Tenalif Children

Description

Tenalif Children is a pharmaceutical product identified by the National Drug Code (NDC) 69729-070-06. It is available in a liquid dosage form, packaged in a 6 fluid ounce (177 mL) container.

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 enhancing the productivity of coughs.

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. It is imperative not to exceed the directed dosage, as outlined in the Overdose warning.

For children aged 6 to under 12 years, the recommended dose is 10 mL (equivalent to 2 teaspoons) administered every 4 hours as needed. It is crucial to limit the total number of doses to a maximum of 6 doses within a 24-hour period.

For children under 6 years of age, the product is not recommended and should not be used.

Dosing should be measured exclusively with the dosing cup provided with the product. The dosing cup should not be utilized for measuring other products to ensure accurate dosing.

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.

• 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 used for depression, psychiatric or emotional conditions, or Parkinson's disease, 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 recommended.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under certain conditions. Healthcare professionals should advise patients to avoid exceeding 6 doses within a 24-hour period, as this represents the maximum daily amount. Additionally, patients should be cautioned against concurrent use with other medications containing acetaminophen and the consumption of 3 or more alcoholic drinks daily while using this product.

Acetaminophen has been associated with severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, patients must be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should be vigilant regarding patients presenting with a severe sore throat. If the sore throat persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is warranted.

Patients should be advised to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, worsening pain, nasal congestion, or cough lasting more than 7 days, fever that worsens or persists beyond 3 days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache should prompt medical evaluation, as these may indicate a serious underlying condition.

An overdose of this product can lead to significant liver damage. In cases of suspected overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center or seek medical help without delay, even if no signs or symptoms are apparent, as timely intervention is critical for both adults and children.

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 stop 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 occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition.

An overdose warning is in place, as taking more than the recommended dose can 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 for both adults and children, 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 or emotional conditions, or Parkinson's disease. Additionally, it should not be used for at least 2 weeks following the discontinuation of an MAOI to avoid potential serious 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 warranted to ensure safe use and to mitigate the risk of altered anticoagulant effects.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not be treated with this medication. For children aged 6 to under 12 years, the recommended dosage is 10 mL (or 2 teaspoons) every 4 hours. There is no established safety or efficacy for use in children under 6 years of age, and therefore, this medication is contraindicated in this population.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 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. Severe liver damage may occur if patients exceed the maximum daily amount 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.

Patients with a history of liver disease are advised to consult a healthcare professional prior to use. It is crucial for these patients to adhere strictly to the recommended dosage to avoid the risk of overdose, which may lead to liver damage. In the event of an overdose, immediate medical attention is essential. Patients should seek help or contact a Poison Control Center without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Overdosage

In the event of an overdose, defined as the ingestion of a dose exceeding the recommended amount, there is a significant risk of liver damage. This potential complication underscores the importance of prompt medical intervention.

Healthcare professionals are advised to seek immediate medical assistance or contact a Poison Control Center without delay if an overdose is suspected. Quick medical attention is crucial for both adults and children, even in instances where no signs or symptoms are immediately apparent. Early intervention can be vital in mitigating the risks associated with overdose and ensuring appropriate management of the situation.

Nonclinical Toxicology

There is no relevant information available regarding teratogenic or non-teratogenic effects. Additionally, no data has been provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen. 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 recommended that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

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 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 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 product 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 or a recurrence of cough, especially if accompanied by a rash or persistent headache, may indicate a serious condition, warranting immediate medical attention.

When using this product, patients must not exceed the recommended dose, and they should be informed of the potential risks associated with 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 using this medication. Furthermore, patients with a persistent or chronic cough, such as those caused by smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Patients should be encouraged to consult a healthcare professional if they have a cough that produces excessive phlegm (mucus).

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 is important to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not permitted, as it may compromise the integrity of the product. Healthcare professionals are advised to retain the carton for reference to the complete Drug facts.

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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)