Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Cold and Flu

Last content change checked dailysee data sync status

Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Tablet, Film Coated
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
January 27, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Tablet, Film Coated
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
January 27, 2026
Manufacturer
Walgreen Company
Registration number
M012
NDC root
0363-0640
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Walgreens Day Severe Cold & Flu is a maximum strength medication designed to temporarily relieve symptoms associated with the common cold and flu. It contains several active ingredients: acetaminophen (a pain reliever and fever reducer), dextromethorphan HBr (a cough suppressant), guaifenesin (an expectorant that helps loosen mucus), and phenylephrine HCl (a nasal decongestant). Together, these ingredients work to alleviate minor aches and pains, sinus and nasal congestion, sore throat, fever, headache, and cough, while promoting easier breathing and helping to clear mucus from the airways.

This product is intended to provide relief from the discomfort of cold and flu symptoms, making it easier for you to feel better and breathe more freely.

Uses

You can use this medication to temporarily relieve symptoms associated with the common cold and flu. It helps ease minor aches and pains, sinus congestion and pressure, nasal congestion, sore throat, fever, headache, and cough caused by minor throat and bronchial irritation.

Additionally, this medication promotes easier breathing through the nose and helps with nasal and sinus drainage. It also works to loosen phlegm (mucus) and thin bronchial secretions, making it easier to clear out bothersome mucus and making coughs more productive. Furthermore, it reduces swelling in the nasal passages, providing you with more comfort during your illness.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. For adults and children aged 12 years and older, you should take 2 caplets with a glass of water every 4 hours as needed. However, make sure not to exceed 8 caplets in a 24-hour period.

If you are considering giving this medication to a child under 12 years old, it's best to consult with a doctor first to determine the appropriate dosage. Always remember to take only the amount directed to avoid any potential risks.

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 whether a medication contains acetaminophen, please consult 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 if you have stopped taking an MAOI within the last two weeks. If you are uncertain about your medications, it's important to ask a healthcare professional.

Lastly, do not use this product if you have ever experienced an allergic reaction to it or any of its ingredients. Your safety is important, so please follow these guidelines carefully.

Side Effects

This product contains acetaminophen, which can lead to severe liver damage if you exceed 4,000 mg in 24 hours, take it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Additionally, be aware that acetaminophen may cause serious skin reactions, such as blisters, rash, or skin reddening. If you experience any of these symptoms, stop using the product and seek medical help immediately.

You should also consult a doctor if you have a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting. It's important to stop using the product and seek medical advice if you experience nervousness, dizziness, sleeplessness, worsening pain, or new symptoms. If you have liver disease, thyroid disease, diabetes, heart disease, high blood pressure, or other specific health conditions, talk to your doctor before using this product.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 4,000 mg in 24 hours, use it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as blisters or rashes. If you notice any skin issues, 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 your doctor promptly.

Before using this product, it's important to talk to your doctor if you have any of the following conditions: liver disease, thyroid disease, diabetes, heart disease, high blood pressure, difficulty urinating due to prostate enlargement, or a persistent cough. If you are taking the blood thinner warfarin, consult your doctor or pharmacist before use. If you experience symptoms like nervousness, dizziness, or worsening pain and cough, or if new symptoms arise, stop taking the product and call your doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately, even if you don't notice any symptoms.

Overdose

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

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t wait—get help right away. Remember, acting quickly can make a significant difference in the outcome.

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

If you are considering this medication for your child, it's important to consult with a doctor if your child is under 12 years old. For those aged 12 and older, the recommended dosage is 2 caplets taken with water every 4 hours, but be sure not to exceed 8 caplets in a 24-hour period.

In the event of an overdose, seek medical help immediately, even if your child shows no signs or symptoms. It's always better to be cautious when it comes to your child's health.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 4,000 mg of acetaminophen in a 24-hour period, using it alongside other medications that also contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product can lead to severe liver damage.

Before using this product, you should consult your doctor if you have liver disease. They can provide guidance on safe usage and any necessary adjustments to your dosage. Your health and safety are paramount, so don’t hesitate to seek professional advice.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, ideally around 25°C (77°F). It can safely be kept in a range from 15° to 30°C (59° to 86°F). Always check the outer package before use; if it is opened or if the blister is torn or broken, do not use the product. Additionally, make sure to look at the end flap for the expiration date and lot number to confirm its validity.

By following these simple storage and handling guidelines, you can help maintain the product's effectiveness and safety.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 2 caplets with water every 4 hours. If your child is under 12 years old, consult a doctor for the appropriate dosage.

If you are pregnant or breastfeeding, it's important to speak with a healthcare professional before using this medication. Additionally, parents should be aware of the potential for medicine abuse among teens and can find more information at www.StopMedicineAbuse.org.

FAQ

What is Walgreens Day Severe Cold & Flu?

Walgreens Day Severe Cold & Flu is a maximum strength medication that compares to the active ingredients in Vicks® DayQuil® Severe Cold & Flu, available in 24 caplets.

What are the active ingredients in this medication?

The active ingredients include acetaminophen (325 mg) for pain relief and fever reduction, dextromethorphan HBr (10 mg) as a cough suppressant, guaifenesin (200 mg) as an expectorant, and phenylephrine HCl (5 mg) as a nasal decongestant.

What symptoms does this medication relieve?

It temporarily relieves common cold and flu symptoms such as minor aches and pains, sinus and nasal congestion, sore throat, fever, headache, and cough due to minor throat and bronchial irritation.

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

Adults and children 12 years and over should take 2 caplets with water every 4 hours, not exceeding 8 caplets in 24 hours.

Are there any contraindications for this medication?

Do not use this product if you are taking any other drug containing acetaminophen, if you are on a prescription monoamine oxidase inhibitor (MAOI), or if you have had an allergic reaction to this product or its ingredients.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately, as prompt medical attention is critical.

What precautions should I take before using this medication?

Ask a doctor before use if you have liver disease, thyroid disease, diabetes, heart disease, high blood pressure, or difficulty urinating due to prostate enlargement.

Is this medication safe during pregnancy or breastfeeding?

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

What should I do if I experience severe side effects?

Stop use and consult a doctor if you experience nervousness, dizziness, sleeplessness, or if symptoms worsen or new symptoms occur.

Where can I find more information about this product?

For more information, visit walgreens.com or contact Walgreen Co. at their Deerfield, IL location.

Packaging Info

Below are the non-prescription pack sizes of Cold and Flu (acetaminophen, dextromethorphan hbr, guaifenesin, 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

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, including minor aches and pains, sinus congestion and pressure, nasal congestion, sore throat, fever, headache, and cough due to minor throat and bronchial irritation.

Additionally, this drug temporarily restores freer breathing through the nose, promotes nasal and/or sinus drainage, and helps to loosen phlegm (mucus) and thin bronchial secretions, thereby facilitating the clearance of bothersome mucus from the bronchial passageways and making coughs more productive. It also reduces swelling of the nasal passages.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the maximum daily limit. For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours, with a maximum of 8 caplets within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

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, as this may lead to serious drug interactions. Patients should verify the presence of MAOIs in their current medications with a healthcare provider if unsure.

  • History of allergic reactions to this product or any of its ingredients, as this may result in severe hypersensitivity reactions.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver injury may occur if they exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while using this product.

Patients should be alerted to the potential for severe skin reactions associated with acetaminophen. Symptoms such as blisters, rash, and skin reddening may indicate a serious allergic reaction. In the event of any skin reaction, patients must 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 be advised to consult a physician promptly.

General precautions should be taken for patients with specific health conditions. Prior to use, patients should be instructed to consult a healthcare provider if they have liver disease, thyroid disease, diabetes, heart disease, high blood pressure, difficulty urinating due to prostate enlargement, or a cough associated with excessive phlegm. Additionally, those with a persistent or chronic cough, such as that caused by smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before using this product. It is also essential to consult a doctor or pharmacist if the patient is taking warfarin, a blood-thinning medication.

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 whether symptoms are present.

Patients must be instructed to discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if new symptoms arise; if fever worsens or lasts more than three days; if redness or swelling occurs; or if a cough recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, including serious warnings related to liver health and allergic reactions. The product contains acetaminophen, which can lead to severe liver damage if the following conditions are met: exceeding 4,000 mg of acetaminophen in a 24-hour period, using other medications that also contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product.

Severe skin reactions have been reported in patients allergic to acetaminophen. Symptoms may include blisters, rash, and skin reddening. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious 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, as these may indicate a more serious condition requiring prompt medical consultation.

Common adverse reactions that warrant discontinuation of use and consultation with a healthcare provider include nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts longer than seven days, or if new symptoms arise, patients should seek medical advice. A fever that worsens or lasts more than three days, the presence of redness or swelling, or a cough that recurs or is accompanied by a rash or headache lasting beyond a reasonable duration may also signal a serious condition.

Patients with pre-existing conditions should consult a healthcare provider before using this product if they have liver disease, thyroid disease, diabetes, heart disease, high blood pressure, difficulty urinating due to prostate enlargement, or a cough associated with excessive phlegm. Furthermore, individuals taking the blood-thinning medication warfarin should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Cold and Flu.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours, with a maximum limit of 8 caplets within a 24-hour period.

In the event of an overdose, it is essential to seek prompt medical attention for both adults and children, even if no signs or symptoms are immediately apparent.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. 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 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 absence of guidance necessitates careful clinical judgment and monitoring.

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 that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid concurrent use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks per day while using this product is strongly discouraged, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during 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 the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate interventions as necessary.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified rare cases of severe skin reactions associated with the use of acetaminophen. These reactions include blisters, rash, and skin reddening. In the event of a skin reaction, users are advised to discontinue use and seek medical assistance immediately.

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 or go to the nearest emergency room 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 and safety of the patient.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). For reference, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients should be informed that the medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets taken with water every 4 hours. For children under 12 years, it is advised to consult a doctor before use.

Clinicians should counsel patients regarding the use of this medication during pregnancy or breastfeeding, recommending that they consult a health professional prior to use. Additionally, parents are encouraged to educate themselves about the potential for medicine abuse among teens 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)

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

Last AI update:

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.