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Cold and Flu

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Active ingredients
  • Acetaminophen 325 mg/15 mL
  • Dextromethorphan Hydrobromide 10 mg/15 mL
  • Phenylephrine Hydrochloride 5 mg/15 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
September 25, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg/15 mL
  • Dextromethorphan Hydrobromide 10 mg/15 mL
  • Phenylephrine Hydrochloride 5 mg/15 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
September 25, 2024
Manufacturer
Walgreen Company
Registration number
M017
NDC root
0363-0666
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Walgreens Cold & Flu is a daytime, non-drowsy medication designed to help relieve multiple symptoms associated with the common cold and flu. It contains a combination of acetaminophen (a pain reliever and fever reducer), dextromethorphan HBr (a cough suppressant), and phenylephrine HCl (a nasal decongestant). This product is formulated to temporarily alleviate symptoms such as nasal congestion, cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

This medication is alcohol-free and does not contain antihistamines, making it suitable for daytime use. It is recommended by Walgreens pharmacists and can be compared to similar products like Vicks DayQuil for its effectiveness in managing cold and flu symptoms.

Uses

If you're dealing with the discomfort of a common cold or flu, this medication can help temporarily relieve several bothersome symptoms. You can expect relief from nasal congestion, a cough caused by minor throat and bronchial irritation, and a sore throat. Additionally, it can help ease headaches, minor aches and pains, and fever.

This medication is designed to make you feel more comfortable while your body fights off the illness, allowing you to rest and recover more effectively.

Dosage and Administration

It's important to take this medication exactly as directed to ensure your safety. You should only use the dose cup that comes with the medication to measure your doses. Remember, you should not exceed 4 doses in a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 30 mL every 4 hours. If your child is between 6 and under 12 years old, they should take 15 mL every 4 hours. For children aged 4 to under 6 years, it's best to consult a doctor before giving them this medication. Lastly, do not use this medication for children under 4 years old. Always follow these guidelines to ensure safe and effective use.

What to Avoid

You should avoid using this product if you are currently taking any other medication that contains acetaminophen, whether it's a prescription or over-the-counter drug. If you're unsure about a medication, it's best to consult with your doctor or pharmacist. Additionally, do not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson’s disease, or for two weeks after stopping an MAOI. If you have a history of allergic reactions to this product or any of its ingredients, you should also refrain from using it.

It's important to follow the dosage instructions carefully and not exceed the recommended amount. Always prioritize your safety by discussing any concerns or questions with a healthcare professional.

Side Effects

You should be aware that taking too much acetaminophen can lead to severe liver damage. For adults, this can happen if you exceed 4,000 mg in a 24-hour period, while children are at risk if they take more than five doses in the same timeframe. Additionally, combining acetaminophen with other medications that contain it or consuming three or more alcoholic drinks daily while using this product can increase the risk of liver damage.

There are also important allergy alerts; acetaminophen may cause serious skin reactions, including redness, blisters, or rashes. If you experience any of these symptoms, stop using the product and seek medical help immediately. If you have a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, consult a doctor. Be sure to stop use and contact a healthcare professional if you feel nervous, dizzy, or sleepless, or if your symptoms worsen or persist beyond the recommended duration.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you exceed 4,000 mg in 24 hours (for adults) or if a child takes more than 5 doses in the same timeframe. Be cautious if you consume three or more alcoholic drinks daily while using this product, or if you are taking other medications that also contain acetaminophen. Additionally, be aware that acetaminophen may cause serious skin reactions, such as redness, blisters, or rashes. If you experience any of these symptoms, stop using the product and seek medical help immediately.

Before using this product, consult your doctor if you have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate. If you are taking the blood thinner warfarin, check with your doctor or pharmacist before use. If you experience symptoms like dizziness, worsening pain, or a persistent cough, or if new symptoms develop, stop taking the product and contact your doctor.

In case of an overdose, seek emergency medical help or contact a Poison Control Center at 1-800-222-1222 right away, even if you do not notice any symptoms. Quick action is crucial for both adults and children.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick action is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Remember, an overdose can happen without obvious warning signs, so don’t wait to get help. Always prioritize safety and reach out for assistance right away.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When giving medication to children, it's important to follow specific guidelines based on their age. For children aged 6 to under 12 years, the recommended dosage is 15 mL every 4 hours. If your child is between 4 and under 6 years old, you should consult a doctor before administering the medication. For children under 4 years, this medication should not be used at all.

Additionally, be aware of the overdose warning: if you suspect your child has taken too much, seek medical help immediately, even if they don't show any signs or symptoms. Your child's safety is the top priority, so always follow these guidelines closely.

Geriatric Use

When it comes to using this medication in older adults, there are no specific guidelines or recommendations regarding age-related dosage adjustments or safety concerns. This means that while the medication can be prescribed to older patients, healthcare providers may not have tailored advice for managing its use in this age group.

As always, it’s important for you or your caregiver to discuss any concerns with your healthcare provider, especially if you have other health conditions or are taking multiple medications. Your provider can help ensure that the treatment is safe and effective for your individual needs.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication, especially if you experience difficulty urinating due to an enlarged prostate gland. Your healthcare provider can help determine if this medication is safe for you and may suggest adjustments to your dosage or monitoring based on your kidney function. Always prioritize open communication with your doctor regarding any concerns related to your kidney health.

Hepatic Impairment

If you have liver disease, it’s important to consult your doctor before using this product. This medication contains acetaminophen, which can be harmful to your liver. Taking more than 4,000 mg of acetaminophen in a 24-hour period can lead to severe liver damage. Additionally, if you consume three or more alcoholic drinks each day while using this product, you also risk serious liver damage.

To ensure your safety, always discuss your liver health with your healthcare provider and follow their recommendations regarding dosage and alcohol consumption while using medications that contain acetaminophen.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are taking the blood thinner warfarin. Mixing these can increase your risk of bleeding, so it's crucial to get professional advice.

Additionally, you should avoid using this medication with any other products that contain acetaminophen, which is a common pain reliever found in many over-the-counter and prescription drugs. If you're unsure whether a medication contains acetaminophen, don't hesitate to ask a healthcare professional. Lastly, if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson’s disease, or if you have stopped taking one in the last two weeks, you should not use this medication. Always consult with your healthcare provider to ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Additionally, make sure to keep this medication out of reach of children to ensure their safety.

FAQ

What is Acetaminophen / Dextromethorphan HBr / Phenylephrine HCl used for?

It is used to temporarily relieve common cold and flu symptoms, including nasal congestion, cough, sore throat, headache, minor aches and pains, and fever.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 30 mL every 4 hours.

Can children under 4 years use this medication?

No, it should not be used in children under 4 years.

What should I do if I experience severe skin reactions?

If you notice symptoms like skin reddening, blisters, or rash, stop use and seek medical help immediately.

What are the liver warnings associated with this product?

Severe liver damage may occur if an adult takes more than 4,000 mg of acetaminophen in 24 hours or if they consume 3 or more alcoholic drinks daily while using this product.

Are there any contraindications for using this medication?

Yes, do not use it with any other drug containing acetaminophen or if you are taking a prescription monoamine oxidase inhibitor (MAOI).

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Is this medication safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What should I do if my symptoms worsen or new symptoms occur?

Stop taking the medication and consult a doctor if your pain, nasal congestion, or cough worsens or lasts longer than the recommended duration.

Packaging Info

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

Packaging configurations for Cold and Flu.
Details

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)

Description

Walgreens Cold & Flu is a multi-symptom formulation designed for daytime use, providing non-drowsy relief from common cold and flu symptoms. Each 12 FL OZ (355 mL) bottle contains a combination of active ingredients: acetaminophen for pain relief and fever reduction, dextromethorphan HBr as a cough suppressant, and phenylephrine HCl to alleviate nasal congestion. This product is free from antihistamines and alcohol, making it suitable for individuals seeking symptom relief without sedation. The formulation is comparable to the active ingredients found in Vicks® DayQuil®.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, 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. The medication is not recommended for 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:

Patients should not use this product in conjunction 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.

The product is contraindicated in individuals 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. Patients should verify with a healthcare professional if their prescription includes an MAOI.

Additionally, this product should not be used by individuals with a known 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 if this product is taken concurrently with other medications containing acetaminophen or if the adult consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also provoke severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients must be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

General precautions should be taken for patients with specific health conditions. Prior to use, individuals should consult a healthcare professional if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Patients with persistent or chronic coughs, such as those related to smoking, asthma, or emphysema, should also seek medical advice before use. Furthermore, it is essential to consult a doctor or pharmacist if the patient is currently taking the anticoagulant warfarin.

In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults, or if fever worsens or lasts more than 3 days, medical consultation is necessary. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache should also prompt immediate medical evaluation, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, or in children who take more than 5 doses in the same timeframe. The risk of liver damage is heightened when acetaminophen is taken in conjunction with other medications containing acetaminophen or when an adult consumes 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.

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.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than 5 days in children or 7 days in adults; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

Prior to using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing trouble urinating due to an enlarged prostate gland should seek medical advice. Additionally, patients with a cough that produces excessive phlegm or those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should consult a healthcare provider.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before use.

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

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking warfarin, a blood-thinning medication, due to the potential for increased bleeding risk.

Co-administration with any other product containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients are advised to verify the presence of acetaminophen in other medications with a healthcare provider or pharmacist if uncertain.

The use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric conditions, or Parkinson’s disease. Patients should seek clarification from a healthcare professional if they are unsure whether their prescription includes an MAOI.

Packaging & NDC

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

Packaging configurations for Cold and Flu.
Details

Pediatric Use

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

Healthcare professionals should be aware of the critical nature of overdose situations in pediatric patients. Quick medical attention is essential, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific recommendations regarding age considerations, 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 potential for altered pharmacokinetics and pharmacodynamics 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 assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding 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 should consult a healthcare professional prior to use, particularly if they experience difficulties urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product. The presence of liver disease may necessitate caution due to the potential for adverse effects.

This product contains acetaminophen, which is associated with a risk of severe liver damage. Adults should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period, as exceeding this limit may lead to significant hepatic injury.

Additionally, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage. It is advisable for patients with compromised liver function to adhere strictly to recommended dosages and to discuss their alcohol consumption with their healthcare provider to mitigate potential risks. Regular monitoring of liver function may be warranted in these patients 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 based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be instructed not to exceed the recommended dosage. They should also be informed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults, patients should stop use and seek medical advice.

Healthcare providers should counsel patients to stop using the medication and consult a doctor if fever worsens or lasts more than 3 days, if there is any redness or swelling, or if new symptoms develop. Patients should also be made aware that if a cough returns or occurs alongside a rash or persistent headache, they should seek medical attention, as these may indicate a serious condition.

It is important for healthcare providers to remind patients to consult a doctor before using the medication if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek medical advice if they have a cough accompanied by excessive phlegm or a persistent or chronic cough related to smoking, asthma, or emphysema.

Lastly, patients taking the blood-thinning medication warfarin should be encouraged to consult a doctor or pharmacist before using this product.

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 exposure to extreme temperatures, which may compromise the product's quality.

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. Additionally, it is important to keep the medication out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, 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)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Cold and Flu, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.