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Cold and Flu

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Active ingredients
  • Acetaminophen 650 mg/20 mL
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
  • Phenylephrine Hydrochloride 10 mg/20 mL
Other brand names
Drug classes
Expectorant, 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 2023
Label revision date
October 27, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 650 mg/20 mL
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
  • Phenylephrine Hydrochloride 10 mg/20 mL
Other brand names
Drug classes
Expectorant, 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 2023
Label revision date
October 27, 2025
Manufacturer
Walgreen Company
Registration number
M012
NDC root
0363-9042
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

This product is a Maximum Strength Cold & Flu remedy distributed by Walgreens, designed to help relieve a variety of common cold and flu symptoms. 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).

By temporarily alleviating symptoms such as nasal congestion, cough, sore throat, and minor aches, this medication aims to make you feel more comfortable when you're under the weather. It also helps reduce fever and makes coughs more productive by thinning bronchial secretions, allowing you to clear mucus from your airways more easily.

Uses

If you're dealing with the discomfort of a cold or flu, this medication can help. It temporarily relieves common symptoms such as nasal congestion, a stuffy nose, minor aches and pains, headaches, coughs, sore throats, and sinus congestion and pressure. Additionally, it can help reduce fever, making you feel more comfortable as you recover.

This medication also works to loosen phlegm (mucus) and thin bronchial secretions, which can help clear your airways and make your coughs more productive. This means you can breathe easier and get back to feeling like yourself sooner.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. You should not take more than the directed amount, and make sure not to exceed 6 doses within a 24-hour period. Always use the dosing cup that comes with the medication to measure your dose accurately.

For adults and children aged 12 years and older, the recommended dose is 20 mL, taken every 4 hours as needed. However, if you have a child under 12 years old, this medication is not suitable for them, and you should not use it. Always remember to adhere to these guidelines for the best results.

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 if you have stopped taking an MAOI within the last two weeks. If you have a history of allergic reactions to this product or any of its ingredients, you should also refrain from using it.

While using this product, make sure not to exceed the recommended dosage. It's important to be cautious, as misuse or abuse of medications can lead to serious health issues, including dependence (a condition where your body becomes reliant on a substance). Always prioritize your safety and well-being by following these guidelines.

Side Effects

You should be aware of some important warnings and potential side effects associated with this product. It contains acetaminophen, which can lead to severe liver damage if you exceed 4,000 mg in 24 hours, consume three or more alcoholic drinks daily while using it, or take other medications that also contain acetaminophen. Additionally, 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.

It's also important to 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. You should stop using the product and contact a healthcare professional if your pain, nasal congestion, or cough worsens or lasts more than seven days, if you develop new symptoms, or if you experience nervousness, dizziness, or sleeplessness. Always talk to your doctor before using this product if you have certain health conditions, such as liver disease, heart disease, or diabetes, or if you are taking blood thinners like warfarin.

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, consume three or more alcoholic drinks daily while using it, or combine it with other medications that also contain acetaminophen. Be aware that acetaminophen may cause serious skin reactions, such as blisters, rash, or skin reddening. If you experience any skin reactions, stop using the product and seek medical help immediately. Additionally, 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: diabetes, liver disease, heart disease, thyroid disease, high blood pressure, or difficulty urinating due to prostate enlargement. If you are taking the blood thinner warfarin, consult your doctor or pharmacist before use. If you suspect an overdose, seek emergency medical help or contact a Poison Control Center right away, even if you don't notice any symptoms.

You should stop using this product and call your doctor if your pain, nasal congestion, or cough worsens or lasts more than seven days, if new symptoms develop, or if you experience nervousness, dizziness, sleeplessness, or a fever that lasts more than three days. Redness or swelling, or a cough that returns with a rash or headache, may indicate a serious condition, and you should seek medical advice.

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 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 know that this medication should not be used in children under 12 years old. For those aged 12 and older, the recommended dose is 20 mL taken every 4 hours using the dosing cup provided.

If you are caring for a child or an adult taking this medication, be aware that seeking prompt medical attention is crucial, even if there are no noticeable signs or symptoms. Always prioritize safety and follow the dosing guidelines carefully.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

Renal Impairment

If you have kidney issues, it's important to consult your doctor before using this medication, especially if you experience difficulty urinating due to an enlarged prostate gland. Additionally, if you are taking the blood thinner warfarin, make sure to discuss this with your doctor or pharmacist before starting the medication. Your healthcare provider can help ensure that your treatment is safe and effective given your specific health needs.

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 can lead to severe liver damage. Additionally, consuming three or more alcoholic drinks each day while using this product can also increase your risk of liver damage. Be sure to avoid using other medications that contain acetaminophen at the same time.

Before using this product, you should consult with 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 the top priority, 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 your overall treatment plan is safe and effective.

Always discuss any other medications, supplements, or health conditions you have, as this information is crucial for your safety and well-being. Your provider can guide you on how to manage your health effectively.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F). It can safely be kept within a range of 15°-30°C (59°-86°F) for short periods. Always check the expiration date on the package and use the product before this date to guarantee its effectiveness.

When handling the product, make sure to do so with clean hands and in a safe environment to maintain its integrity. Proper storage and careful handling are key to ensuring your product remains safe and effective for use.

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. Always keep this medication out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center immediately, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

FAQ

What is the main use of this product?

This product is used to temporarily relieve common cold and flu symptoms such as nasal congestion, cough, sore throat, and minor aches and pains.

Who is this product recommended for?

It is recommended for individuals 12 years and older.

What should I do if I experience severe skin reactions?

If you experience severe skin reactions such as blisters or rash, stop use and seek medical help immediately.

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

The recommended dosage is 20 mL in the dosing cup provided every 4 hours, not to exceed 6 doses in any 24-hour period.

Are there any contraindications for this product?

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.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

Can I use this product if I am pregnant or breastfeeding?

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

What are the storage instructions for this product?

Store at 25°C (77°F); excursions are permitted between 15°-30°C (59°-86°F).

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

Stop use and ask a doctor if pain, nasal congestion, or cough gets worse or lasts more than 7 days, or if new symptoms occur.

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 common cold and flu symptoms, including nasal congestion, stuffy nose, minor aches and pains, headache, cough, sore throat, and sinus congestion and pressure. Additionally, it temporarily reduces fever and assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

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

Dosage and Administration

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

For adults and children aged 12 years and older, the recommended dose is 20 mL, to be measured using the dosing cup provided, administered every 4 hours as needed. It is imperative that patients do not exceed 6 doses within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended.

Patients should be instructed to utilize only the dosing cup provided to ensure accurate measurement and administration of the medication.

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

Severe liver damage may occur with the use of this product containing acetaminophen if the following conditions are met: exceeding 4,000 mg of acetaminophen within a 24-hour period, consuming three or more alcoholic drinks daily while using this product, or taking other medications that also contain acetaminophen.

Acetaminophen may also lead to severe skin reactions, which can manifest as blisters, rash, or skin reddening. 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 advised to seek medical advice if they have any of the following conditions: diabetes, a cough associated with excessive phlegm, liver disease, thyroid disease, heart disease, difficulty urinating due to prostate enlargement, high blood pressure, or a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients taking the anticoagulant warfarin should consult a healthcare professional or pharmacist before use.

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, regardless of the presence of symptoms.

Patients should discontinue use and contact a healthcare provider if any of the following occur: worsening pain, nasal congestion, or cough lasting more than seven days; the emergence of new symptoms; feelings of nervousness, dizziness, or sleeplessness; fever worsening or lasting more than three days; presence of redness or swelling; or a cough that recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

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

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

Additionally, acetaminophen may cause severe skin reactions, which can manifest as blisters, rash, or skin reddening. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

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

Patients should stop using the product and consult a doctor if they experience worsening pain, nasal congestion, or cough lasting more than seven days; new symptoms arise; nervousness, dizziness, or sleeplessness occur; fever worsens or lasts more than three days; redness or swelling is present; or if a cough recurs with a rash or headache that persists. These symptoms may indicate a serious condition.

Before using this product, patients should consult a doctor if they have diabetes, a cough associated with excessive phlegm, liver disease, thyroid disease, heart disease, difficulty urinating due to prostate enlargement, high blood pressure, or a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema.

Furthermore, patients 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 not use this medication. For adolescents aged 12 years and older, the recommended dosage is 20 mL, administered every 4 hours using the dosing cup provided.

It is essential for healthcare professionals to emphasize that prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

There is no specific information 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. 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 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 difficulty in urination due to enlargement of the prostate gland. Additionally, it is advisable for patients taking the blood-thinning medication warfarin to seek guidance from a doctor or pharmacist before initiating treatment. Monitoring and appropriate dosing adjustments may be necessary for individuals with reduced kidney function to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is critical that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, consumption of three or more alcoholic drinks daily while using this product is contraindicated, as it may exacerbate the risk of liver injury.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product. Monitoring of liver function may be warranted in these individuals to ensure safety and efficacy. It is essential for patients to disclose any history of liver problems to their healthcare provider to facilitate appropriate management and dosage adjustments if necessary.

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 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 care as needed.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which include blisters, rash, and skin reddening. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients on the importance of adhering to the recommended dosage and not exceeding it. Patients should be made aware that taking more than the prescribed amount can lead to serious health risks.

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

Storage and Handling

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

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

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.