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Walgreens

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Active ingredients
  • Acetaminophen 650 mg/30 mL
  • Dextromethorphan Hydrobromide 20 mg/30 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
December 1, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 650 mg/30 mL
  • Dextromethorphan Hydrobromide 20 mg/30 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Liquid
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 2025
Label revision date
December 1, 2025
Manufacturer
WALGREENS CO.
Registration number
M012
NDC root
0363-8100
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 Cold, Cough & Flu Relief is a medication designed to help you feel better when you're suffering from cold or flu symptoms. It contains acetaminophen (a pain reliever and fever reducer) and dextromethorphan HBr (a cough suppressant), which work together to temporarily relieve minor aches and pains, headaches, coughs, and sore throats. Additionally, it helps to reduce fever, making it a useful option for managing the discomfort associated with colds and flu.

This product is sugar-free and alcohol-free, and it comes in a pleasant natural cherry flavor. With its maximum strength formula, it aims to provide effective relief for your symptoms, helping you to feel more comfortable as you recover.

Uses

This medication is designed to help you feel better when you're dealing with the discomfort of a cold or flu. It can temporarily relieve minor aches and pains, headaches, coughs, and sore throats. If you're also experiencing a fever, this medication can help reduce it, providing you with some much-needed relief.

Additionally, if you have high blood pressure, you can still use this medication for cold relief without worrying about it affecting your condition. It's a convenient option to help manage those pesky symptoms and get you back on your feet.

Dosage and Administration

When using this medication, it's important to stick to the recommended dose to ensure your safety. If you are an adult or a child aged 12 years and older, you should take 30 mL using the dosing cup provided every 4 hours. However, make sure not to exceed 150 mL, which is equivalent to 5 doses, within a 24-hour period unless your doctor advises otherwise.

For children under 12 years of age, this medication is not suitable, so please do not use it for them. Always remember to take the medication orally, using the dosing cup to measure the correct amount. Following these guidelines will help you use the medication safely and effectively.

What to Avoid

You should avoid using this medication if you are currently taking any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist. Additionally, do not take this medication if you are on a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson's disease, or for two weeks after stopping an MAOI. If you are uncertain about your medications, it's important to ask a healthcare professional.

It's also crucial to avoid this medication if you have ever had an allergic reaction to it or any of its ingredients. Lastly, this product is not suitable for children under 12 years of age. Always prioritize your safety and consult with a healthcare provider if you have any questions or concerns.

Side Effects

You should be aware that taking more than 4,000 mg of acetaminophen in a 24-hour period, using it with other medications containing acetaminophen, or consuming three or more alcoholic drinks daily while using this product can lead to severe liver damage. Additionally, acetaminophen may cause serious allergic reactions, which can manifest as skin reddening, blisters, rashes, hives, facial swelling, asthma (wheezing), or even shock. If you experience any of these symptoms, stop using the product and seek medical help immediately.

It's also important to consult a doctor if you have a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. You should not use this product if you have had an allergic reaction to it or any of its ingredients. If your pain or cough worsens or lasts more than seven days, or if your fever worsens or lasts more than three days, you should stop using it and contact a healthcare professional.

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 or allergic reactions, such as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), or shock. 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 liver disease, a chronic cough (like from smoking or asthma), a cough with excessive mucus, or if you are on a sodium-restricted diet. If you are taking the blood thinner warfarin, check with your doctor or pharmacist first. If you have a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, contact your doctor promptly.

In case of an overdose, seek emergency medical help or contact a Poison Control Center right away, as quick attention is crucial. Stop using the product and call your doctor if your pain or cough worsens or lasts more than seven days, if your fever worsens or lasts more than three days, if you notice redness or swelling, if new symptoms appear, or if your cough returns with a rash or headache that persists. These could indicate a more serious condition.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. Quick action 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 hesitate to get help right away. Remember, acting quickly can make a significant difference in ensuring safety and health.

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

It's important to be cautious when considering this medication for children. You should not use it in children under 12 years of age. For those aged 12 and older, the recommended dosage is 30 mL taken every 4 hours, using the dosing cup provided. However, make sure not to exceed 150 mL (which is 5 doses) in a 24-hour period unless directed by a doctor. Always consult with a healthcare professional if you have any questions or concerns about using this medication for your child.

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 for personalized advice. 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 may affect you 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 monitor your kidney function and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, which contains 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, please 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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20º to 25ºC (68º to 77ºF). This temperature range helps maintain the integrity and effectiveness of the device.

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 safety and compliance with local regulations.

Additional Information

No further information is available.

FAQ

What is Walgreens Cold, Cough & Flu Relief?

Walgreens Cold, Cough & Flu Relief is a maximum strength liquid medication that contains acetaminophen (650 mg) for pain relief and fever reduction, and dextromethorphan HBr (20 mg) as a cough suppressant.

What symptoms does this medication relieve?

It temporarily relieves symptoms due to a cold or flu, including minor aches and pains, headache, cough, and sore throat, and it also reduces 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, not exceeding 150 mL (5 doses) in 24 hours.

Can children under 12 use this medication?

No, this medication should not be used in children under 12 years of age.

What should I do if I experience severe allergic reactions?

If you experience symptoms like skin reddening, blisters, rash, hives, or facial swelling, stop use and seek medical help immediately.

What precautions should I take if I have liver disease?

If you have liver disease, ask a doctor before using this product, as severe liver damage may occur with high doses of acetaminophen.

Is this product safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using this medication.

What should I do in case of an overdose?

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

What are the storage conditions for this medication?

Store Walgreens Cold, Cough & Flu Relief between 20º to 25ºC (68º to 77ºF).

Packaging Info

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

Packaging configurations for Walgreens.
Details

Drug Information (PDF)

This file contains official product information for Walgreens, 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 drug.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or influenza, including minor aches and pains, headache, cough, and sore throat. It also serves to temporarily reduce fever. Additionally, this medication provides relief from sore throat, fever, headache, cough, and body aches and pains.

This drug is suitable for cold relief in patients with high blood pressure. There are no teratogenic or nonteratogenic effects associated with this medication.

Dosage and Administration

The recommended dosage for adults and children aged 12 years and over is 30 mL, administered orally using the dosing cup provided, every 4 hours. It is imperative that the total daily dosage does not exceed 150 mL, which corresponds to a maximum of 5 doses within a 24-hour period, unless otherwise directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended. Healthcare professionals should ensure that patients adhere strictly to the prescribed dosage and frequency to avoid potential overdose.

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

  • In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions. Verify the presence of MAOIs in prescription medications with a healthcare provider if unsure.

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

  • In children under 12 years of age, due to safety concerns and lack of established efficacy in this population.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum recommended dosage is 4,000 mg of acetaminophen within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications containing acetaminophen or consuming three or more alcoholic beverages daily while taking this product.

Patients should be made aware of the potential for severe allergic reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of any skin or general allergic reaction, patients must discontinue use immediately and seek medical assistance.

Healthcare providers should also emphasize the importance of consulting a physician if patients 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 into account before recommending this product. Patients with liver disease, persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), cough accompanied by excessive phlegm, or those on a sodium-restricted diet should be advised to consult a physician prior to use. Additionally, patients taking the anticoagulant warfarin should seek guidance from a healthcare professional or pharmacist before using this product.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and consult a physician if any of the following occur: worsening pain or cough lasting more than seven days, fever worsening or persisting beyond three days, presence of redness or swelling, emergence of new symptoms, or recurrence of cough accompanied by rash or headache lasting. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed 4,000 mg of acetaminophen within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin or allergic reactions associated with acetaminophen. Symptoms of such reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Additionally, if a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is important to consult a healthcare professional promptly.

Patients should not use this product if they have a history of allergic reactions to acetaminophen or any of its ingredients. Furthermore, they are advised to stop use and consult a doctor if pain or cough worsens or lasts longer than seven days, if fever worsens or persists for more than three days, if redness or swelling is present, if new symptoms arise, or if a cough recurs or occurs with a rash or headache that lasts. These symptoms may indicate a serious condition requiring medical evaluation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 Walgreens (acetaminophen, dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Walgreens.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 30 mL taken in the dosing cup provided every 4 hours. The total daily dosage should not exceed 150 mL (5 doses) within a 24-hour period, unless otherwise directed by a healthcare professional.

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.

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 not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations for this medication. As such, there is no available information regarding the use of this drug in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the recommended dosage of 4,000 mg of acetaminophen within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with known liver disease consult a healthcare professional prior to using this product. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects associated with acetaminophen use.

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, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

No relevant information was found regarding teratogenic effects, non-teratogenic effects, or any other nonclinical toxicology data. Additionally, there is no available information pertaining to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is important to instruct patients not to use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be advised against its use. Additionally, this medication is not recommended for children under 12 years of age.

Patients should be instructed to stop using the medication and consult a doctor if their pain or cough worsens or persists for more than 7 days, if their fever worsens or lasts more than 3 days, or if they notice any redness or swelling. They should also seek medical advice if new symptoms arise or if a cough recurs, particularly if accompanied by a rash or headache that lasts, as these may indicate a serious condition.

Patients with liver disease, a persistent or chronic cough (such as that associated with smoking, asthma, or emphysema), or a cough accompanied by excessive phlegm should be advised to consult a doctor before using this medication. Furthermore, patients on a sodium-restricted diet or those taking the blood-thinning medication warfarin should also seek guidance from their healthcare provider or pharmacist prior to use.

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 20º to 25ºC (68º to 77ºF) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Walgreens, 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 Walgreens, 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.