison Control Center without delay, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients are instructed to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if fever worsens or persists beyond three days, or if pain or cough intensifies or lasts longer than five days in children or seven days in adults, medical advice should be sought. The presence of redness or swelling, a returning cough, or a cough accompanied by a rash or headache that persists warrants immediate consultation. New or unusual symptoms may indicate a serious condition and should not be ignored.

Before using this product, patients with pre-existing conditions such as liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland should consult a healthcare provider. Those with persistent or chronic coughs, such as those associated with smoking, asthma, or emphysema, or coughs accompanied by excessive phlegm should also seek medical advice prior to use.

Furthermore, patients taking the anticoagulant warfarin should consult a doctor or pharmacist before using this product to avoid potential interactions.

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) for depression, psychiatric, or emotional conditions, or for Parkinson's disease. This contraindication extends for two weeks after discontinuation of the MAOI, as the combination may lead to serious adverse effects.

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 interactions that could affect bleeding risk.

Packaging & NDC

Below are the non-prescription pack sizes of Tukol Honey Daytime Cold and Flu (acetaminophen, dextromethorphan hydrobromide, 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. For patients aged 12 years and older, the recommended dosage is 30 mL (2 tablespoons) every 4 hours.

Geriatric Use

Elderly patients may have an increased sensitivity to this adult strength product, which is not intended for use in individuals under 12 years of age. It is essential for geriatric patients to consult a healthcare provider prior to use, particularly if they have pre-existing conditions such as liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or urinary difficulties due to an enlarged prostate gland.

When administering this product to elderly patients, it is crucial to adhere strictly to the recommended dosage and to avoid the consumption of alcoholic beverages, as these factors may exacerbate potential side effects. Geriatric patients should be closely monitored for any adverse reactions, including symptoms such as nervousness, dizziness, or insomnia. If any of these symptoms occur, or if fever worsens or persists beyond three days, or if pain or cough intensifies or lasts longer than seven days, it is imperative to discontinue use and seek medical advice.

Additionally, prompt medical attention is vital for elderly patients in the event of an accidental overdose, as the consequences may be more severe in this population. Careful consideration and monitoring are advised to ensure the safe use of this product among geriatric patients.

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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 medication 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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 exercise caution when using this product, which contains Acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 4 doses (30 mL each) within a 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

It is advised that patients with a history of liver disease consult a healthcare professional prior to use. During treatment, patients should avoid the consumption of alcoholic beverages to minimize the risk of liver injury.

In the event of an accidental overdose, which may lead to liver damage, it is imperative that patients seek immediate medical assistance or contact a Poison Control Center. Prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are present.

Overdosage

In the event of an overdose, the potential for liver damage increases significantly when the recommended dose is exceeded. It is imperative that healthcare professionals remain vigilant regarding the signs and symptoms associated with overdosage, as these may not always be immediately apparent.

In cases of accidental overdose, it is crucial to seek medical assistance without delay. Healthcare providers should advise patients or caregivers to contact a Poison Control Center or seek emergency medical help immediately. Prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms, to mitigate the risk of serious complications.

Healthcare professionals are encouraged to monitor patients closely and provide appropriate management based on the severity of the overdose and the clinical presentation.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with the use of acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. Reports of these adverse reactions have been received voluntarily and through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed 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 be encouraged to consult a doctor or pharmacist.

It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the last two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and consult a doctor if their fever worsens or persists for more than three days. If pain or cough worsens or lasts longer than five days in children or seven days in adults, patients should also seek medical attention. They should be made aware that the presence of redness or swelling warrants a consultation with a healthcare provider.

Patients should be informed to stop use and contact a doctor if a cough returns or occurs alongside a rash or persistent headache. They should also be advised to seek medical attention if new symptoms arise, as these may indicate a serious condition.

When using this product, patients must be cautioned not to exceed the recommended dosage and to avoid alcoholic beverages. It is essential for patients to consult a doctor before using this product if they have any of the following conditions: liver disease, heart disease, thyroid disease, diabetes, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice before use. Furthermore, patients should be advised to consult a doctor if they have a cough accompanied by excessive phlegm (mucus) or if they are taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. 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 should be observed to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)