Tylenol Cold Plus Flu Plus Cough

Description

NDC 50580-369-01. TYLENOL® is formulated for adults to provide relief from cold, flu, and cough symptoms. Each 8 fl oz (240 mL) dose contains a combination of Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, and Phenylephrine HCl, serving as a pain reliever and fever reducer, cough suppressant, antihistamine, and nasal decongestant. The product is presented in a wild berry burst flavor and contains 0.7% alcohol.

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, nasal congestion, runny nose, sneezing, cough, and sinus congestion and pressure. It aids in clearing nasal passages and provides cough relief to facilitate sleep. 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 should 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 before 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.

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 includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should verify with a healthcare professional if their current medications include an MAOI.

• History of allergic reactions to this product or any of its ingredients, as this may lead to 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 beverages daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

Consultation Requirements Healthcare professionals should advise patients to consult a doctor promptly if they experience a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting.

General Precautions Patients should not use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are encouraged to consult a healthcare provider or pharmacist.

This product is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have ceased MAOI treatment within the past two weeks. Patients should verify with a healthcare provider or pharmacist if they are unsure whether their prescription includes an MAOI.

Individuals with a history of allergic reactions to this product or any of its components should avoid its use.

Patients should seek medical advice prior to 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, respiratory issues such as emphysema or chronic bronchitis, glaucoma, persistent or chronic cough (especially associated with smoking, asthma, or emphysema), or a cough accompanied by excessive phlegm.

Additionally, patients taking the anticoagulant warfarin or those on sedatives or tranquilizers should consult a healthcare professional or pharmacist before use.

Emergency Medical Help 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 and Medical Consultation Patients are advised to stop using this product and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever intensifies or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition requiring 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.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, or those who have stopped taking an MAOI within the past two weeks, should also avoid this product. Individuals with a known allergy to acetaminophen or any of its ingredients should refrain from use.

Patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, urinary difficulties due to an enlarged prostate gland, breathing problems such as emphysema or chronic bronchitis, glaucoma, or persistent coughs associated with smoking, asthma, or emphysema should consult a doctor before using this product. Additionally, those taking the blood-thinning medication warfarin or sedatives or tranquilizers should seek advice from a healthcare professional prior to use.

While using this product, patients must not exceed the recommended dose. Excitability may occur, particularly in children, and marked drowsiness is a potential side effect. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving or operating machinery.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs with a rash or headache that lasts. These symptoms may indicate a serious condition.

In the event of an overdose, it is critical 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.

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 Tylenol Cold Plus Flu Plus Cough (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, 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 before use. There is a potential for excitability, particularly in children, and marked drowsiness may also occur. For patients aged 12 years and older, the recommended dosage is 30 mL every 4 hours as needed, with a maximum of 150 mL in a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 detailed information on the use of this medication in the elderly population. Individualized assessment and clinical judgment are essential when determining the appropriateness of treatment in this demographic.

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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a healthcare 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 mothers.

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 individuals 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 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 within a 24-hour period. Additionally, the risk of liver damage increases if patients take this product concurrently with other medications that contain acetaminophen 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 using this product to assess the potential risks and determine appropriate usage. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

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

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may manifest as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately and medical assistance be sought.

Patient Counseling

Healthcare providers should advise patients to keep this product 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 medication contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important 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 includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. They should be instructed to stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be informed to discontinue use and consult a doctor if pain, nasal congestion, 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. New symptoms or a recurrence of cough, especially if accompanied by a rash or headache, should also prompt patients to seek medical attention, as these may indicate a serious condition.

Patients should be reminded to adhere to the recommended dosage and to be aware that excitability may occur, particularly in children. Marked drowsiness is a potential side effect, and patients should be cautioned that the use of alcohol, sedatives, or tranquilizers may enhance drowsiness. Therefore, patients should avoid alcoholic beverages while using this product and exercise caution when driving or operating machinery.

Before using this product, patients should be encouraged to consult a healthcare provider 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, breathing problems such as emphysema or chronic bronchitis, glaucoma, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Patients should also be advised to seek guidance if they have a cough that produces excessive phlegm. Furthermore, patients taking the blood-thinning medication warfarin or any sedatives or tranquilizers should consult a doctor or pharmacist prior to use.

Storage and Handling

The product is supplied in packaging that includes a neck band imprinted with "TYLENOL COLD+FLU+COUGH" 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 medication.

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 additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Tylenol Cold Plus Flu Plus Cough, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)