Extra Strength Tylenol Severe Cough Plus Sore Throat Night

Description

NDC 50580-243-01. Extra Strength Tylenol® is formulated for adults to address severe cough and sore throat symptoms. This product contains a combination of acetaminophen, dextromethorphan HBr, and doxylamine succinate, serving as a pain reliever and fever reducer, cough suppressant, and antihistamine. The dosage form is a liquid, presented in a frosted berry flavor, with a total volume of 8 fluid ounces (240 mL).

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, cough, sneezing, and runny nose. 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 over are instructed to take 30 mL of the medication using the dosing cup provided every 6 hours, as needed, while symptoms persist. It is imperative that the total daily dosage does not exceed 90 mL 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:

• Co-administration 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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek guidance from a healthcare professional.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe hypersensitivity reactions.

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 any of the following conditions: liver disease, respiratory issues such as emphysema or chronic bronchitis, glaucoma, difficulty urinating due to an enlarged prostate gland, persistent or chronic cough (e.g., associated with smoking, asthma, or emphysema), or a cough accompanied by excessive phlegm. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking blood thinners such as warfarin or sedatives/tranquilizers.

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

Discontinuation of Use Patients are advised to 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 beyond 3 days, presence of redness or swelling, emergence of new symptoms, or recurrence of cough accompanied by rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, 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.

During the use of this product, patients should adhere to the recommended dosage to mitigate risks. Excitability has been reported, particularly in children, and marked drowsiness may occur. The concomitant use of alcohol, sedatives, or tranquilizers can exacerbate drowsiness, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving or operating machinery due to the potential for drowsiness.

Patients are instructed to stop use 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, or if new symptoms arise. A cough that recurs or is accompanied by a rash or headache that lasts should also prompt medical consultation, as these may indicate a serious condition.

Additionally, patients should seek medical advice promptly if a sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting.

Drug Interactions

Concurrent use of this medication with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's disease, as well as for a period of 2 weeks following the discontinuation of an MAOI.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Additionally, caution is advised for individuals using sedatives or tranquilizers. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, necessitating careful monitoring of sedation levels and potential impairment in activities requiring alertness.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before use. In this population, excitability may occur, and marked drowsiness is also a potential side effect. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours as needed, not to exceed 90 mL in a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, use should not extend beyond 10 days unless advised by a doctor.

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 efficacy, 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.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. The presence of liver disease may increase the risk of adverse effects, particularly due to the acetaminophen content.

Severe liver damage may occur if patients exceed the recommended dosage of acetaminophen, which is limited to a maximum of 4,000 mg within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen, as this can further elevate the risk of liver toxicity.

Furthermore, consumption of three or more alcoholic beverages daily while using this product is contraindicated, as it may exacerbate the potential for liver damage. Monitoring of liver function is advised in patients with compromised liver function to ensure safety and efficacy during treatment.

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 intervention 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 appropriate interventions should be initiated as necessary to mitigate potential complications associated with the 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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize the necessity of adhering to the recommended dosage and to avoid exceeding it, as this can lead to adverse effects.

Patients should be informed that excitability may occur, particularly in children, and they should be made aware of the potential for marked drowsiness. It is crucial to discuss the interaction of this medication with alcohol, sedatives, and tranquilizers, as these substances may enhance drowsiness. Therefore, patients should be strongly advised to avoid alcoholic drinks while taking this medication.

Additionally, healthcare providers should caution patients about the risks associated with driving a motor vehicle or operating machinery, as drowsiness may impair their ability to perform these tasks safely.

Storage and Handling

The product is supplied in a configuration that includes specific packaging requirements. It must be stored at a temperature range of 20-25°C (68-77°F) to ensure optimal stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use. It should not be utilized if the neck band imprinted with "INSTANT COOLING SENSATION" or the foil inner seal imprinted with "TYLENOL" is broken or missing, as this may indicate potential tampering or compromise of the product's integrity.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older, not to exceed 90 mL in a 24-hour period unless directed by a physician. The use of this medication should not extend beyond 10 days unless advised by a healthcare provider.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222, as prompt attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

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