Tylenol Cold Plus Flu Multi-Symptom Gels Night

Description

TYLENOL® is a cold and flu multi-symptom formulation indicated for adults. Each dosage form consists of liquid-filled capsules containing active ingredients: acetaminophen, dextromethorphan HBr, and doxylamine succinate. This product serves multiple therapeutic purposes, including pain relief, fever reduction, cough suppression, and antihistamine effects. It is designed to alleviate symptoms such as head and body aches, fever, sore throat, cough, and runny nose. The product is available in a quantity of 24 liquid gels. The National Drug Code (NDC) for this formulation is 50580-131-24.

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, runny nose, and sneezing. Additionally, it temporarily reduces fever associated with these conditions.

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 6 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 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 advice from a healthcare professional.

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

• Exceeding the recommended dose is contraindicated to prevent potential toxicity.

• Consumption of alcoholic beverages is advised against, as it may exacerbate the risk of adverse effects.

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.

Severe Sore Throat In instances where a sore throat is severe, persists beyond two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is essential to consult a healthcare professional promptly.

General Precautions This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a doctor or pharmacist is advised. Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. If there is uncertainty about whether a prescription drug contains an MAOI, it is crucial to seek guidance from a healthcare professional. Furthermore, individuals with a history of allergic reactions to this product or any of its components should refrain from use.

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

When to Stop Taking the Product Discontinuation of this product and consultation with a healthcare provider is warranted if any of the following occur: pain or cough worsens or persists beyond seven days; fever worsens or lasts more than three days; redness or swelling is observed; new symptoms arise; or if a cough recurs alongside a rash or headache that persists. These symptoms may indicate a serious underlying condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Patients should be aware that acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription, without consulting a healthcare provider. Additionally, it is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Individuals with a known allergy to this product or any of its ingredients should also refrain from use.

Patients with liver disease, glaucoma, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, or persistent coughs associated with smoking, asthma, or emphysema should seek medical advice before using this product. Furthermore, those taking blood thinners such as warfarin or sedatives and tranquilizers should consult a healthcare professional prior to use.

While using this product, patients should adhere to the recommended dosage to avoid adverse effects. Notably, excitability may occur, particularly in children, and marked drowsiness may be experienced. The use of alcohol, sedatives, and tranquilizers can exacerbate drowsiness, and patients are advised to avoid alcoholic beverages and exercise caution when driving or operating machinery.

Patients 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, or if new symptoms develop. 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.

In the event of an overdose, immediate medical attention is critical for both adults and children, even if no signs or symptoms are apparent. Patients are encouraged to contact a Poison Control Center or seek medical help without delay.

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 and potential hepatotoxicity.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, as well as for a period of 2 weeks following the discontinuation of an MAOI. This combination may lead to serious and potentially life-threatening interactions.

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

Caution is advised when this medication is used in conjunction with alcohol, sedatives, or tranquilizers, as these substances may enhance drowsiness and impair cognitive and motor functions. Monitoring for increased sedation and potential respiratory depression is recommended in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Tylenol Cold Plus Flu Multi-Symptom Gels Night (acetaminophen, dextromethorphan hydrobromide and doxylamine succinate). 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 adults and children aged 12 years and older, the recommended dosage is 2 capsules every 6 hours as needed, with a maximum of 8 capsules in a 24-hour period.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 should consider individual circumstances and the specific health needs of the patient when making recommendations.

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 considering the use of this medication during lactation.

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 prudent 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, take this product in conjunction with other medications containing 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 prevent 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 amount ingested and the individual’s health status. Therefore, it is essential to monitor the patient closely and provide supportive care as needed.

Management of an overdose may involve symptomatic treatment and monitoring of vital signs. The healthcare provider should be prepared to implement appropriate interventions based on the clinical presentation of the patient.

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 several adverse events reported voluntarily or through surveillance programs. Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been noted, particularly in pediatric populations, alongside marked drowsiness. The concurrent use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Healthcare professionals should be consulted 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 a headache that persists. These symptoms may indicate a serious underlying condition.

In cases of overdose, it is imperative to seek medical help or contact a Poison Control Center without delay, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

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 that patients should not exceed the recommended dose, as doing so may lead to adverse effects.

Patients should be informed that excitability may occur, particularly in children, and that marked drowsiness is a possible side effect. They should be cautioned about the potential for increased drowsiness when consuming alcohol, sedatives, or tranquilizers, and it is advisable to avoid alcoholic drinks while using this medication.

Providers should remind patients to exercise caution when driving a motor vehicle or operating machinery due to the risk of drowsiness.

Patients should be encouraged to consult with their healthcare provider before use if they have any of the following conditions: liver disease, glaucoma, breathing problems such as emphysema or chronic bronchitis, difficulty urinating due to an enlarged prostate gland, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or a cough that produces excessive phlegm.

Additionally, patients should be advised to seek guidance from a doctor or pharmacist before using this medication if they are currently taking the blood-thinning drug warfarin or any sedatives or tranquilizers.

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). Care must 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 maintain its integrity. Healthcare professionals are advised not to use the product if the blister unit is found to be torn or broken.

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 Flu Multi-Symptom Gels Night, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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