Tesalon Jarabe Adulto

Description

Tesalon® (NDC 69729-787-06) is a multi-symptom relief formulation indicated for the treatment of cold, flu, and sore throat symptoms. This maximum strength product provides relief from fever and headache through the action of acetaminophen, while dextromethorphan HBr serves as a cough suppressant. Guaifenesin is included to thin and expel mucus, and phenylephrine HCl is utilized to alleviate nasal congestion. The formulation offers relief for up to 8 hours. Each package contains a 6 FL OZ (177 mL) bottle and a dosing cup. The product features a tamper-evident seal; it should not be used if the printed safety seal around or under the cap is broken or missing. A Spanish version of the labeling is included inside the box.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and flu. Specifically, it alleviates sinus congestion and pressure, minor aches and pains, nasal congestion, cough due to minor throat and bronchial irritation, sore throat, and headache. Additionally, it temporarily reduces fever, promotes nasal and/or sinus drainage, and helps to loosen phlegm (mucus) and thin bronchial secretions, thereby facilitating the expulsion of bothersome mucus and enhancing the productivity of coughs.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 20 mL, measured using the dosing cup provided, every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period. The dosing cup must only be used for this product and should not be utilized with any other products to ensure accurate measurement.

For children under 12 years of age, the use of this product is not recommended. Healthcare professionals should advise patients to adhere strictly to the dosing instructions and to avoid exceeding the recommended dosage, as outlined in the Overdose warning.

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.

• In children under 12 years of age, as safety and efficacy have not been established in this population.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, due to the potential for serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Warnings and Precautions

This product contains acetaminophen, which poses significant risks if not used according to guidelines. Severe liver damage may occur if the maximum daily dosage of 6 doses within 24 hours is exceeded, if it is taken concurrently with other medications containing acetaminophen, or if the user consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen is also associated with the potential for severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

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

Overdose of acetaminophen can lead to liver damage. In the event of an overdose, immediate medical help should be sought, or the Poison Control Center should be contacted without delay. Quick medical attention is critical, even if the patient does not exhibit any signs or symptoms of overdose.

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, heart disease, diabetes, thyroid disease, high blood pressure, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should seek guidance from a doctor or pharmacist if they are taking the blood-thinning medication warfarin or are on a sodium-restricted diet.

Patients should be instructed to stop taking the product and contact their doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists for more than 7 days; if fever worsens or lasts more than 3 days; if redness or swelling is present; if new symptoms arise; or if a cough recurs or occurs with fever, rash, or headache that lasts, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of six doses 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 where a sore throat is severe, 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 nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than seven days; if fever worsens or persists for more than three days; if redness or swelling is observed; if new symptoms arise; or if a cough recurs with fever, rash, or headache that lasts. These symptoms may indicate a serious condition.

An overdose of this product, defined as taking more than the recommended dose, may lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential even if no signs or symptoms are initially apparent.

Drug Interactions

Concurrent use of this medication with other products 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), which includes certain medications prescribed for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it should not be administered for at least two weeks following the discontinuation of an MAOI to avoid potential hypertensive crises or other serious adverse effects.

Patients taking the anticoagulant warfarin should consult with 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 mitigate the risk of increased bleeding.

Packaging & NDC

Below are the non-prescription pack sizes of Tesalon Jarabe Adulto (acetaminophen, dextromethorphan hbr, guaifenesin usp, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this population, and use in this age group is contraindicated.

Geriatric Use

There is no specific information regarding the use of Tesalon Jarabe Adulto in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population, given the general considerations for pharmacotherapy in older adults.

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 considered in these populations to ensure maternal and fetal safety.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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. 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. 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 6 doses 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.

In the event of an overdose, which may result from taking more than the recommended dose, patients must seek immediate medical attention or contact a Poison Control Center. Prompt medical intervention is crucial, even if no signs or symptoms of overdose are apparent. Monitoring of liver function may be warranted in patients with compromised liver function to prevent potential adverse effects.

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 for serious adverse effects associated with overdosage.

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 indications of liver impairment and initiate appropriate management protocols as necessary.

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 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 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 this medication is not recommended for children under 12 years of age. Additionally, patients should be cautioned 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 professional if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also be advised to stop using the medication and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than 7 days, if fever worsens or lasts more than 3 days, or if any redness or swelling occurs. Patients should be made aware that new symptoms may warrant medical consultation.

Furthermore, patients should be informed to seek medical advice if a cough returns or occurs alongside fever, rash, or a headache that lasts, as these may indicate a serious condition.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have any of the following conditions: liver disease, heart disease, diabetes, thyroid disease, 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, chronic bronchitis, or emphysema, should also be advised to seek medical guidance prior to use. Additionally, patients with a cough that produces excessive phlegm should consult a healthcare professional before using this product.

Lastly, patients taking the blood-thinning medication warfarin or those on a sodium-restricted diet should be advised to consult a doctor or pharmacist before using this medication.

Storage and Handling

The product is supplied in a carton that contains essential Drug Facts. It is important to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as the product should not be exposed to lower temperatures. For optimal use and reference, the carton should be retained.

Additional Clinical Information

The medication is administered orally, with a recommended dose of 20 mL in the provided dosing cup every 4 hours for adults and children aged 12 years and older. 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 Tesalon Jarabe Adulto, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)