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Cvs Maximum Strength Cold and Flu Relief

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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
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 2021
Label revision date
December 10, 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
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 2021
Label revision date
December 10, 2025
Manufacturer
CVS PHARMACY
Registration number
M012
NDC root
69842-903
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

CVS Maximum Strength Mucus Relief Cold, Flu is a medication designed to temporarily relieve symptoms associated with the common cold and flu. It helps alleviate cough, nasal congestion, minor aches and pains, sore throat, sinus congestion and pressure, and headaches. Additionally, it can reduce fever and promote nasal or sinus drainage. This product works by loosening phlegm (mucus) and thinning bronchial secretions, making coughs more productive.

The active ingredients include acetaminophen, which acts as a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; guaifenesin, an expectorant that helps clear mucus; and phenylephrine HCl, a nasal decongestant. This combination helps you feel more comfortable when dealing with cold and flu symptoms.

Uses

If you're dealing with the discomfort of a cold or flu, this medication can help. It temporarily relieves common symptoms such as cough, nasal congestion, minor aches and pains, sore throat, sinus congestion and pressure, and headaches. Additionally, it can help reduce fever and promote drainage from your nasal passages and sinuses.

This medication also works to loosen phlegm (a type of mucus) and thin bronchial secretions, making it easier to clear out bothersome mucus and making your coughs more productive. With these benefits, you can find some relief and feel better while your body fights off the illness.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety. You should not take more than the recommended amount, which is 20 mL every 4 hours for adults and children aged 12 years and older. Make sure to use the dosing cup provided with the medication to measure your dose accurately. Avoid using this cup for any other products to prevent confusion.

If you are caring for children under 12 years of age, do not use this medication for them. Additionally, remember that you should not exceed 6 doses in a 24-hour period. Always adhere to these guidelines to avoid any potential overdose. If you have any questions or concerns, consult your doctor for further advice.

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, this medication is not suitable for children under 12 years of age.

It's also important not to use this medication if you are taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of drug used for depression, psychiatric conditions, or Parkinson's disease. You should wait at least two weeks after stopping an MAOI before using this product. If you have any questions about your medications, don't hesitate to reach out to a healthcare professional for guidance.

Side Effects

Taking this medication can lead to some serious side effects, so it's important to be aware of them. You should avoid using it if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate. Additionally, do not take this medication with any other products containing acetaminophen, and avoid it if you are currently on a monoamine oxidase inhibitor (MAOI) or have taken one in the last two weeks.

Be cautious of severe skin reactions, which may include blisters or rashes. If you notice any skin issues, stop using the medication and seek medical help immediately. If you experience nervousness, dizziness, sleeplessness, or if your symptoms worsen or new symptoms appear, contact your doctor. It's also important to consult a healthcare professional if you have a severe sore throat that lasts more than two days or is accompanied by other concerning symptoms. Always follow the recommended dosage and consult a doctor if you have any questions or concerns.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you exceed 6 doses in 24 hours, take it with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using it. It's important to be aware of potential severe skin reactions, such as blisters or rashes. If you notice any skin reactions, stop using the product and seek medical help immediately.

If you have a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor right away. Additionally, you should stop using this product and contact your doctor if you experience nervousness, dizziness, or sleeplessness, if your pain, nasal congestion, or cough worsens or lasts more than 7 days, if your fever worsens or lasts more than 3 days, or if you notice redness or swelling. New symptoms or a cough that returns with a rash or persistent headache could indicate a serious condition, so it's best to seek medical advice.

Overdose

Taking more than 6 doses of this medication in a 24-hour period can lead to severe liver damage. It's also important to be cautious if you are using other medications that contain acetaminophen, as combining them can increase the risk of liver harm. Additionally, consuming 3 or more alcoholic drinks each day while using this product can also result in serious liver issues.

If you suspect an overdose, look for signs such as nausea, vomiting, loss of appetite, confusion, or jaundice (yellowing of the skin or eyes). If you experience any of these symptoms or believe you have taken too much, seek immediate medical help. It's always better to be safe and get checked by a healthcare professional.

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 for anyone under 12 years of age. For those who are 12 years and older, the recommended dosage is 20 mL taken every 4 hours using the dosing cup provided.

Always follow these guidelines to ensure the safety and well-being of your child. If you have any questions or concerns about using this medication, consult with a healthcare professional.

Geriatric Use

When considering medication use for older adults, it's important to consult with a doctor, especially if you or your loved one has any existing health conditions. This includes liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or issues with urination due to an enlarged prostate. These conditions can affect how the medication works and may require special attention.

Fortunately, there are no specific dosage adjustments or safety concerns noted for elderly patients in the information provided. However, always prioritize open communication with healthcare providers to ensure safe and effective treatment tailored to individual health 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 problems, it's important to be cautious when using this product, which contains acetaminophen. To avoid severe liver damage, do not exceed 6 doses in a 24-hour period, as this is the maximum daily amount. Additionally, avoid taking other medications that also contain acetaminophen and limit alcohol consumption to less than 3 drinks per day while using this product.

Before using this medication, please consult your doctor if you have liver disease. They can provide guidance tailored to your specific health needs and help ensure your safety while using this product.

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 at room temperature. It's important to avoid refrigerating it, as this can affect its effectiveness. When handling the product, make sure to do so in a clean environment to maintain its integrity and safety. Always follow any additional instructions provided with the product for optimal use.

Additional Information

You should take this medication orally, using the provided dosing cup. For adults and children aged 12 and older, the recommended dose is 20 mL every 4 hours. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. Additionally, make sure to keep it out of reach of children to ensure their safety.

FAQ

What symptoms does CVS Maximum Strength Mucus Relief Cold, Flu relieve?

It temporarily relieves common cold and flu symptoms including cough, nasal congestion, minor aches and pains, sore throat, sinus congestion and pressure, headache, and reduces fever.

What is the recommended dosage for adults and children 12 years and older?

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

Can children under 12 years of age use this product?

No, this product should not be used for children under 12 years of age.

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 are the liver warnings associated with this product?

Severe liver damage may occur if you take more than 6 doses in 24 hours, use with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Should I consult a doctor before using this product?

Yes, you should ask a doctor before use if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland.

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

Stop use and consult a doctor if nervousness, dizziness, or sleeplessness occur, or if pain, nasal congestion, or cough worsens or lasts more than 7 days.

Is it safe to use this product while pregnant or breastfeeding?

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

How should I store this product?

Store at room temperature and do not refrigerate.

Packaging Info

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

Packaging configurations for Cvs Maximum Strength Cold and Flu Relief.
Details

Drug Information (PDF)

This file contains official product information for Cvs Maximum Strength Cold and Flu Relief, 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 cough, nasal congestion, minor aches and pains, sore throat, sinus congestion and pressure, and headache. It also temporarily reduces fever and promotes nasal and/or sinus drainage. Additionally, this drug helps to loosen phlegm (mucus) and thin bronchial secretions, 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

Patients should adhere strictly to the recommended dosage and administration guidelines to ensure safety and efficacy.

For adults and children aged 12 years and older, the recommended dose is 20 mL, to be measured using the dosing cup provided, every 4 hours as needed. It is imperative that no more than 6 doses are taken within a 24-hour period.

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

Healthcare professionals should instruct patients to measure the dose only with the dosing cup included with the product and to avoid using this cup with any other medications to prevent dosing errors. Patients should also be advised not to exceed the directed dosage, as outlined in the Overdose Warning.

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 children under 12 years of age, as safety and efficacy have not been established in this population.

  • In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

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 to adhere strictly to the following precautions:

Liver Warning Severe liver damage may occur if the patient exceeds 6 doses within a 24-hour period, which is the maximum recommended daily amount. Additionally, the risk increases if the product is taken concurrently with other medications containing acetaminophen or if the patient consumes 3 or more alcoholic drinks daily while using this product. It is essential to monitor liver function in patients who may be at risk.

Allergy Alert Acetaminophen has the potential to cause severe skin reactions. Symptoms may manifest as skin rashes, blisters, or other dermatological issues. Should any skin reaction occur, patients must be instructed to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly. This may indicate a more serious underlying condition.

Additional Precautions Patients should be instructed to stop use and consult a doctor if they experience any of the following:

  • Nervousness, dizziness, or sleeplessness

  • Worsening pain, nasal congestion, or cough lasting more than 7 days

  • Fever that worsens or lasts more than 3 days

  • Presence of redness or swelling

  • Onset of new symptoms

  • Recurrence of cough, especially if accompanied by a rash or persistent headache

These symptoms may signify a serious condition requiring further evaluation and intervention. Regular monitoring and patient education on these warnings are crucial for safe use of this product.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of six doses within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware that acetaminophen may cause severe skin reactions, which can manifest as skin blisters or rashes. 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.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. It is contraindicated for children under 12 years of age and for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients uncertain about the presence of an MAOI in their prescription should consult a doctor or pharmacist prior to use.

Patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or those experiencing difficulty urinating due to an enlarged prostate gland should seek medical advice before using this product. Additionally, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also consult a healthcare provider. Those taking the blood-thinning medication warfarin should ask a doctor or pharmacist before use.

While using this product, patients must adhere to the directed dosage and should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. They should also seek medical advice if pain, nasal congestion, or cough worsens or persists beyond seven days, if fever worsens or lasts more than three days, if redness or swelling occurs, if new symptoms develop, or if a cough recurs with a rash or persistent headache, as these may indicate a serious condition.

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 Cvs Maximum Strength Cold and Flu Relief (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cvs Maximum Strength Cold and Flu Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage is 20 mL, administered every 4 hours using the dosing cup provided. Safety and efficacy have not been established in children younger than 12 years.

Geriatric Use

Elderly patients may not require specific dosage adjustments or exhibit unique safety concerns based on the available data. However, it is essential for healthcare providers to exercise caution and consider the overall health status of geriatric patients when prescribing this medication.

Particular attention should be given to patients with pre-existing conditions, as it is advised that individuals consult their healthcare provider prior to use if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulties with urination due to an enlarged prostate gland. These conditions may be more prevalent in the elderly population and could influence the safety and efficacy of the treatment. Regular monitoring and assessment of these factors are recommended to ensure optimal care for geriatric patients.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 with urination 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 6 doses within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

It is also advised that patients with hepatic impairment refrain from consuming 3 or more alcoholic drinks daily while using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with a history of liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of acetaminophen beyond the recommended limits.

Risk of Severe Liver Damage Administration of more than six doses within a 24-hour period, which exceeds the maximum daily dosage, poses a substantial risk of severe liver damage. Healthcare professionals should be vigilant in monitoring patients who may have inadvertently exceeded this threshold.

Additionally, the concomitant use of acetaminophen with other medications that also contain acetaminophen can lead to similar adverse effects. It is crucial for healthcare providers to assess a patient's complete medication history to prevent unintentional overdosing.

Alcohol Consumption Considerations Patients who consume three or more alcoholic beverages daily while using acetaminophen are at an increased risk for severe liver damage. Healthcare professionals should advise patients on the potential dangers of combining alcohol with acetaminophen and recommend moderation or abstinence from alcohol during treatment.

Management Procedures In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare providers should initiate appropriate management protocols, which may include monitoring liver function tests and considering the administration of N-acetylcysteine as an antidote, depending on the severity of the overdose and the time elapsed since ingestion. Prompt intervention is essential to mitigate the risk of irreversible liver injury.

Nonclinical Toxicology

No relevant information was found regarding teratogenic effects, non-teratogenic effects, or any other aspects of nonclinical toxicology. Additionally, there are no findings related to animal pharmacology and toxicology.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to communicate that this product is not recommended for children under 12 years of age. Additionally, patients should be cautioned against using this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be advised to seek clarification from a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. They should also be advised to stop using the product and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than 7 days, or if fever worsens or lasts more than 3 days. Any signs of redness or swelling, new symptoms, or a cough that returns or occurs with a rash or persistent headache should prompt patients to contact their healthcare provider, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. It is essential for patients to consult a doctor before use 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 with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice before using this product. Furthermore, patients should be advised to consult a doctor or pharmacist if they are taking the blood-thinning medication warfarin.

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 room temperature, ensuring that it is not exposed to refrigeration. Proper handling should be observed to maintain the integrity of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older, using the dosing cup provided. Clinicians should advise patients to consult a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Cvs Maximum Strength Cold and Flu Relief, 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 Cvs Maximum Strength Cold and Flu Relief, 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.