Symptom checker
Select audience type

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

ADD CONDITION

items per page

Mucus Congestion and Cough Relief

Last content change checked dailysee data sync status

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
Liquid
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
May 8, 2024
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
Liquid
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
May 8, 2024
Manufacturer
Walgreens
Registration number
M012
NDC root
0363-0512
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

Children's Mucus Congestion & Cough Relief is a medication designed for children aged 4 to 11 years to help alleviate symptoms associated with colds. 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 relieves stuffy noses.

This product works by temporarily relieving cough due to minor throat and bronchial irritation, reducing the intensity of coughing, and helping your child sleep better by suppressing the impulse to cough. Additionally, it helps clear nasal congestion and provides relief from chest congestion, making it easier for your child to breathe.

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 reduce the intensity of coughing and the urge to cough, making it easier for your child to sleep. Additionally, it can relieve nasal congestion and a stuffy nose associated with colds.

Dosage and Administration

When using this medication, it's important to follow the dosing instructions carefully to ensure safety and effectiveness. You should not take more than 6 doses within a 24-hour period. Always use the dosing cup that comes with the product, as it is specifically designed for accurate measurement. Avoid using any other dosing devices to prevent errors.

For children, the dosage varies by age. If your child is between 6 years and under 12 years, they should take 10 mL every 4 hours. For children aged 4 years to under 6 years, the dose is 5 mL every 4 hours. However, if your child is under 4 years old, this medication should not be used. Always keep the dosing cup with the product to ensure you have it on hand for each dose. If you have any questions or concerns, consult your doctor for guidance.

What to Avoid

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

Always follow the dosing instructions carefully and do not exceed the recommended amount. Misuse or taking more than directed can lead to serious health issues, including dependence (a condition where the body becomes reliant on a substance). Your child's safety is the top priority, so please adhere to these guidelines.

Side Effects

If your child experiences nervousness, dizziness, or sleeplessness, it's important to stop using the medication and consult a doctor. Additionally, if symptoms do not improve within 7 days, or if a cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, these could indicate a more serious condition that requires medical attention.

Before using this medication, consult a doctor if your child has any of the following: heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive mucus, or a chronic cough, such as one associated with asthma. Also, do not use this medication in children who are taking certain prescription drugs called monoamine oxidase inhibitors (MAOIs) or within 2 weeks of stopping them, as this can lead to serious interactions. If you're unsure about your child's medications, please ask a doctor or pharmacist.

Warnings and Precautions

It's important to be cautious when using this medication for your child. Do not give it to a child who is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, or for two weeks after stopping an MAOI. If you're unsure whether your child's prescription includes an MAOI, please consult a doctor or pharmacist.

Before using this medication, talk to your doctor if your child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or a cough that produces a lot of mucus. You should also seek medical help immediately if you suspect an overdose by contacting a Poison Control Center at 1-800-222-1222.

If your child experiences nervousness, dizziness, or sleeplessness, or if their symptoms do not improve within seven days, stop using the medication and call your doctor. Additionally, if a cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, these could be signs of a more serious issue that requires medical attention.

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 planning to become pregnant, it’s important to know that the safety of this product during pregnancy has not been established. You should consult your doctor before using it, as there may be potential risks to your fetus that are not clearly defined.

There are no specific dosage modifications provided for pregnant individuals, so it’s best to seek guidance from a healthcare professional regarding its use. Always prioritize your health and the health of your baby by discussing any medications with your doctor.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare professional before using this product. There is a possibility that it may pass into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's best to exercise caution.

Pediatric Use

You should not use this medication for children under 4 years old. For children aged 4 to under 6 years, the recommended dose is 5 mL every 4 hours, while children aged 6 to under 12 years can take 10 mL every 4 hours.

It's important to be cautious: do not give this medication to a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks. Always consult a doctor before use if your child has any heart issues, high blood pressure, thyroid problems, diabetes, or a cough with excessive phlegm. If your child experiences nervousness, dizziness, or sleeplessness, or if their symptoms do not improve within 7 days, seek medical advice. Additionally, if a cough lasts more than 7 days or is accompanied by fever, rash, or a persistent headache, contact a healthcare professional.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available in the drug insert. This means that healthcare providers may not have detailed guidelines tailored for elderly patients. If you or a loved one is an older adult considering this medication, it’s important to discuss any concerns with your doctor. 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 age-related health considerations, as older adults may have different responses to medications. Your doctor can provide personalized advice to ensure safety and effectiveness.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to be cautious when it comes to medications, especially for children. If your child is taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain psychiatric conditions, they should not use this product. Additionally, they should wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your child's prescription includes an MAOI, it's best to consult with a doctor or pharmacist to ensure their safety. Always discuss any medications or treatments with a healthcare provider to avoid potential interactions and ensure the best care for your child.

Storage and Handling

To ensure the product remains effective and safe for use, store it at room temperature, specifically between 20-25ºC (68-77ºF). Avoid refrigerating the product, as this can affect its quality. Always keep the dosing cup with the product for accurate measurement.

It's important to check the safety seal around the bottle and under the cap before use; do not use the product if this seal is broken or missing. Additionally, keep the product out of reach of children and remember to discard it after opening to maintain safety.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is Children's Mucus Congestion & Cough Relief used for?

It helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and temporarily relieving cough, nasal congestion, and stuffy nose.

What are the active ingredients in this product?

The active ingredients are Dextromethorphan HBr (5 mg), Guaifenesin (100 mg), and Phenylephrine HCl (2.5 mg).

What is the recommended dosage for children?

For children 6 years to under 12 years, the dosage is 10 mL every 4 hours. For children 4 years to under 6 years, it is 5 mL every 4 hours. Do not use in children under 4 years.

Are there any contraindications for using this product?

Do not use in children taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor if unsure.

What should I do if my child experiences side effects?

Stop use and ask a doctor if your child becomes nervous, dizzy, or sleepless, or if symptoms do not improve within 7 days.

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established, so consult a doctor before use.

Can nursing mothers use this product?

Nursing mothers should consult a healthcare professional before using this product, as it may be excreted in breast milk.

How should this product be stored?

Store between 20-25ºC (68-77ºF), do not refrigerate, and keep out of reach of children.

Packaging Info

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

Packaging configurations for Mucus Congestion and Cough Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Dextromethorphan hydrobromide (HBr) 5 mg serves as a cough suppressant, while guaifenesin 100 mg functions as an expectorant. Phenylephrine hydrochloride (HCl) 2.5 mg acts as a nasal decongestant. This formulation is alcohol-free and is designed to provide relief from chest congestion, cough, and nasal stuffiness by breaking up mucus. It is intended for use in children aged 4 to 11 years and is available in a berry flavor. A dosage cup is provided for accurate administration.

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 the impulse to cough, which may help children achieve restful sleep. It also alleviates nasal congestion and a stuffy nose associated with colds.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. It is imperative to utilize only the enclosed dosing cup specifically designed for this product; the use of any other dosing device is not advised. The dosing cup should be kept with the product at all times.

Dosing recommendations are as follows, unless otherwise directed by a healthcare professional:

  • For children aged 6 years to under 12 years, the dosage is 10 mL every 4 hours.

  • For children aged 4 years to under 6 years, the dosage is 5 mL every 4 hours.

  • The product is not recommended for use in children under 4 years of age.

Contraindications

Use of this product is contraindicated in children who 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 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a child's prescription medication, consultation with a healthcare professional is advised prior to use.

Furthermore, this product should not be used in excess of the directed dosage.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions when considering the use of this product in pediatric patients.

Warnings This product must not be administered to children who are 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 a period of two weeks following the cessation of an MAOI. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is essential to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

General Precautions Before administering this product, it is advisable to consult a healthcare provider if the child has any of the following conditions:

  • Heart disease

  • High blood pressure

  • Thyroid disease

  • Diabetes

  • A cough that produces excessive phlegm (mucus)

  • A persistent or chronic cough, such as that associated with asthma

Emergency Medical Help Instructions In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Stop Taking and Call Your Doctor Instructions Parents or guardians should discontinue use and consult a healthcare provider if the child experiences any of the following:

  • Nervousness, dizziness, or sleeplessness

  • Symptoms that do not improve within seven days or are accompanied by fever

  • A cough that persists for more than seven days, recurs, or is associated with fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition.

Side Effects

Patients should be monitored for adverse reactions when using this product. Serious adverse reactions may necessitate discontinuation of use and consultation with a healthcare professional. Parents are advised to seek medical attention if their child experiences symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a headache that lasts, these may indicate a serious underlying condition.

Before administering this product, it is important to consult a healthcare provider if the child has a history of heart disease, high blood pressure, thyroid disease, diabetes, or a cough associated with excessive phlegm. Caution is also advised for children with persistent or chronic coughs, such as those associated with asthma.

This product should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping such medication. Parents should verify with a healthcare professional or pharmacist if they are uncertain whether their child's prescription includes an MAOI.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated in pediatric patients. MAOIs are typically prescribed for the treatment of depression, certain psychiatric or emotional conditions, and Parkinson's disease. It is essential to avoid administering this product to a child who is currently taking an MAOI or has discontinued an MAOI within the past two weeks.

Healthcare providers should ensure that patients or caregivers are informed about the presence of MAOIs in any prescription medications. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is advisable to consult a healthcare professional, such as a doctor or pharmacist, prior to the use of this product.

Packaging & NDC

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

Packaging configurations for Mucus Congestion and Cough Relief.
Details

Pediatric Use

Pediatric patients under 4 years of age should not use this medication. For children aged 4 years to under 6 years, the recommended dosage is 5 mL every 4 hours. In children aged 6 years to under 12 years, the dosage increases to 10 mL every 4 hours.

Caution is advised when administering this medication. It should not be used in children who are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after discontinuing an MAOI. Prior to use, healthcare professionals should be consulted if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a cough that produces excessive phlegm, or a persistent or chronic cough, such as that associated with asthma.

Parents or caregivers should stop use and consult a doctor if the child experiences nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they occur with fever, or if a cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, medical advice should be sought.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the general considerations for pharmacotherapy in this population. Additionally, clinicians should consider individual patient factors, including comorbidities and concurrent medications, when determining the appropriateness of this treatment for geriatric patients.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. While potential risks to the fetus are not clearly defined, caution is advised when considering the use of this product in this population. There are no specific dosage modifications for pregnant individuals; therefore, it is essential to seek guidance from a healthcare professional regarding appropriate use.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk. The effects on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 the use of 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 available 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 at 1-800-222-1222 for guidance on managing the situation effectively.

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 to address any complications that may arise during the course of treatment.

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

No postmarketing experience details are available in the provided data.

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. 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 there is uncertainty regarding whether a child's prescription includes an MAOI, patients should be encouraged to consult with a doctor or pharmacist prior to using this product.

Patients should be instructed to discontinue use and consult a doctor if the child experiences nervousness, dizziness, or sleeplessness. Additionally, they should be made aware that if symptoms do not improve within seven days or are accompanied by fever, they should seek medical advice. It is important to inform patients that a cough lasting more than seven days, recurring, or associated with fever, rash, or a persistent headache may indicate a serious condition, warranting medical evaluation.

While using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should also encourage patients to consult a doctor before use if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a cough that produces excessive phlegm, or a persistent or chronic cough, such as that associated with asthma.

Storage and Handling

The product is supplied in a container that includes a dosing cup. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) and to avoid refrigeration. The product features a tamper-evident seal; therefore, it should not be used if the printed safety seal around the bottle or under the cap is broken or missing. Additionally, it is crucial to keep the product out of reach of children and to discard any remaining product after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Mucus Congestion and Cough Relief, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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.