Tylenol Cold Plus Flu Multi-Symptom Liquid Gels Day

Description

NDC 50580-130-24, TYLENOL® is formulated for adults as a multi-symptom liquid gel intended for the relief of cold and flu symptoms. Each liquid-filled capsule contains acetaminophen, a pain reliever and fever reducer, and dextromethorphan HBr, a cough suppressant. The product is presented in a package containing 24 liquid gels, designed for ease of administration.

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, and 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 capsules every 4 hours as needed for symptom relief. The maximum allowable dosage is 8 capsules within a 24-hour period.

For children aged 4 to under 12 years, it is recommended to consult a physician for appropriate dosing guidance.

The use of this medication is not advised for children under 4 years of age.

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 a history of liver disease, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or a cough accompanied by excessive phlegm (mucus). Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist prior to use.

Emergency Medical Assistance In the event of an overdose, it is crucial to obtain medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation and Medical Consultation 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 beyond a reasonable duration. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use it in conjunction with other drugs 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.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients are advised to consult a healthcare professional if they are uncertain whether a drug contains acetaminophen. Additionally, this product is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the cessation of an MAOI. Those with a history of allergic reactions to this product or any of its ingredients should also refrain from use.

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 doctor prior to using this product.

While using this product, patients must adhere to the recommended dosage and should discontinue use and consult a healthcare provider if pain 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 arise, or if a cough recurs with a rash or headache lasting longer than expected. These symptoms may indicate a serious condition.

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 Tylenol Cold Plus Flu Multi-Symptom Liquid Gels Day (acetaminophen, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 4 to under 12 years should consult a healthcare professional before use. The product is contraindicated in children under 4 years of age. For patients aged 12 years and older, the recommended dosage is 2 capsules every 4 hours as needed, with a maximum of 8 capsules in a 24-hour period.

Healthcare providers should be aware of the importance of quick medical attention in cases of overdose, as it is critical for both adults and pediatric patients, even in the absence of noticeable signs or symptoms.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 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 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 drinks 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 health 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 attention 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 timely intervention.

Management procedures should include a thorough assessment of the patient's condition, monitoring for any emerging symptoms, and implementing supportive care as needed. It is essential to follow established protocols for overdose management to mitigate risks and ensure patient safety.

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 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 this product 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 their pain or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if they notice any redness or swelling. Additionally, patients should be advised to stop using the product 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 associated with smoking, asthma, or emphysema, or if they have a cough that produces excessive phlegm. Lastly, 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 a blister pack configuration. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Care should be taken to avoid exposure to high humidity and excessive heat, specifically temperatures exceeding 40°C (104°F). Additionally, the product must be protected from light to ensure its stability. Healthcare professionals are advised not to use the product if the blister unit is found to be torn or broken, as this may compromise its integrity.

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 Tylenol Cold Plus Flu Multi-Symptom Liquid Gels Day, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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