Tesalon Children

Description

Tesalon® is a pharmaceutical formulation indicated for the relief of symptoms associated with cold, flu, and sore throat in pediatric patients. Each dosage form contains a combination of active ingredients: acetaminophen for the alleviation of headache and fever, dextromethorphan HBr for cough control, guaifenesin to thin and loosen mucus, and phenylephrine HCl to relieve nasal congestion. The product is available in a maximum strength formulation, providing relief for up to 8 hours. The product is packaged in a box containing a 6 FL OZ (177 mL) bottle and a measuring cup for accurate dosing. The National Drug Code (NDC) for this product is 69729-786-06.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including sinus congestion and pressure, minor aches and pains, nasal congestion, cough due to minor throat and bronchial irritation, sore throat, headache, and fever. Additionally, it temporarily promotes nasal and/or sinus drainage and helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of bothersome mucus and making coughs more productive.

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 maximum dosage should not exceed the specified limits, and patients should be cautioned against taking more than six doses within a 24-hour period.

Dosing should be measured exclusively with the dosing cup provided, and this cup should not be used for measuring other products to ensure accuracy.

For children aged 6 to under 12 years, the recommended dose is 10 mL (equivalent to 2 teaspoons) administered every 4 hours as needed, or as directed by a physician. It is important to note that this product is not recommended for children under 6 years of age.

Healthcare professionals should ensure that patients understand these guidelines to prevent misuse and potential overdose.

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. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• 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. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Additionally, it is essential to adhere to the recommended dosage to avoid the risk of overdose.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage 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 consumed with three or more alcoholic drinks daily. Healthcare professionals should be vigilant regarding the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use and seek immediate medical assistance.

Patients presenting with a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be advised to consult a physician promptly. Overdosing on acetaminophen can lead to liver damage; therefore, in the event of an overdose, immediate medical help or contact with a Poison Control Center is essential, even if the patient does not exhibit any signs or symptoms.

General precautions should be taken prior to use. Patients should be advised to consult a healthcare provider if they have a history of liver disease, heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Additionally, those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or a cough that produces excessive phlegm should seek medical advice before use. It is also recommended that patients taking the anticoagulant warfarin or those on a sodium-restricted diet consult with a doctor or pharmacist prior to use.

Patients should be instructed to stop taking the product and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 7 days; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs with fever, rash, or headache that lasts. These symptoms may indicate a serious condition requiring further evaluation.

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.

Patients are advised to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever intensifies or lasts more than three days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs with fever, rash, or headache that lasts are also indicators of a potentially serious condition requiring medical evaluation.

An overdose warning is pertinent, as taking more than the recommended dose may lead to liver damage. In cases of suspected 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 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) for the treatment of depression, psychiatric disorders, or Parkinson’s disease, as well as for a period of two weeks following the discontinuation of an MAOI. The combination may lead to serious and potentially life-threatening interactions.

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 avoid potential alterations in anticoagulant effect.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should not use this medication. For children aged 6 to under 12 years, the recommended dosage is 10 mL (2 teaspoonfuls) every 4 hours, with a maximum of 6 doses in a 24-hour period.

Healthcare professionals should advise parents or guardians to consult a doctor prior to use if the child has any of the following conditions: liver disease, heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Additionally, if a child experiences a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt medical consultation is recommended.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 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. It is important to note that severe liver damage may occur if patients exceed 6 doses within a 24-hour period, which is the maximum daily amount. 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.

Patients with a history of liver disease are advised to consult a healthcare professional prior to use. It is critical to adhere to the recommended dosage, as taking more than the prescribed amount may lead to overdose and subsequent liver damage. In the event of an overdose, immediate medical attention is essential, and patients should contact a Poison Control Center without delay, even if no signs or symptoms are present. Quick medical intervention is vital to mitigate potential harm.

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 nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No specific postmarketing experience details are provided in the insert.

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 medication contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that this product is not recommended for use in children under 12 years of age. Additionally, patients should be cautioned against using this medication 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 check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. They should also be advised to stop using the product and consult a doctor 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 or a recurrence of cough, especially if accompanied by fever, rash, or a persistent headache, may indicate a serious condition requiring medical attention.

When using this product, patients must be reminded not to exceed the recommended dose, as this could lead to overdose. Patients with liver disease, heart disease, diabetes, thyroid disease, high blood pressure, or those experiencing difficulty urinating due to an enlarged prostate gland should be advised to consult a doctor before use. Furthermore, patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to using this medication. Patients should also be encouraged to consult a healthcare provider if they have a cough that produces excessive phlegm.

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 product.

Storage and Handling

The product is supplied in a carton that contains essential Drug Facts. It should be stored at a temperature range of 20-25°C (68-77°F). It is important to avoid refrigeration to maintain the integrity of the product. The carton should be retained for reference to the complete Drug Facts.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 10 mL (or 2 teaspoons) every 4 hours for children aged 6 to under 12 years, using the dosing cup provided. Clinicians should advise patients to consult a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Tesalon Children, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)