Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Cvs

Last content change checked dailysee data sync status

Active ingredients
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Expectorant, 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 10, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 400 mg/20 mL
  • Dextromethorphan Hydrobromide 20 mg/20 mL
Other brand names
Drug classes
Expectorant, 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 10, 2024
Manufacturer
CVS PHARMACY
Registration number
M012
NDC root
51316-740
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 Max Strength Dextromethorphan HBr and Guaifenesin is a medication designed for adults aged 12 and over to help relieve cough and chest congestion. It contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant to temporarily relieve cough caused by minor throat and bronchial irritation, and guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions, making it easier to drain the bronchial tubes.

This combination works effectively to control cough and relieve chest congestion, providing you with comfort during a cold or similar respiratory issues.

Uses

If you're dealing with a cough caused by minor irritation in your throat or bronchial tubes, especially from a cold, this medication can provide temporary relief. It works by soothing your throat and helping to ease the discomfort associated with coughing.

Additionally, this medication helps to loosen phlegm (mucus) and thin out bronchial secretions, making it easier for your body to clear out the mucus from your airways. This can be particularly helpful when you're feeling congested and need to drain your bronchial tubes.

Dosage and Administration

When using this medication, it's important to follow the dosing instructions carefully. For adults and children aged 12 years and older, you should take 20 milliliters (mL) every 4 hours, but make sure not to exceed 6 doses in a 24-hour period. To ensure accurate dosing, always use the dosing cup that comes with the product, and keep it handy for each use.

Please note that this medication is not suitable for children under 12 years of age, so do not give it to younger children. By following these guidelines, you can use the medication safely and effectively.

What to Avoid

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications often prescribed for depression, psychiatric conditions, or Parkinson’s disease. Additionally, do not use this product for at least two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, it's important to consult with your doctor or pharmacist before taking this product.

Taking this medication while on an MAOI can lead to serious health risks, so please prioritize your safety by following these guidelines closely.

Side Effects

If you experience a persistent cough, it could indicate a serious condition, so it's important to pay attention to this symptom. You should stop using the medication and consult your doctor if your cough lasts more than 7 days, returns after improvement, or is accompanied by other symptoms such as fever, rash, or a persistent headache. Taking these steps can help ensure your health and safety.

Warnings and Precautions

If you are taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, do not use this product. You should also wait at least two weeks after stopping an MAOI before using it. If you're unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.

It's important to be aware of your health while using this product. If your cough lasts more than seven days, returns, or is accompanied by a fever, rash, or a persistent headache, stop using the product and contact your doctor. These symptoms could indicate a more serious condition.

In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your safety is a priority, so please take these precautions seriously.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

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 medication for your child. This product is not recommended for children under 12 years old. If your child is 12 years or older, the appropriate dosage is 20 mL every 4 hours. Always ensure that you follow these guidelines to keep your child safe and healthy.

Geriatric Use

When considering this medication for older adults, it's important to note that the recommended dosage is 20 mL every 4 hours, with a maximum of 6 doses in a 24-hour period. This dosage applies to both adults and children aged 12 years and older. However, this product is not suitable for children under 12 years of age.

Since there are no specific guidelines provided for geriatric use, it's advisable to consult with a healthcare professional to ensure that this medication is appropriate for your individual health needs, especially if there are any concerns about kidney function or other age-related health changes. Always prioritize safety and seek guidance tailored to older adults.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This adjustment is based on your creatinine clearance levels, which is a measure of how well your kidneys are filtering waste from your blood. To ensure your safety, your renal function should be monitored regularly, starting with tests before you begin treatment and continuing periodically thereafter.

Regular monitoring helps your healthcare provider make informed decisions about your treatment plan. Always discuss any concerns with your doctor, as they can provide guidance tailored to your specific needs.

Hepatic Impairment

If you have liver problems, it's important to know that your condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Additionally, your healthcare provider will likely monitor your liver function tests (which check how well your liver is working) to keep an eye on your health while you are taking the medication. Special precautions will be taken when administering the drug to ensure your safety, so be sure to discuss any concerns with your doctor.

Drug Interactions

It's important to be cautious about combining medications. You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, certain psychiatric conditions, or Parkinson’s disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your current medication includes an MAOI, please consult your doctor or pharmacist for guidance.

Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health is a priority, and your provider can help you navigate any concerns.

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 with clean hands and in a clean environment to maintain its integrity and safety. Always follow these guidelines to ensure you are using the product correctly and safely.

Additional Information

You should take this medication orally, with adults and children aged 12 and over advised to take 20 mL every 4 hours. It's important not to exceed 6 doses in a 24-hour period. Always use the dosing cup provided to measure your dose, and keep it with the product for convenience.

If you are pregnant or breastfeeding, consult a healthcare professional before using this medication. Make sure to keep it out of reach of children. In case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is CVS Max Strength Dextromethorphan HBr, Guaifenesin used for?

It temporarily relieves cough due to minor throat and bronchial irritation, as may occur with a cold, and helps loosen phlegm (mucus) and thin bronchial secretions.

Who can use this product?

This product is intended for adults and children aged 12 years and over. It should not be used in children under 12 years of age.

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

The recommended dosage is 20 mL every 4 hours, with a maximum of 6 doses in any 24-hour period.

Are there any contraindications for this medication?

Do not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if my cough persists?

Stop use and ask a doctor if your cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

What should I do in case of overdose?

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

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

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

How should I store this medication?

Store at room temperature and do not refrigerate.

Packaging Info

Below are the non-prescription pack sizes of Cvs (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cvs.
Details

Drug Information (PDF)

This file contains official product information for Cvs, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Dextromethorphan HBr serves as a cough suppressant, while guaifenesin functions as an expectorant. The formulation includes a natural raspberry flavor to enhance palatability. This product is intended for use by individuals aged 12 years and older and is available in a dosage form of 4 fluid ounces (118 mL).

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

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

Dosage and Administration

Adults and children aged 12 years and over 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. The dosing should be measured exclusively with the dosing cup provided, which should be kept with the product to ensure accurate measurement.

This product is not intended for use in children under 12 years of age; therefore, it is contraindicated for this population.

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.

Warnings and Precautions

In the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222. Prompt action is essential to ensure patient safety.

This product is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

Patients should discontinue use and consult a healthcare provider if a cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation and management.

Side Effects

Patients should be aware that a persistent cough may indicate a serious underlying condition. It is advised that individuals discontinue use and consult a healthcare professional if the cough lasts for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These signs warrant immediate medical attention to rule out any serious health issues.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric disorders, emotional conditions, or Parkinson’s disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI. It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Cvs (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cvs.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this product. For patients aged 12 years and older, the recommended dosage is 20 mL every 4 hours. The formulation is specifically designed for adult use and is not intended for children under 12 years.

Geriatric Use

Elderly patients may be prescribed this product at the standard adult dosage of 20 mL every 4 hours, with a maximum of 6 doses in any 24-hour period. However, no specific geriatric use information is provided in the prescribing information.

Healthcare providers should exercise caution when administering this product to geriatric patients, as individual responses may vary. It is advisable to monitor for any adverse effects or changes in efficacy, particularly in those aged 65 and older, due to potential differences in pharmacokinetics and pharmacodynamics in this population.

Additionally, the product is not intended for use in children under 12 years of age, and this should be considered when evaluating treatment options for elderly patients who may have comorbidities or polypharmacy concerns.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels. Additionally, it is recommended to perform renal function tests prior to initiating therapy and periodically thereafter in patients with renal impairment to ensure safe and effective treatment.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating dosage adjustments to ensure safety and efficacy. It is essential to monitor liver function tests in this population to assess the degree of impairment and guide treatment decisions. Special precautions should be taken when administering the drug to patients with liver problems, as their compromised liver function may influence the drug's pharmacokinetics and overall therapeutic response.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose scenario.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be informed that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, patients should be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than seven days, returns, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a more serious underlying condition.

Furthermore, patients should be advised to consult a doctor before using this product if they have a cough that produces excessive phlegm (mucus) or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

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 subjected to refrigeration. Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

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. Patients should not exceed 6 doses within a 24-hour period and are advised to use the dosing cup provided, which should be kept with the product.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important 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 at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Cvs, 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, 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.