Tukol Multi Symptom Cold

Description

Tukol® is a combination product containing dextromethorphan HBr, guaifenesin, and phenylephrine HCl, classified as an expectorant, cough suppressant, and nasal decongestant. It is indicated for the relief of cough, the thinning and loosening of phlegm, and the clearing of nasal congestion. This formulation is suitable for individuals aged 12 years and older. The product is available in a volume of 4 fluid ounces (118 mL) and is distributed by Genomma Lab USA Inc., located in Houston, TX 77027.

Uses and Indications

This drug is indicated for the relief of symptoms associated with respiratory conditions. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating drainage of the bronchial tubes. Additionally, it temporarily alleviates symptoms occurring with a cold, including nasal congestion and cough due to minor throat and bronchial irritation.

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 2 teaspoons every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period to avoid potential overdose.

This product is not intended for use in children under 12 years of age. Healthcare professionals should ensure that this guideline is strictly followed to maintain patient safety and efficacy of treatment.

Contraindications

There are no explicit contraindications identified for this product. However, it is advised that the product should not be used in excess of the directed dosage.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for a minimum of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

Patients are instructed to discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within seven days or are accompanied by fever, or if a cough persists beyond seven days, recurs, or is associated with fever, rash, or a persistent headache, patients should be evaluated for potential serious conditions.

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 product. Serious adverse reactions may occur, particularly in individuals with specific pre-existing conditions. It is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or for those who have discontinued MAOI therapy within the past two weeks.

Common adverse reactions include nervousness, dizziness, and sleeplessness. Patients are advised to discontinue use and consult a healthcare professional if these symptoms occur. Additionally, if symptoms do not improve within seven days, or if they are accompanied by fever, patients should seek medical advice. A persistent cough lasting more than seven days, or one that recurs with fever, rash, or a persistent headache, also warrants consultation with a healthcare provider.

Before using this product, patients should inform their 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. Coughs associated with excessive phlegm or chronic conditions such as smoking, asthma, chronic bronchitis, or emphysema should also be discussed with a healthcare professional prior to use.

Furthermore, patients should consult a doctor or pharmacist if they are taking any other oral nasal decongestants or stimulants. It is crucial to adhere to the recommended dosage and not exceed the directed use of this product to minimize the risk of adverse reactions.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this product while taking MAOIs or for a period of two weeks following the discontinuation of an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Patients uncertain about whether their prescription includes an MAOI are advised to consult a healthcare professional prior to using this product.

Additionally, it is recommended that patients seek guidance from a healthcare provider 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 Multi Symptom Cold (dextromethorphan hydrobromide, guaifenesin, 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 patients aged 12 years and older, the recommended dosage is 2 teaspoons every 4 hours. There are no established dosing guidelines for children under 12, and use in this population is not advised.

Geriatric Use

Elderly patients may require careful consideration when using this adult strength product, which is not intended for use in children under 12 years of age. For adults and children aged 12 years and older, the recommended dosage is 2 teaspoons every 4 hours.

It is important for healthcare providers to monitor geriatric patients closely for any potential adverse effects, as age-related physiological changes may affect drug metabolism and clearance. Dose adjustments may be necessary based on individual patient response and tolerance. Caution is advised when prescribing this medication to elderly patients, particularly those with comorbidities or those taking multiple medications, to minimize the risk of drug interactions and side effects.

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 known. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

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 mothers.

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

Overdosage may lead to serious adverse effects that can significantly impact patient health. It is imperative that healthcare professionals recognize the potential severity of an overdose and act promptly.

In the event of an overdose, immediate medical attention is essential. Healthcare providers should ensure that patients receive appropriate evaluation and management to mitigate the risks associated with overdosage. This may include supportive care and symptomatic treatment as necessary, depending on the specific circumstances and the substance involved.

Monitoring for symptoms of overdosage is crucial, as these can vary widely and may include a range of physiological and psychological manifestations. Prompt identification and intervention can be critical in preventing further complications and ensuring patient safety.

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 the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. These reactions may occur in patients using the product.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, patients should seek medical advice. It is also important to instruct patients to stop use and consult a doctor if a cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

Before using this product, patients should be encouraged to consult a doctor if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or those with chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema should also seek medical advice prior to use.

Furthermore, patients should be advised to consult a doctor or pharmacist if they are currently taking any other oral nasal decongestants or stimulants. It is essential to remind patients to adhere to the recommended dosage and not exceed the directed amount while using this product.

Storage and Handling

The product is supplied with a dosage cup included for accurate measurement. It should be stored at a temperature range of 20‐25 °C (68‐77 °F). It is important to note that refrigeration is not recommended for this product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)