Cold Flu

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

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

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a physician for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

Healthcare professionals should monitor patients for adherence to these guidelines to prevent 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 includes certain 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

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period; if a child takes more than 5 doses in 24 hours; if it is taken concurrently with other medications containing acetaminophen; or if an adult consumes 3 or more alcoholic beverages daily while using this product.

Acetaminophen may also 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 immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be advised to seek medical advice if they have liver disease, a cough that produces excessive phlegm, or a persistent or chronic cough associated with smoking, asthma, or emphysema. Additionally, it is recommended that patients consult a doctor or pharmacist before using this product if they are currently taking the anticoagulant warfarin.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, even if no signs or symptoms are apparent.

Patients should discontinue use and contact a healthcare provider if any of the following occur: pain or cough worsens or lasts longer than 5 days in children or 7 days in adults; fever worsens or lasts more than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg within a 24-hour period, a child takes more than five doses in the same timeframe, or if the medication is taken concurrently with other products containing acetaminophen. Additionally, adults who consume three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

A sore throat warning is also in place; if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, patients should consult a healthcare provider promptly.

Patients are advised to stop use and consult a doctor if pain or cough worsens or lasts longer than five days in children or seven days in adults, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms occur, or if a cough returns or occurs with a rash or headache that persists, as these may indicate a serious condition.

Before using this product, patients with liver disease, those experiencing a cough with excessive phlegm, or individuals with a persistent or chronic cough (such as those associated with smoking, asthma, or emphysema) should seek medical advice. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

In cases of overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Quick medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Patients taking the blood-thinning medication warfarin should consult a healthcare professional prior to using acetaminophen. This combination may influence International Normalized Ratio (INR) levels, necessitating careful monitoring to ensure safe and effective anticoagulation therapy.

No additional drug interactions or laboratory test interactions have been identified for this medication.

Packaging & NDC

Below are the non-prescription pack sizes of Cold Flu (acetaminophen, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a doctor before use. The product is not recommended for children under 4 years of age.

Healthcare professionals should be aware that administering more than 5 doses within a 24-hour period may result in severe liver damage. Additionally, if a child's pain or cough worsens or persists for more than 5 days, it is important to discontinue use and seek medical advice.

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 safe use during pregnancy and lactation.

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 drug 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 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, as it contains acetaminophen, which is associated with the risk of severe liver damage. The following considerations are essential for this patient population:

Severe liver damage may occur if an adult exceeds 4,000 mg of acetaminophen within a 24-hour period. For children, the risk increases if more than 5 doses are taken in the same timeframe. Additionally, the concurrent use of other medications containing acetaminophen can further elevate the risk of liver injury. Patients who consume 3 or more alcoholic drinks daily while using this product are also at heightened risk for liver damage.

It is imperative that patients with a history of liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in patients with compromised liver function 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, and early recognition and management are essential to mitigate potential complications. It is recommended that all cases of suspected overdose be treated as medical emergencies, and appropriate supportive care should be initiated as necessary.

Monitoring and supportive measures may be required based on the clinical presentation of the patient. Continuous assessment of vital signs and symptomatic treatment should be provided as needed.

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 the following adverse reactions: severe skin reactions, which may present as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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