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Congestion and Cough

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Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
  • Phenylephrine Hydrochloride 2.5 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
January 5, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
  • Phenylephrine Hydrochloride 2.5 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Solution
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
January 5, 2026
Manufacturer
CVS PHARMACY
Registration number
M012
NDC root
69842-756
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This product is a children's cough and congestion oral solution with a pleasant berry flavor, designed for children aged 4 to 11 years. It contains three active ingredients: dextromethorphan HBr, which acts as a cough suppressant; guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions; and phenylephrine HCl, a nasal decongestant that temporarily relieves stuffy noses and nasal congestion.

The solution works by helping to clear mucus from the bronchial passageways, making coughs more productive and easing the discomfort associated with minor throat and bronchial irritation, often caused by the common cold or inhaled irritants. It also helps reduce the urge to cough, which can assist your child in getting a better night's sleep.

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 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 also helps with a stuffy nose and nasal congestion due to a cold, reduces the intensity of coughing, and can lessen the urge to cough, making it easier for children to sleep.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure safety and effectiveness. You should never take more than the directed amount, and make sure not to exceed 6 doses within a 24-hour period. Always use the dose cup that comes with the medication for accurate measurement.

For children aged 6 to under 12 years, the recommended dose is 10 mL every 4 hours. If your child is between 4 and under 6 years old, the dose is 5 mL every 4 hours. However, if your child is under 4 years old, you should not use this medication. Always consult with a doctor if you have any questions or concerns about the appropriate dosage for your child.

What to Avoid

You should avoid using this medication in children who 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 give this medication to a child for at least two weeks after they have stopped taking an MAOI. If you are unsure whether your child's prescription includes an MAOI, please consult a doctor or pharmacist before administering this product.

It's also important to follow the recommended dosage carefully and not exceed it. Taking more than the advised amount can lead to serious health issues. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.

Side Effects

You should be aware of some potential side effects when using this medication. If you experience nervousness, dizziness, or sleeplessness, it's important to stop using the medication and consult your doctor. Additionally, if your symptoms do not improve within 7 days, or if you develop a fever, persistent cough, rash, or headache, seek medical advice, as these could indicate a more serious condition.

It's crucial not to use this medication in children who are taking certain antidepressants known as monoamine oxidase inhibitors (MAOIs) or for two weeks after stopping them. Before using this medication, consult your doctor if your child has diabetes, heart disease, thyroid disease, high blood pressure, or a chronic cough, especially if it involves excessive mucus. In case of an overdose, seek immediate medical help or contact a Poison Control Center.

Warnings and Precautions

You should not use this medication for a child who is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of prescription drug used for depression or certain other conditions, or for two weeks after stopping an MAOI. If you're unsure whether your child's medication contains an MAOI, please consult a doctor or pharmacist.

Before giving this medication to your child, it's important to check with a doctor if they have any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a persistent cough (especially if related to asthma), or a cough with excessive mucus.

If you suspect an overdose, seek emergency medical help or contact a Poison Control Center immediately. Additionally, stop using the medication and call your doctor if your child experiences nervousness, dizziness, or sleeplessness, if symptoms do not improve within seven days or are accompanied by a fever, or if a cough lasts more than a week, recurs, or is accompanied by a fever, rash, or persistent headache, as these may indicate a more serious issue.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Always err on the side of caution—if you or someone else is experiencing concerning symptoms after taking medication, don’t hesitate to reach out for professional assistance. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. It is generally not recommended for use during this time due to potential risks to your developing baby. If you have any questions or concerns about using this product while pregnant, you should consult your healthcare provider for personalized advice.

There are no specific dosage modifications for pregnant individuals, so it's crucial to seek medical guidance before using this product. Your healthcare provider can help you understand any associated risks and determine the best course of action for your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Currently, there is also no information available about whether this product is excreted in breast milk or any potential risks to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using any medication while breastfeeding. Your health and the health of your baby are important, and your provider can help you make informed decisions.

Pediatric Use

It's important to be cautious when giving medication to children. You should not use this medication if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks. Before using it, consult your doctor if your child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a persistent cough (like asthma), or a cough with excessive mucus.

For dosing, children aged 6 to under 12 years can take 10 mL every 4 hours, while those aged 4 to under 6 years should take 5 mL every 4 hours. This medication is not recommended for children under 4 years old. Always keep the medication out of reach of children, and in case of an overdose, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

As an older adult or caregiver, it's important to know that there are no specific dosage adjustments or safety concerns noted for elderly patients regarding this medication. This means that the standard dosage can generally be used without special modifications for older individuals. However, always consult with a healthcare provider to ensure that this medication is appropriate for your specific health needs and circumstances.

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 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 crucial to talk to your healthcare provider about any medications you or your child are taking. If your child is on a prescription monoamine oxidase inhibitor (MAOI), a type of medication used to treat certain mental health conditions, you should avoid using this drug. Doing so can lead to serious interactions, especially if the MAOI was taken within the last two weeks. Always ensure that your healthcare provider is aware of all medications to help prevent any harmful effects.

Storage and Handling

To ensure the best performance of your product, store it at a temperature of 25°C (77°F). It can safely be kept within a range of 15°-30°C (59°-86°F) for short periods. Always check the end flap for the expiration date and lot number to confirm the product's validity and safety.

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

Additional Information

There are no specific laboratory tests or patient counseling details available for this medication. It is important to note that this medication is taken orally.

If you are concerned about the potential for medicine abuse, especially among teens, you can find helpful resources at www.StopMedicineAbuse.org.

FAQ

What is DEXTROMETHORPHAN HBr, GUAIFENESIN, PHENYLEPHRINE HCl used for?

This medication is used to temporarily relieve cough due to minor throat and bronchial irritation, stuffy nose, and nasal congestion due to a cold.

What are the active ingredients in this cough and congestion solution?

The active ingredients are DEXTROMETHORPHAN HBr (a cough suppressant), GUAIFENESIN (an expectorant), and PHENYLEPHRINE HCl (a nasal decongestant).

What age group is this medication suitable for?

This medication is indicated for children aged 4 to 11 years.

How should I administer this medication to my child?

For children 6 to under 12 years, give 10 mL every 4 hours; for children 4 to under 6 years, give 5 mL every 4 hours. Do not use in children under 4 years.

Are there any contraindications for using this medication?

Do not use this medication in children taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

What should I do if my child experiences side effects?

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

Is it safe to use this medication during pregnancy?

Safety during pregnancy has not been established, and it is not recommended due to potential risks to the fetus.

What should I do in case of an overdose?

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

What are the storage instructions for this medication?

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

What additional precautions should I take?

Ask a doctor before use if your child has diabetes, heart disease, thyroid disease, high blood pressure, or a persistent cough.

Packaging Info

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

Packaging configurations for Congestion and Cough.
Details

Drug Information (PDF)

This file contains official product information for 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 and nasal congestion associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the expulsion of bothersome mucus and enhancing the productivity of coughs.

Additionally, this drug temporarily alleviates symptoms such as a stuffy nose and nasal congestion resulting from a cold. It also reduces the intensity of coughing and the impulse to cough, which may assist children in achieving restful sleep.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and administration guidelines. The maximum dosage should not exceed the directed amount, and no more than six doses should be administered within a 24-hour period.

The provided dose cup must be utilized for accurate measurement. The dosing recommendations are as follows:

For children aged 6 to under 12 years, the recommended dose is 10 mL every 4 hours. For children aged 4 to under 6 years, the appropriate dose is 5 mL every 4 hours. It is important to note that this product is not recommended for use in children under 4 years of age.

Healthcare professionals should ensure that caregivers are informed of these guidelines to promote safe and effective use of the medication.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. If there is uncertainty regarding the presence of an MAOI in a child's prescription, consultation with a healthcare professional is advised prior to administration of this product.

Additionally, it is contraindicated to exceed the recommended dosage.

Warnings and Precautions

The use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. Healthcare professionals should advise caregivers to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

Before administering this product, it is essential to consult a healthcare provider if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a persistent or chronic cough (such as that associated with asthma), or a cough accompanied by excessive phlegm (mucus). These conditions may necessitate special consideration or alternative treatment options.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should instruct caregivers to discontinue use and seek medical advice if the child experiences nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days, or if they are accompanied by fever, further evaluation is warranted. A cough that persists for more than one week, recurs, or is associated with fever, rash, or a persistent headache may indicate a serious underlying condition and should prompt immediate medical consultation.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough persists for more than one week, recurs, or is associated with fever, rash, or persistent headache, these may indicate a serious condition requiring medical attention.

The product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, which is commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease.

Before using this product, it is important for caregivers to consult a healthcare provider if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, persistent or chronic cough (such as that associated with asthma), or a cough that produces excessive phlegm (mucus).

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Administration in pediatric patients who are currently taking an MAOI or have discontinued an MAOI within the past two weeks may result in serious interactions. It is essential to avoid this combination to prevent potential adverse effects. Monitoring for any signs of interaction is advised if there is a possibility of exposure to MAOIs within the specified timeframe.

Packaging & NDC

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

Packaging configurations for Congestion and Cough.
Details

Pediatric Use

Pediatric patients should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Prior to administration, it is advisable to consult a healthcare professional if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, persistent or chronic cough (such as that associated with asthma), or cough accompanied by excessive phlegm.

Dosing recommendations for pediatric patients are as follows: for children aged 6 to under 12 years, the recommended dose is 10 mL every 4 hours; for children aged 4 to under 6 years, the recommended dose is 5 mL every 4 hours. This medication is not recommended for children under 4 years of age.

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 without delay.

Geriatric Use

Elderly patients may not require specific dosage adjustments when receiving this medication, as there are no safety concerns or modifications indicated for this population in the available data. However, healthcare providers should remain vigilant in monitoring the overall health status and response to treatment in geriatric patients, given the potential for altered pharmacokinetics and increased sensitivity to medications in this age group. Regular assessment and individualized care are recommended to ensure optimal therapeutic outcomes.

Pregnancy

Safety during pregnancy has not been established for this product. Use is not recommended during pregnancy due to potential risks to the fetus. There may be risks associated with the use of this product during pregnancy; therefore, it is essential for pregnant patients to consult a healthcare provider for advice.

No specific dosage modifications are provided for pregnant individuals; personalized recommendations should be sought from a healthcare provider. Pregnant women are advised to seek medical advice before using this product to ensure the safety and well-being of both the mother and the fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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.

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 or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure the best possible outcomes for affected individuals.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified reports of several adverse reactions associated with the use of the product. These include nervousness, dizziness, sleeplessness, rash, and persistent headache.

Healthcare professionals should monitor patients for these reactions. In cases where symptoms do not improve within 7 days, or if they are accompanied by fever, it is advised that a doctor be consulted. Additionally, a cough that persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache may indicate a serious condition and warrants further medical evaluation.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that this product should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. If patients are uncertain whether their child's prescription includes an MAOI, they should be encouraged to consult a doctor or pharmacist prior to administering this product.

Patients should be instructed to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by a fever, or if a cough persists for more than one week, recurs, or is associated with fever, rash, or a persistent headache, they should seek medical advice, as these may indicate a serious condition.

It is important to emphasize that patients should not exceed the recommended dosage while using this product. Furthermore, healthcare providers should recommend that patients consult a doctor before use if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a persistent or chronic cough such as that associated with asthma, or a cough that produces excessive phlegm (mucus).

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 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 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.

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.