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Cvs Severe Cough, Flu Plus Sore Throat

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Active ingredients
  • Acetaminophen 650 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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
December 9, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 650 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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
December 9, 2025
Manufacturer
CVS PHARMACY
Registration number
M012
NDC root
51316-631
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

CVS SEVERE Daytime Cough, Flu Honey CF Max is a maximum strength liquid medication designed for individuals aged 12 and over. It contains key ingredients like acetaminophen (a pain reliever and fever reducer) and dextromethorphan HBr (a cough suppressant), which work together to temporarily relieve symptoms associated with the cold or flu. This includes alleviating cough due to throat and bronchial irritation, reducing minor aches and pains, soothing sore throat pain, and lowering fever.

In addition to its medicinal properties, this formulation includes honey and elderberry, providing a pleasant taste while helping to control cough and ease discomfort. It's a supportive option for managing the discomforts of cold and flu symptoms during the day.

Uses

This medication is designed to help you feel better when you're dealing with the discomforts of a cold or flu. It can temporarily relieve symptoms such as a cough caused by minor irritation in your throat and bronchial tubes, as well as minor aches and pains, sore throat pain, and headaches. Additionally, it can help reduce fever, making you more comfortable as you recover.

You can rely on this medication to ease these common symptoms, allowing you to rest and heal more effectively.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage carefully to ensure your safety. For adults and children aged 12 years and older, you should take 20 milliliters (ml) every 4 hours. However, make sure not to take more than 6 doses within a 24-hour period. Exceeding the recommended dosage can lead to serious liver damage, so it's crucial to stick to these guidelines.

To measure your dose accurately, use the dosing cup that comes with the product, and keep it handy for future use. Remember, this medication is not intended for children under 12 years of age, so please do not use it for younger individuals. Always prioritize your health by following these instructions closely.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson's disease. Additionally, do not take this product for at least two weeks after stopping an MAOI. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

It's also important not to use this product alongside any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you have any doubts about whether a drug contains acetaminophen, ask your healthcare provider. Lastly, always follow the dosing instructions carefully and do not exceed the recommended amount.

Side Effects

Taking this medication can lead to some serious side effects, particularly concerning your liver. You should avoid taking more than 6 doses in a 24-hour period, using it with other products that contain acetaminophen, or consuming 3 or more alcoholic drinks daily while on this medication, as these can increase the risk of severe liver damage.

Be aware that acetaminophen may also cause severe skin reactions, which can include symptoms like skin reddening, blisters, or rash. If you experience any of these, stop using the medication and seek medical help immediately. Additionally, if your pain or cough worsens or lasts more than 7 days, or if you develop a fever that lasts more than 3 days, it's important to consult a doctor. Always talk to your healthcare provider before using this medication if you have liver disease, a chronic cough, or if you are taking blood thinners or other pain relievers.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you exceed 6 doses in a 24-hour period, take it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Be aware that acetaminophen may cause serious skin reactions, such as skin reddening, blisters, or rash. If you experience any of these symptoms, stop using the product and seek medical help immediately. If you have a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly.

Before using this product, do not take it if you are currently on a prescription monoamine oxidase inhibitor (MAOI) or have taken one in the last 2 weeks. Avoid using it with any other medications that contain acetaminophen. Consult your doctor if you have liver disease, a cough with excessive mucus, or breathing issues related to smoking, asthma, or emphysema. If you are taking warfarin or any other pain reliever/fever reducer, check with your doctor or pharmacist first. Always follow the dosage instructions carefully.

In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately, as prompt attention is crucial. Stop using the product and call your doctor if your pain or cough worsens or lasts more than 7 days, if your fever persists for more than 3 days, or if you notice any new symptoms, redness, or swelling. 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. 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. Remember, prompt medical attention can make a significant difference, so don’t hesitate to reach out for help.

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

This product is specifically designed for adults and children aged 12 years and older. If your child is under 12, it is important not to use this medication. For those 12 and older, the recommended dosage is 20 ml every 4 hours as needed. Always ensure you follow these guidelines to keep your child safe and healthy.

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 this product, which contains acetaminophen. To avoid severe liver damage, do not exceed 6 doses in a 24-hour period, and be careful not to take other medications that also contain acetaminophen. Additionally, limit your alcohol intake to fewer than 3 drinks per day while using this product, as drinking more can increase the risk of 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 the top priority, so don’t hesitate to seek professional advice.

Drug Interactions

It's important to be aware that taking acetaminophen (a common pain reliever) alongside warfarin (a blood thinner) can increase the effects of warfarin, which raises the risk of bleeding. If you are using both medications, your healthcare provider may need to monitor your INR (a blood test that measures how long it takes your blood to clot) more closely to ensure your safety.

Always discuss any medications you are taking with your healthcare provider, including over-the-counter drugs like acetaminophen. This helps to prevent potential interactions and ensures that your treatment plan is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or other safety measures, please refer to the guidelines provided with your product.

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 CVS SEVERE Daytime Cough, Flu Honey CF Max used for?

It temporarily relieves symptoms associated with a cold or flu, including cough, minor aches and pains, sore throat pain, and headache.

What are the active ingredients in this product?

The active ingredients are acetaminophen, which is a pain reliever and fever reducer, and dextromethorphan HBr, which is a cough suppressant.

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

The recommended dosage is 20 ml every 4 hours, not to exceed 6 doses in a 24-hour period.

Are there any contraindications for using this product?

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) or any other drug containing acetaminophen.

What should I do if I experience severe skin reactions?

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

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center right away, as prompt medical attention is critical.

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

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

What are the storage instructions for this product?

Store at room temperature and keep out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Cvs Severe Cough, Flu Plus Sore Throat (acetaminophen, dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cvs Severe Cough, Flu Plus Sore Throat.
Details

Drug Information (PDF)

This file contains official product information for Cvs Severe Cough, Flu Plus Sore Throat, 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 cough due to minor throat and bronchial irritation, minor aches and pains, sore throat pain, and headache. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 20 ml every 4 hours as needed. It is imperative that no more than 6 doses are administered within a 24-hour period. Healthcare professionals should emphasize the importance of adhering to the recommended dosage, as exceeding this may result in serious liver damage.

The dosing cup provided with the product must be used for accurate measurement; it is essential to keep the dosing cup with the product at all times to ensure proper dosing. This product is not intended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, or within 2 weeks of discontinuing such medication. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, consultation with a healthcare professional is advised.

Concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription, is also contraindicated due to the risk of acetaminophen overdose. If there is doubt about the acetaminophen content of a medication, a healthcare professional should be consulted.

Additionally, it is essential to adhere to the recommended dosage and not exceed the directed use of this product.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 doses within a 24-hour period (the maximum daily amount), concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Consultation Requirements Healthcare professionals should advise patients to consult a doctor before using this product if they have liver disease, a cough accompanied by excessive phlegm, or any breathing problems, including chronic cough associated with smoking, asthma, or emphysema. Additionally, patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. If patients are uncertain whether their prescription includes an MAOI, they should seek clarification from a healthcare provider.

Patients should also be advised to consult a doctor or pharmacist before using this product if they are taking the anticoagulant warfarin or any other pain reliever or fever reducer. It is essential to adhere strictly to the recommended dosage and not exceed the directed amount.

Emergency Medical Help In the event of an 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 vital for both adults and children, even in the absence of noticeable symptoms.

Discontinuation of Use Patients should stop using this product and consult a doctor if any of the following occur: pain or cough worsens or persists beyond 7 days; fever worsens or lasts more than 3 days; redness or swelling is observed; new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

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 reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients are advised to stop use and consult a healthcare professional if pain or cough worsens or persists for more than seven days, if fever worsens or lasts longer than three days, if redness or swelling is observed, if new symptoms develop, or if a cough recurs alongside a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Individuals with liver disease, those experiencing a cough accompanied by excessive phlegm, or patients with breathing problems or chronic coughs related to smoking, asthma, or emphysema should consult a healthcare provider before using this product.

Additionally, patients taking the blood-thinning medication warfarin or any other pain reliever or fever reducer should seek advice from a doctor or pharmacist prior to use.

Drug Interactions

Acetaminophen has been observed to enhance the anticoagulant effects of warfarin, which may result in an elevated risk of bleeding. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients who are receiving both acetaminophen and warfarin concurrently to ensure safe therapeutic levels and to mitigate the risk of adverse effects.

No additional drug interactions or interactions with laboratory tests have been reported.

Packaging & NDC

Below are the non-prescription pack sizes of Cvs Severe Cough, Flu Plus Sore Throat (acetaminophen, dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cvs Severe Cough, Flu Plus Sore Throat.
Details

Pediatric Use

This product is not intended for use in pediatric patients under 12 years of age. For patients aged 12 years and older, the recommended dosage is 20 ml every 4 hours. There are no established safety or efficacy profiles for children under 12 years, and therefore, use in this population is contraindicated.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the 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 associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily amount of 6 doses within any 24-hour period. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

Patients with known liver disease are advised to consult a healthcare professional prior to use. Monitoring of liver function may be warranted in these individuals 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 attention is critical for both adults and children, regardless of whether any signs or symptoms are initially apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is essential to monitor the patient closely and provide appropriate interventions as necessary.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion.

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

Patients should also be instructed to adhere strictly to the recommended dosage and not to exceed the directed amount while using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

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 crucial 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 essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

This file contains official product information for Cvs Severe Cough, Flu Plus Sore Throat, 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 Severe Cough, Flu Plus Sore Throat, 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.

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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.