Tenalif Multi Symptom Relief

Description

Tenalif Multi Symptom Relief is available in a dosage form of a liquid solution, packaged in a 6 fluid ounce (177 mL) container. The product is identified by the National Drug Code (NDC) 69729-051-06.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates 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 promotes nasal and/or sinus drainage and assists in loosening phlegm (mucus) and thinning 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

Patients should adhere strictly to the recommended dosage and administration guidelines. The maximum dosage should not exceed 6 doses within a 24-hour period. It is imperative to measure the dose using only the dosing cup provided with the product; the dosing cup should not be utilized for any other products to ensure accurate dosing.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered every 4 hours as needed. For children under 12 years of age, the use of this product is not recommended.

Healthcare professionals should counsel patients to avoid exceeding the directed dosage and to consult a physician if there are any uncertainties regarding the appropriate use of the product.

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. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 doses within a 24-hour period (the maximum daily amount for this product), 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 a skin reaction, it is imperative to discontinue use immediately and seek medical assistance. Additionally, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a healthcare provider is advised.

General precautions must be observed to ensure safe use of this product. The recommended dose should not be exceeded, and individuals should consult a healthcare professional prior to use 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 (such as from smoking, asthma, chronic bronchitis, or emphysema). Furthermore, individuals with a cough that produces excessive phlegm should also seek medical advice before use.

Patients taking the anticoagulant warfarin or those on a sodium-restricted diet should consult a doctor or pharmacist before using this product.

In the event of an overdose, immediate medical attention is crucial. Individuals should contact a Poison Control Center or seek emergency medical help right away, as timely intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Users should discontinue use and consult a 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 or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires medical 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.

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 lasts more than three days; if redness or swelling is present; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that persists. These symptoms may indicate a serious condition.

An overdose warning is in place, 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 for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Concurrent use 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 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 serious interactions.

Patients taking the anticoagulant warfarin should consult 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 Multi Symptom Relief (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 use this medication. For adolescents and adults aged 12 years and older, the recommended dosage is 20 mL administered in the dosing cup provided every 4 hours. Caution is advised when considering the use of this medication in pediatric populations, as safety and efficacy have not been established in children under the age of 12.

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 potential 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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 absence of 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. Severe liver damage may occur if patients exceed 6 doses within a 24-hour period, which is the maximum daily amount for this product. Additionally, the risk of liver damage increases if acetaminophen 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 if an overdose is suspected. Quick medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Early intervention can be vital in mitigating the risks associated with overdose and ensuring appropriate management.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

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 check with a healthcare professional 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 a rash or persistent headache, may indicate a serious condition, and they should seek 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 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. Users 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 Multi Symptom Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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