Extra Strength Tylenol Severe Cough Plus Sore Throat Day

Description

This formulation is identified by NDC 50580-446-01 and is marketed under the brand name TYLENOL® EXTRA STRENGTH. It is intended for adult use and is indicated for the relief of severe cough accompanied by sore throat. Each dosage unit contains Acetaminophen, which serves as a pain reliever and fever reducer, and Dextromethorphan HBr, which acts as a cough suppressant. The product is supplied in a package containing 24 caplets.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, headache, sore throat, and cough. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 2 caplets every 6 hours as needed while symptoms persist. The maximum dosage should not exceed 6 caplets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, the use of this medication should not extend beyond 10 days unless specifically advised by a doctor.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, a healthcare professional should be consulted.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may result in severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

Consultation Prior to Use Healthcare professionals should advise patients to consult a doctor before using this product if they have liver disease, a persistent or chronic cough associated with smoking, asthma, or emphysema, or a cough that produces excessive phlegm. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist prior to use.

Dosage Compliance Patients must adhere strictly to the recommended dosage and should not exceed it while using this product.

Emergency Medical Assistance In the event of an overdose, immediate medical attention is essential. Patients should contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Discontinuation of Use Patients should stop using this product and consult a doctor if any of the following occur: worsening pain or cough lasting more than 7 days; fever that worsens or persists for more than 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, including serious warnings related to liver health and allergic reactions.

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen within a 24-hour period, use this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should stop using the product and consult a healthcare professional if pain or cough worsens or persists beyond 7 days, if fever worsens or lasts more than 3 days, if redness or swelling is observed, if new symptoms arise, or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Before using this product, patients with liver disease, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or cough accompanied by excessive phlegm should consult a healthcare provider.

It is also important to avoid using this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients should refrain from using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks, as well as if they have a history of allergic reactions to this product or any of its ingredients.

Patients taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use. In the event of an overdose, immediate medical attention is crucial; patients should contact a Poison Control Center or seek medical help right away, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

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 two weeks following the discontinuation of an MAOI, as this may lead to 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 warranted to ensure safe use and to mitigate the risk of potential interactions that could affect bleeding risk.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Tylenol Severe Cough Plus Sore Throat Day (acetaminophen and dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 6 hours as needed for symptom relief, with a maximum of 6 caplets in a 24-hour period. Treatment should not exceed 10 days unless directed by a healthcare provider.

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 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.

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 recommended dosage of 4,000 mg of acetaminophen in a 24-hour period, take other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with known liver disease consult a healthcare professional prior to use. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects associated with acetaminophen use.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and intervention may be necessary to address any complications that arise during the course of treatment.

It is vital to maintain open communication with poison control and other medical professionals to ensure the best possible outcomes for patients experiencing an overdose.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 informed 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 crucial to inform patients that this product should not be used 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 medication contains an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Healthcare providers should instruct patients to discontinue use and seek medical advice if pain or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. Additionally, patients should be advised to stop use and consult a doctor if new symptoms arise or if a cough returns, especially if accompanied by a rash or headache that lasts, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dose. Healthcare providers should also recommend that patients consult a doctor before use if they have liver disease, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or a cough that produces excessive phlegm. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in blister packaging. Each blister unit must be inspected prior to use; do not use if the blister unit is torn or broken.

For optimal storage, the product should be maintained at a temperature range of 20 to 25°C (68 to 77°F). Proper handling and storage conditions are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Extra Strength Tylenol Severe Cough Plus Sore Throat Day, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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