Cold and Flu

Description

This formulation contains three active ingredients: acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; and diphenhydramine succinate, an antihistamine. It is indicated for use in individuals aged 12 years and over. The product is presented in a cherry flavor and is packaged in a 12 FL OZ (355 mL) container.

The product features a tamper-evident statement, indicating that it should not be used if the printed neck wrap is broken or missing. It is distributed by Walgreen Co., located in Deerfield, IL 60015. The National Drug Code (NDC) for this product is 0363-9913-02. Copyright for this formulation is held by Walgreen Co., ©2024.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including headache, minor aches and pains, sore throat, runny nose, sneezing, 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 are advised to instruct patients to adhere strictly to the recommended dosage guidelines. The maximum dosage should not exceed four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 30 mL administered every 6 hours as needed. It is imperative that patients utilize only the dose cup provided with the medication to ensure accurate dosing.

The medication is not indicated for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use 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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) 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. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

• In individuals with a known history of allergic reactions to this product or any of its ingredients, to prevent potential 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.

Acetaminophen may also trigger 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 sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be instructed to seek medical advice if they have difficulty urinating due to prostate gland enlargement, a cough associated with excessive phlegm, a chronic cough or breathing problems related to smoking, asthma, chronic bronchitis, emphysema, liver disease, or glaucoma. Additionally, patients should consult a doctor or pharmacist if they are taking the anticoagulant warfarin or any sedatives or tranquilizers.

In the event of an overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should discontinue use and contact a healthcare provider if any of the following occur: worsening pain or cough lasting more than seven days, fever worsening or lasting more than three 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 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. Additionally, 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 doctor promptly.

While using this product, excitability may occur, particularly in children. Patients are advised to avoid alcoholic beverages, as alcohol, sedatives, and tranquilizers may enhance drowsiness, which can be marked. Caution is recommended when driving a motor vehicle or operating machinery due to the potential for drowsiness.

Patients should discontinue use and consult a doctor if pain or cough worsens or lasts more than seven days, if fever worsens or lasts more than three days, if redness or swelling is present, if new symptoms occur, or if a cough recurs with a rash or headache that persists, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have difficulty urinating due to prostate gland enlargement, a cough accompanied by excessive phlegm, a chronic cough or breathing problem related to smoking, asthma, chronic bronchitis, or emphysema, liver disease, or glaucoma. Furthermore, patients should seek advice from a doctor or pharmacist if they are taking the blood-thinning medication warfarin or are using sedatives or tranquilizers.

In the event of an overdose, it is crucial 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 for depression, psychiatric conditions, or Parkinson’s disease. It is advised to avoid this medication for at least two weeks following the discontinuation of an MAOI to prevent serious interactions.

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

Additionally, caution is advised for individuals using sedatives or tranquilizers. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, which could impair the ability to perform tasks requiring alertness. Monitoring for increased sedation is recommended in these cases.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage is 30 mL every 6 hours.

Healthcare professionals should be aware that excitability may occur, particularly in children. It is essential to seek prompt medical attention for both adults and pediatric patients, even in the absence of noticeable signs or symptoms.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients 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. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use with other medications containing acetaminophen is contraindicated, as this may lead to unintentional overdose and increased risk of liver damage.

• Consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate the risk of liver injury.

Additionally, patients with a history of liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

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 intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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

Patients should be advised to seek immediate medical help or contact a Poison Control Center in the event of an overdose, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are present.

It is important to inform patients that they should not 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 consult a doctor or pharmacist.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson’s disease, or if they have stopped taking an MAOI within the past two weeks. If patients are unsure whether their prescription includes an MAOI, they should seek guidance from a healthcare professional.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised not to use it. They should also be instructed to discontinue use and consult a doctor if pain or cough worsens or persists for more than 7 days, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms develop. Additionally, patients should be informed to stop use and seek medical advice if a cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients may experience excitability, particularly in children. They should be advised to avoid alcoholic beverages, as alcohol can exacerbate drowsiness, which may also be heightened by the use of sedatives and tranquilizers. Patients should exercise caution when driving or operating machinery due to the potential for marked drowsiness.

Patients should be encouraged to consult a doctor before using this product if they have difficulty urinating due to an enlarged prostate gland, a cough associated with excessive phlegm, a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, liver disease, or glaucoma. Furthermore, patients taking the blood-thinning medication warfarin or any sedatives or tranquilizers should also seek advice from a healthcare professional prior to use.

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 permissible within the range of 15° to 30°C (59° 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, with a recommended dosage of 30 mL every 6 hours for adults and children aged 12 years and older. Clinicians are advised to counsel patients regarding the importance of consulting a health professional if they are pregnant or breastfeeding before using the medication.

Additionally, resources are available for understanding the risks of medicine abuse among teens, specifically at 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)