Tylenol Cold Plus Mucus Severe

Description

TYLENOL® COLD + MUCUS SEVERE is a combination medication formulated to provide relief from multiple cold symptoms. Each 8 fl oz (240 mL) dosage contains Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, and Guaifenesin, serving as a pain reliever and fever reducer, cough suppressant, nasal decongestant, and expectorant. The product contains 0.7% alcohol. The National Drug Code (NDC) for this formulation is 50580-511-01.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza, including minor aches and pains, headache, sore throat, nasal congestion, and cough. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby enhancing the productivity of coughs. Additionally, this drug temporarily reduces 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 4 hours as needed while symptoms persist. The total daily dosage must not exceed 150 mL within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is recommended to consult a doctor prior to administration.

It is essential to utilize only the enclosed dosing cup specifically designed for this product. The use of any other dosing device is not advised. Patients should adhere strictly to the recommended dosage to avoid the risk of overdose.

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.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI. This is particularly relevant for medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease, as the combination may lead to serious adverse effects. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted.

• History of allergic reaction 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 any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should be cautioned to seek advice from a doctor or pharmacist if they are currently taking the anticoagulant warfarin.

Dosage Recommendations 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 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 should stop taking this product and consult a doctor if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than seven days; fever that worsens or persists beyond three 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

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 that acetaminophen may cause 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 and seek medical assistance immediately.

In cases of severe sore throat that 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 stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts more 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, as these may indicate a serious condition.

Prior to use, patients should seek medical advice if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, 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 also consult a healthcare provider.

Patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

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 increased bleeding.

Packaging & NDC

Below are the non-prescription pack sizes of Tylenol Cold Plus Mucus Severe (acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important for caregivers to seek medical advice to ensure the safety and appropriateness of treatment for this age group.

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. 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 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 patients 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 consult a healthcare professional prior to using this product. The presence of liver disease may necessitate careful consideration of the risks associated with acetaminophen use.

Acetaminophen is known to pose a risk of severe liver damage, particularly when the total daily dosage exceeds 4,000 mg within a 24-hour period. Additionally, the risk of liver injury is heightened when acetaminophen is taken in conjunction with other medications containing acetaminophen or when the patient consumes three or more alcoholic beverages daily while using this product.

Due to these factors, it is essential for patients with compromised liver function to adhere strictly to recommended dosages and to engage in regular monitoring of liver function as advised by their healthcare provider.

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 presentation of symptoms may vary, and vigilance is necessary to ensure appropriate management. The potential for serious complications underscores the importance of rapid response in overdose situations.

Management procedures should include a thorough assessment of the patient's condition, monitoring vital signs, and providing supportive care as needed. It is essential to follow established protocols for overdose management, which may involve decontamination, administration of antidotes if applicable, and symptomatic treatment.

In summary, the critical nature of overdose situations necessitates immediate action and adherence to medical guidelines to ensure patient safety and effective management.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. There are no specific non-teratogenic effects or nonclinical toxicology details available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may include symptoms such as skin reddening, blisters, and rash. In cases where a skin reaction occurs, users are advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Patients should be advised to keep this product out of reach of children to prevent accidental ingestion. It is important to inform patients not to use this product in conjunction with any other medication 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.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If patients are unsure whether their prescription includes an MAOI, they should seek guidance from a healthcare professional.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised not to use it. They should also be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Instruct patients to stop using the product and seek medical advice if their pain, nasal congestion, or cough worsens or persists for more than seven days. Additionally, they should be informed to contact a healthcare provider if their fever worsens or lasts longer than three days, or if they notice any redness or swelling. New symptoms that arise should also prompt a consultation with a doctor.

Patients should be made aware that if their cough returns or occurs alongside a rash or persistent headache, they should seek medical attention, as these could indicate a serious condition. It is crucial to emphasize that patients must not exceed the recommended dose while using this product.

Before using this product, patients should be encouraged to consult a doctor if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. 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 use. Those experiencing a cough accompanied by excessive phlegm (mucus) should also consult a healthcare professional.

Lastly, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in packaging that includes a neck band imprinted with "TYLENOL COLD + MUCUS SEVERE" and a foil inner seal marked with "SAFETY SEAL®." It is essential to ensure that these seals are intact before use, as the product should not be utilized if either the neck band or the foil seal is broken or missing.

For optimal storage, the product must be kept at a temperature range of 20-25°C (68-77°F). It is important to note that refrigeration is not permitted, as exposure to lower temperatures may compromise the integrity of the product. Proper handling and storage conditions are crucial to maintain the efficacy and safety of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare 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 Tylenol Cold Plus Mucus Severe, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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