Cold and Flu

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including sore throat, nasal congestion, headache, minor aches and pains, and cough due to minor throat and bronchial irritation. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the prescribed dosage and administration guidelines.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours, not to exceed 4 doses within a 24-hour period. For children aged 6 to under 12 years, the appropriate dosage is 15 mL every 4 hours, also limited to a maximum of 4 doses in a 24-hour timeframe.

It is imperative that patients do not exceed the recommended dosage and utilize only the dose cup provided for accurate measurement. The product is not recommended for use in children under 6 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, is prohibited 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.

The product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric, or emotional conditions, as well as for Parkinson’s disease. Patients should verify with a healthcare provider if their current medications include an MAOI.

Additionally, this product is contraindicated in individuals with a history of allergic reactions to it or any of its components.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that adults must not exceed 4,000 mg of acetaminophen within a 24-hour period, and children should not take more than 5 doses in the same timeframe. Additionally, caution is warranted when this product is used in conjunction with other medications containing acetaminophen. Patients who consume three or more alcoholic drinks daily while using this product are at an increased risk for liver damage.

Acetaminophen may also provoke severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat, particularly if it persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician without delay.

It is imperative that patients do not exceed the recommended dosage of this product.

In the event of an overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center or seek emergency medical help, regardless of whether signs or symptoms are present.

Patients should also be advised to stop taking the product and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if fever worsens or persists beyond three days; if redness or swelling occurs; if new symptoms arise; or if pain, nasal congestion, or cough worsens or lasts beyond five days in children or seven days in adults. A return of cough accompanied by rash or headache that persists may indicate a serious condition requiring medical evaluation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen. Specifically, adults should not take more than 4,000 mg of acetaminophen within a 24-hour period, and children should not take more than 5 doses in the same timeframe. The risk of liver damage is further increased if the product is taken in conjunction with other medications containing acetaminophen or if the patient consumes three or more alcoholic drinks daily while using this product.

Patients should also be alert for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

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

Patients are advised to stop using the product and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, if fever worsens or lasts more than three days, or if redness or swelling is present, medical consultation is recommended. New symptoms that arise, or if pain, nasal congestion, or cough worsens or lasts beyond five days in children or seven days in adults, should also prompt a discussion with a healthcare provider. Cough that recurs or occurs alongside a rash or headache lasting for an extended period may indicate a serious condition and should be evaluated by a physician.

Drug Interactions

Acetaminophen has been observed to enhance the anticoagulant effect of warfarin, which may result in an elevated risk of bleeding complications. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients receiving both acetaminophen and warfarin to ensure safe therapeutic levels and to mitigate the risk of adverse effects.

No additional drug interactions or interactions with laboratory tests have been reported.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should not use this product. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. In contrast, adults and children aged 12 years and older may take 30 mL every 4 hours during the day and 30 mL every 6 hours at night.

Healthcare professionals should be aware of a liver warning indicating that if a child takes more than 5 doses within a 24-hour period, medical attention may be necessary. Additionally, excitability may occur, particularly in pediatric patients. Parents and caregivers are advised to stop use and consult a doctor if a child's pain, nasal congestion, or cough worsens or persists for more than 5 days.

Geriatric Use

Elderly patients may not require specific dosage adjustments or face unique safety concerns based on the available data. However, it is essential for healthcare providers to consider that certain medical conditions, which are more prevalent in geriatric patients, may necessitate consultation with a physician prior to use. These conditions include difficulty in urination due to prostate gland enlargement, heart disease, diabetes, thyroid disease, liver disease, and high blood pressure.

Caution is advised as marked drowsiness may occur with the use of this medication. Elderly patients may be particularly sensitive to these effects, and the concomitant use of alcohol, sedatives, or tranquilizers can exacerbate drowsiness.

Monitoring is crucial; if elderly patients experience symptoms such as nervousness, dizziness, or sleeplessness, it is recommended to discontinue use and consult a healthcare provider. This vigilance is particularly important in the geriatric population to ensure safety and efficacy.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if an adult exceeds a dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the risk of severe liver damage is heightened for individuals who consume three or more alcoholic drinks daily while using this product.

Before initiating treatment, patients with liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of treatment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. 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 early intervention can significantly impact the outcome of an overdose situation. Therefore, it is recommended to maintain a proactive approach in managing potential overdose cases.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability may occur, particularly in children, and marked drowsiness has been observed. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

No specific nonclinical toxicology information is available in the insert. Additionally, there is no specific animal pharmacology and toxicology information provided.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions, which can 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 reported, particularly in pediatric populations. Users may also experience marked drowsiness, which can be exacerbated by the consumption of alcohol, sedatives, or tranquilizers. Caution is recommended when driving or operating machinery due to the potential for increased 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 headache lasting longer than usual, as these may indicate a serious condition.

In cases of overdose, it is critical to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients on the importance of adhering to the recommended dosage of the medication. Patients must be informed that exceeding the recommended dosage can lead to serious health risks.

In the event of an overdose, it is crucial for patients to seek medical help immediately or contact a Poison Control Center. Healthcare providers should emphasize that prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly impact the outcome in cases of overdose.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permitted within the range of 15°C to 30°C (59°F to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians are advised to counsel patients regarding the importance of consulting a health professional if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended, as prompt attention is vital for both adults and children, even in the absence of symptoms.

Additionally, parents are encouraged to educate themselves about the potential for medicine abuse among teenagers by visiting www.StopMedicineAbuse.org. No further information is available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)