Tylenol Cold Plus Flu

Description

NDC 50580-402-26. TYLENOL® is indicated for adults for the relief of symptoms associated with severe cold and flu. Each caplet contains a combination of active ingredients: Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, and Guaifenesin. This formulation serves multiple purposes, acting as a pain reliever and fever reducer, cough suppressant, nasal decongestant, and expectorant. The product is available in a package containing 24 caplets, each of actual size.

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. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby enhancing the productivity of coughs. The drug also temporarily reduces fever.

There are no teratogenic or nonteratogenic effects associated with this medication.

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 caplets every 4 hours as needed. The caplets should be swallowed whole and must not be crushed, chewed, or dissolved to ensure proper release and absorption of the medication. It is important to note that the maximum dosage should not exceed 10 caplets within a 24-hour period.

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 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. 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 components, as this may lead to severe adverse reactions.

Warnings and Precautions

This product contains acetaminophen, and it is critical to adhere to the maximum daily dosage of 10 caplets (3,250 mg acetaminophen) within a 24-hour period. Severe liver damage may occur if the following conditions are met: exceeding 4,000 mg of acetaminophen in 24 hours, concomitant use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may induce severe skin reactions. Symptoms indicative of such reactions may include skin reddening, blisters, and rash. In the event of a skin reaction, 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 persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking the anticoagulant warfarin.

Dosage Compliance Patients must not exceed the recommended dosage while using this product to mitigate the risk of adverse effects.

Monitoring for Adverse Reactions Patients should be instructed to discontinue use and consult a healthcare provider if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, 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 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 should verify the presence of acetaminophen in other medications with a doctor or pharmacist if uncertain. Additionally, this product is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Those with a known allergy to this product or any of its ingredients should also refrain from use.

Patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland should consult a doctor before using this product. Furthermore, individuals with persistent or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to use. Patients taking the blood-thinning medication warfarin should also consult a healthcare professional before using this product.

Patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists for more than 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 or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition requiring medical evaluation.

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, which can lead to severe liver damage.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be administered within 2 weeks of discontinuing an MAOI, as this may lead to serious adverse effects.

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 avoid potential interactions that could affect bleeding risk.

Packaging & NDC

Below are the non-prescription pack sizes of Tylenol Cold Plus Flu (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 before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 10 caplets in a 24-hour period.

In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent. It is important to keep this medication out of reach of children to prevent accidental ingestion.

Geriatric Use

There is no specific information available 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, 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 currently no available data on 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. The maximum daily dose is limited to 10 caplets, equating to 3,250 mg of acetaminophen within a 24-hour period. It is critical to note that severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients with known liver disease are advised to consult a healthcare professional prior to use. Monitoring of liver function may be warranted in these individuals to prevent potential adverse effects associated with acetaminophen.

Overdosage

In the event of an overdosage, it is critical to recognize the potential risks associated with the active ingredient, acetaminophen. The maximum recommended daily dose of this product is 10 caplets, equating to 3,250 mg of acetaminophen within a 24-hour period. Exceeding this dosage can lead to severe liver damage.

Risk Factors for Severe Liver Damage

Healthcare professionals should be aware that the risk of liver damage increases significantly under the following circumstances:

• Administration of more than 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use of other medications that also contain acetaminophen.

• Consumption of three or more alcoholic beverages daily while using this product.

Recommended Actions in Case of Overdosage

In the event of suspected overdosage, immediate medical attention is essential. Healthcare providers should assess the patient's condition and consider the following management procedures:

1. Assessment: Evaluate the patient's symptoms and medical history, including any concurrent medications and alcohol consumption.

2. Supportive Care: Initiate supportive care as necessary, monitoring liver function and vital signs.

3. Antidote Administration: N-acetylcysteine (NAC) is the recommended antidote for acetaminophen overdose and should be administered as soon as possible, ideally within 8 hours of ingestion.

Prompt recognition and management of acetaminophen overdosage are crucial to mitigate the risk of severe liver injury and improve patient outcomes.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions associated with acetaminophen use: severe skin reactions, which include skin reddening, blisters, and rash. These events have been reported voluntarily or through surveillance programs.

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 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.

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 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. They should be instructed to stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised 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 that lasts, should also prompt patients to seek medical attention, as these may indicate a serious condition.

Patients must be reminded not to exceed the recommended dose while using this product. It is essential for patients to consult a doctor before use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or if they have 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 with excessive phlegm (mucus) should also consult a healthcare provider. Lastly, patients taking the blood-thinning medication warfarin should be advised to speak with their doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in blister packaging. Each blister unit must be inspected prior to use; do not use if the blister unit is torn or broken.

For optimal storage, the product should be maintained at a temperature range of 20-25°C (68-77°F). Proper handling and storage conditions are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 caplets orally every 4 hours, ensuring they swallow the caplets whole without crushing, chewing, or dissolving them. It is important not to exceed 10 caplets within a 24-hour period.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. Additionally, patients should be reminded 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 crucial for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

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

View product document (PDF)