Tukol Honey Nighttime Cold and Flu

Description

Night Time Tukol® HONEY MULTISYMPTOM COLD & FLU is a combination medication formulated for individuals aged 12 years and older. It contains acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate as active ingredients. The product is presented in a liquid dosage form with a natural honey flavor. Each bottle contains 4 fluid ounces (118 ml) of the formulation.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including sore throat, headache, minor aches and pains, runny nose, sneezing, and cough due to minor throat and bronchial irritation. Additionally, it temporarily reduces fever associated with these conditions.

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

Dosage and Administration

Healthcare professionals should advise patients to 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.

For adults and children aged 12 years and over, the recommended dose is 30 mL (equivalent to 2 tablespoons) every 6 hours. Patients should not exceed 4 doses within a 24-hour period. It is imperative that the dosing cup provided with the product is used for accurate measurement, and this cup should be kept with the product at all times.

This product is not intended for use in children under 12 years of age. When utilizing both daytime and nighttime formulations, it is essential to carefully read each label to ensure correct dosing and avoid potential overdosing.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

• Administration for more than 10 days for pain, or more than 3 days for fever, unless directed by a healthcare professional, to prevent potential adverse effects from prolonged use.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions.

• For the purpose of inducing sleepiness in children, as this is not an approved indication and may pose safety risks.

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) 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 any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Exceeding the recommended dosage can result in serious health complications. In cases of overdose, immediate medical attention is essential; patients should contact a Poison Control Center without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

General precautions should be taken prior to use. Patients should be advised to consult a healthcare provider if they have any of the following conditions: liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems or chronic cough related to smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate gland. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Patients should be instructed to stop taking the product and contact their doctor if they experience redness or swelling, if symptoms do not improve within 7 days or are accompanied by fever, if fever worsens or persists for more than 3 days, if new symptoms arise, or if a cough lasts more than 7 days, recurs, or occurs with fever, rash, or headache. These symptoms may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 4 doses (30 mL) within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

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

Patients should also discontinue use and consult a doctor if they experience redness or swelling, if symptoms do not improve within seven days or are accompanied by fever, if fever worsens or lasts more than three days, if new symptoms arise, or if a cough persists for more than seven days, recurs, or occurs with fever, rash, or headache. These symptoms may indicate a serious condition.

Additional adverse reactions may include excitability, particularly in children, and marked drowsiness. Patients are cautioned to exercise care when driving a motor vehicle or operating machinery, as alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

The use of this medication is not recommended in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson's disease, and their interaction with this medication may lead to serious adverse effects.

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking sedatives or tranquilizers, as these substances may enhance the sedative effects, leading to increased drowsiness.

Additionally, individuals on the anticoagulant warfarin should seek advice from a healthcare provider before using this medication, as potential interactions may affect anticoagulation control.

It is important to note that the concomitant use of alcohol, sedatives, and tranquilizers with this medication may further increase drowsiness, necessitating caution in activities requiring alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Tukol Honey Nighttime Cold and Flu (acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. The recommended dosage for adults and children aged 12 years and older is 30 mL (2 tablespoons) every 6 hours. Caution should be exercised when considering the use of this product in younger populations, as safety and efficacy have not been established in children under 12.

Geriatric Use

Elderly patients may experience marked drowsiness when using this product, necessitating caution when driving a motor vehicle or operating machinery. The potential for increased drowsiness is further heightened in the presence of alcohol, sedatives, or tranquilizers.

It is important for healthcare providers to inquire about any underlying liver disease in geriatric patients prior to recommending this product, as such conditions may necessitate additional considerations or adjustments in use.

This product is not intended for use in children under 12 years of age, and its safety and efficacy in geriatric patients should be carefully monitored, particularly due to the increased risk of adverse effects.

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 healthcare 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

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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) within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

It is recommended that patients with a history of liver disease consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in these patients to detect any potential adverse effects early.

Overdosage

Taking more than the recommended dose of the medication may lead to serious health complications. It is imperative that healthcare professionals remain vigilant regarding the potential risks associated with overdosage.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center without delay. Prompt intervention is crucial, as the onset of symptoms may not be immediately apparent. This applies to both adults and children, underscoring the importance of acting swiftly even in the absence of noticeable signs or symptoms.

Healthcare professionals should ensure that patients and caregivers are aware of the critical nature of seeking medical help in cases of suspected overdose, reinforcing the need for vigilance and timely action.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately and medical assistance be sought. Additional adverse reactions may occur; however, specific details regarding these reactions are not provided in the available data.

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.

Patients should be informed not to use this medication for more than 10 days for pain or more than 3 days for fever unless directed by a healthcare professional. It is important to caution patients against using 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 advised to seek clarification from a healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be warned not to use this medication to induce sleepiness in children. They should be instructed to stop use and consult a doctor if they experience redness or swelling, if symptoms do not improve within 7 days, or if symptoms are accompanied by a fever. Additionally, patients should be advised to seek medical attention if a fever worsens or persists beyond 3 days, or if new symptoms arise.

If a cough lasts more than 7 days, recurs, or occurs with fever, rash, or a persistent headache, patients should be advised to stop use and consult a healthcare provider, as these may indicate a serious condition. While using this product, patients should be reminded to adhere strictly to the recommended dosage and to avoid alcoholic beverages, as alcohol can exacerbate drowsiness.

Patients should be informed that excitability may occur, particularly in children, and that marked drowsiness may also be a side effect. Caution should be exercised when driving or operating machinery while using this product. Patients should be made aware that the combination of this medication with alcohol, sedatives, or tranquilizers may increase drowsiness.

Before using this product, patients should be encouraged to consult a healthcare provider if they have liver disease, glaucoma, a cough associated with excessive phlegm, or any breathing problems, including chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema. Patients experiencing difficulty urinating due to an enlarged prostate gland should also seek medical advice prior to use. Furthermore, patients taking sedatives, tranquilizers, or the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

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 health professional prior to use. Additionally, patients should be instructed to seek medical advice before using the medication if they have liver disease, glaucoma, a cough associated with excessive phlegm, breathing problems, chronic cough related to smoking, asthma, chronic bronchitis, emphysema, or difficulty urinating due to an enlarged prostate gland. It is also important for patients to consult a doctor or pharmacist if they are taking sedatives, tranquilizers, or the blood-thinning medication warfarin.

Drug Information (PDF)

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

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