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Cvs Maximum Strength Severe Congestion and Cough

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Active ingredients
  • 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)
Marketed in the U.S.
Since 2020
Label revision date
December 10, 2025
Active ingredients
  • 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
Marketed in the U.S.
Since 2020
Label revision date
December 10, 2025
Manufacturer
CVS PHARMACY, INC
Registration number
M012
NDC root
69842-767

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Drug Overview

CVS Maximum Strength Severe Congestion & Cough is a medication designed to help relieve symptoms associated with colds and respiratory irritants. It works by loosening phlegm (mucus) and thinning bronchial secretions, making it easier to clear your airways and produce a more effective cough. This product temporarily alleviates cough caused by minor throat and bronchial irritation, as well as nasal congestion.

The active ingredients include dextromethorphan HBr, which acts as a cough suppressant; guaifenesin, an expectorant that helps thin and loosen mucus; and phenylephrine HCl, a nasal decongestant that relieves nasal congestion. Together, these components help control coughing and relieve both nasal and chest congestion, providing you with some comfort during your illness.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. This action helps clear out bothersome mucus from your airways, making your coughs more productive.

You can also use this medication to temporarily relieve coughs caused by minor throat and bronchial irritation, which can happen with the common cold or from inhaling irritants. It helps reduce the intensity of your cough and can ease nasal congestion associated with a cold, allowing you to cough less frequently.

Dosage and Administration

It's important to follow the correct dosage when taking this medication to ensure your safety and effectiveness. For adults and children aged 12 years and older, you should take 20 mL using the dosing cup provided every 4 hours. Make sure to measure the dose accurately with the dosing cup that comes with the medication, as using a different cup could lead to incorrect dosing.

Remember, you should not take more than 6 doses within a 24-hour period. If you are giving this medication to someone under 12 years of age, do not use it at all. Always consult with your doctor if you have any questions or need further guidance on how to use this medication safely.

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, or emotional conditions, or Parkinson's disease. Additionally, you should not use this product for at least two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist before using this product.

It's also important to follow the dosage instructions carefully. Do not exceed the recommended amount when using this product, as misuse can lead to serious health issues. Always prioritize your safety and well-being by adhering to these guidelines.

Side Effects

If you experience nervousness, dizziness, or trouble sleeping while using this medication, it's important to stop and consult your doctor. Additionally, if your symptoms do not improve within 7 days, or if you develop a fever, persistent cough, rash, or a headache that lasts, these could indicate a more serious condition that requires medical attention.

Before using this medication, talk to your doctor if you have any of the following: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, or a chronic cough related to smoking, asthma, or other lung conditions. Also, avoid using this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one in the past two weeks, as this can lead to serious interactions.

Warnings and Precautions

You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

Before using this product, it's important to talk to your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, or a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. You should also seek medical help immediately if you suspect an overdose by contacting a Poison Control Center at (1-800-222-1222).

If you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within seven days or are accompanied by a fever, you should stop using the product and call your doctor. Additionally, if your cough returns or is accompanied by a rash or a persistent headache, these could be signs of a more serious condition, and you should seek medical advice.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. Your health and safety are the top priority.

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. If your child is under 12 years old, you should not use this product. For those aged 12 and older, the recommended dosage is 20 mL every 4 hours, using the dosing cup provided.

Always keep this medication out of reach of children. In the event of an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222. Your child's safety is paramount, so please follow these guidelines carefully.

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 considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always ensure that your healthcare provider is aware of any existing health conditions or medications, as this can help in making informed decisions about treatment options. Your safety and well-being are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

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 know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be cautious when taking certain medications together. If you are currently using a prescription monoamine oxidase inhibitor (MAOI), or if you have stopped taking one within the last two weeks, you should avoid using this medication. Combining these can lead to serious interactions that may affect your health.

Always discuss any medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. They can help ensure that your treatment is safe and effective, and they can provide guidance tailored to your specific health needs.

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 specific instructions provided for use to ensure optimal results.

Additional Information

You should take this medication orally, using the dosing cup provided. For adults and children aged 12 years and older, the recommended dose is 20 mL every 4 hours. However, this medication is not recommended for children under 12 years of age. If you have any questions about how to take this medication, be sure to consult your healthcare provider.

FAQ

What is CVS Maximum Strength Severe Congestion & Cough used for?

It helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and relieving cough due to minor throat and bronchial irritation.

What are the active ingredients in this medication?

The active ingredients are Dextromethorphan HBr (cough suppressant), Guaifenesin (expectorant), and Phenylephrine HCl (nasal decongestant).

Who should use this product?

It is intended for adults and children aged 12 years and older. Children under 12 years of age should not use it.

How should I take CVS Maximum Strength Severe Congestion & Cough?

You should take 20 mL in the dosing cup provided every 4 hours, but do not exceed 6 doses in a 24-hour period.

Are there any contraindications for this medication?

Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last 2 weeks.

What should I do if I experience side effects?

Stop use and ask a doctor if you experience nervousness, dizziness, sleeplessness, or if symptoms do not improve within 7 days.

Is it safe to use during pregnancy or breastfeeding?

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

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately at (1-800-222-1222).

Packaging Info

Below are the non-prescription pack sizes of Cvs Maximum Strength Severe Congestion and Cough (dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cvs Maximum Strength Severe Congestion and Cough.
Details

Drug Information (PDF)

This file contains official product information for Cvs Maximum Strength Severe Congestion and Cough, 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 relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and alleviates nasal congestion associated with colds. It is designed to help reduce the frequency of coughing episodes.

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

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. Healthcare professionals should instruct patients to measure the medication exclusively with the dosing cup provided, and to refrain from using this cup with any other products to ensure accurate dosing.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered every 4 hours as needed. It is imperative that patients do not exceed the specified dosage.

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

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Exceeding the recommended dosage while using this product is also contraindicated.

Warnings and Precautions

Patients should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Healthcare professionals should advise patients to seek medical guidance before using this product if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients with a cough that produces excessive phlegm (mucus) should also consult a healthcare provider before use.

In the event of an overdose, it is crucial to obtain emergency medical assistance immediately or contact a Poison Control Center at (1-800-222-1222).

Patients are advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, or if a cough recurs or is associated with a rash or persistent headache, these may indicate a serious condition requiring medical evaluation.

Side Effects

Patients may experience a range of adverse reactions while using this product. Serious adverse reactions warrant immediate medical attention and include symptoms such as nervousness, dizziness, or sleeplessness. Patients should discontinue use and consult a healthcare professional if these symptoms occur, if symptoms do not improve within 7 days, or if they are accompanied by fever. Additionally, a return of cough or the presence of a rash or persistent headache may indicate a serious underlying condition, necessitating medical evaluation.

Common adverse reactions may include those associated with pre-existing health conditions. Patients with heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland should seek medical advice before using this product. Furthermore, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also consult a healthcare provider prior to use. Coughs accompanied by excessive phlegm (mucus) should be evaluated by a doctor.

It is contraindicated to use this product in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should refrain from using this product while taking an MAOI or for 2 weeks following the cessation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, patients are advised to consult a healthcare professional or pharmacist before use.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on an MAOI or for a period of two weeks following the discontinuation of an MAOI. The combination may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, routine monitoring or dosage adjustments are not necessary beyond the contraindication noted above.

Packaging & NDC

Below are the non-prescription pack sizes of Cvs Maximum Strength Severe Congestion and Cough (dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cvs Maximum Strength Severe Congestion and Cough.
Details

Pediatric Use

Children under 12 years of age should not use this medication. For adults and children aged 12 years and older, the recommended dosage is 20 mL, administered every 4 hours using the dosing cup provided.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at (1-800-222-1222).

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the 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 have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center without delay at (1-800-222-1222) for guidance on managing the situation.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and effective recovery.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs, including nervousness, dizziness, and sleeplessness. Additionally, it is noted that symptoms persisting beyond 7 days, or those accompanied by fever, a returning cough, or a rash, as well as a headache that endures, may indicate the presence of a serious condition.

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, patients should be instructed to seek medical help immediately or contact a Poison Control Center at (1-800-222-1222).

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 last two weeks. It is important for patients to consult with their doctor or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Healthcare providers should inform patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop using the product and seek medical advice if their symptoms do not improve within seven days or if they develop a fever. They should also be instructed to stop use and contact a doctor if their cough returns or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

Patients must be reminded to adhere to the recommended dosage and not exceed the directed amount while using this product.

Before initiating treatment, healthcare providers should encourage patients to discuss their medical history, particularly if they have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should consult their doctor prior to use. Lastly, patients experiencing a cough with excessive phlegm (mucus) should also seek medical advice before 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, 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. It is contraindicated for use in children under 12 years of age. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Cvs Maximum Strength Severe Congestion and Cough, 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 Severe Congestion and Cough, 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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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.