Symptom checker
Select audience type

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

ADD CONDITION

items per page

Mucus Relief Cough

Last content change checked dailysee data sync status

Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2022
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
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2022
Label revision date
May 8, 2024
Manufacturer
Walgreens
Registration number
M012
NDC root
0363-5527
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 Cough is a medication designed for children aged 4 to 11 years, formulated to provide temporary relief from coughs caused by minor throat and bronchial irritation, such as those associated with the common cold or inhaled irritants. It contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant, and guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions. This combination works to break up mucus that causes congestion while also controlling the impulse to cough, making it easier for your child to rest.

This alcohol-free syrup has a pleasant cherry flavor and comes with a dosage cup for easy administration. By helping to clear the bronchial passageways of bothersome mucus, Children's Cough aims to make coughs more productive and reduce the intensity of coughing, allowing your child to sleep more comfortably.

Uses

If you're dealing with a cough caused by minor throat and bronchial irritation, such as from a common cold or inhaled irritants, this medication can help. It works by loosening phlegm (mucus) and thinning bronchial secretions, making it easier for you to clear out bothersome mucus and have more productive coughs.

Additionally, it temporarily relieves the intensity of your cough and can help reduce the urge to cough, which may be especially helpful for your child at bedtime. This way, you can both find some relief and get a better night's sleep.

Dosage and Administration

When using this medication, it's important to follow the dosing instructions carefully to ensure safety and effectiveness. First, make sure to shake the bottle well before each use. You should only measure the dose using the dosing cup that comes with the product; avoid using any other measuring devices to ensure accuracy.

For children aged 6 to 12 years, the recommended dose is between 5 to 10 milliliters (mL) every 4 hours. If your child is between 4 and 5 years old, they should receive 2.5 to 5 mL every 4 hours. However, if your child is under 4 years old, this medication should not be used. Remember, you should not take more than 6 doses in a 24-hour period, so keep track of how many doses have been given. Always keep the dosing cup with the product for easy access.

What to Avoid

You should avoid using this product if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications often prescribed for depression, certain psychiatric or emotional 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 child's medication includes an MAOI, it's important to consult with a doctor or pharmacist before proceeding.

Taking this precaution is crucial to prevent potential serious interactions and ensure your child's safety. Always prioritize open communication with healthcare professionals regarding any medications your child is using.

Side Effects

You should be aware of some important side effects and warnings associated with this medication. It is not safe to use if your child is currently taking a prescription 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.

Before using this medication, consult a doctor if your child has a cough with excessive mucus or a persistent cough, such as one caused by asthma. If the cough lasts more than seven days, returns, or is accompanied by fever, rash, or a lasting headache, stop using the medication and seek medical advice, as these may indicate a more serious issue. In case of an overdose, it is crucial to get medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

It's important to be cautious when using this medication, especially for children. Do not give it to a child who is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has taken one in the past two weeks. If you're unsure whether your child's medication contains an MAOI, please consult a doctor or pharmacist.

Before using this product, check with a doctor if your child has a cough that produces a lot of mucus or a persistent cough, such as one associated with asthma. If your child's cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or headache that persists, stop using the medication and contact a doctor, as these could indicate a more serious issue.

In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your child's safety is the top priority, so don't hesitate to reach out for assistance if needed.

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. There may be potential risks to your fetus, so it is generally advised to avoid using this medication unless it is clearly necessary. Always consult your doctor before using this product to discuss any potential risks and to ensure it is safe for you and your baby.

There are no specific dosage modifications for pregnant individuals, but special precautions should be taken. Make sure to have a thorough conversation with your healthcare provider about your situation and any concerns you may have regarding the use of this medication during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with your healthcare professional before using this product. There is a possibility that the ingredients may be passed into your breast milk, which could pose risks to your infant. Therefore, exercise caution when considering this product while nursing, as it may affect both your milk production and your baby's health.

Pediatric Use

It's important to be cautious when giving medication to children. If your child is taking a prescription monoamine oxidase inhibitor (MAOI), do not use this medication, and wait at least two weeks after stopping the MAOI before considering it. Always consult a doctor if your child has a cough with excessive mucus or a persistent cough, such as one associated with asthma. If the cough lasts more than seven days, returns, or is accompanied by a fever, rash, or headache, stop using the medication and seek medical advice.

For dosing, children aged 6 to 12 years can take 5-10 mL every four hours, while those aged 4 to 5 years should take 2.5-5 mL every four 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, contact a medical professional or the Poison Control Center immediately at 1-800-222-1222.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory) that can occur with age.

Make sure to inform your doctor about any other medications being taken, as well as any health conditions, to ensure the safest and most effective treatment plan. Always prioritize open communication with your healthcare team to address any concerns you may have.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the provided information. This means that the usual recommendations for monitoring or precautions related to liver function are not detailed.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance tailored to your specific situation.

Drug Interactions

It's crucial to be aware of potential interactions when considering medications for yourself or your child. For instance, if your child is taking a prescription monoamine oxidase inhibitor (MAOI)—a type of medication often used for depression or certain emotional conditions—you should avoid using this product. This includes a two-week period after stopping the MAOI. If you're unsure whether your child's medication includes an MAOI, it's important to consult with a healthcare provider, such as a doctor or pharmacist, to ensure safety.

Always discuss any medications or treatments with your healthcare provider to prevent harmful interactions and to ensure the best care for you or your loved ones.

Storage and Handling

To ensure the best use of your product, store it at room temperature, specifically between 20-25ºC (68-77ºF). Avoid refrigerating it, as this can affect its effectiveness. Always keep the dosing cup with the product for accurate measurement. Before using, make sure to shake the bottle well to mix the contents properly.

It's important to check the packaging for safety. Do not use the product if the carton is opened or if the printed safety seal around the bottle or under the cap is broken or missing. After opening, please remember to discard any unused product to maintain safety and effectiveness.

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 Cough used for?

Children's Cough is used to temporarily relieve cough due to minor throat and bronchial irritation, which may occur with the common cold or inhaled irritants.

What are the active ingredients in Children's Cough?

The active ingredients are Dextromethorphan HBr (5 mg), a cough suppressant, and Guaifenesin (100 mg), an expectorant that helps loosen phlegm.

What is the recommended dosage for children aged 6 to 12 years?

Children aged 6 to 12 years should take 5-10 mL every 4 hours.

Can I use Children's Cough for children under 4 years old?

No, Children's Cough should not be used in children under 4 years of age.

What should I do if my child's cough lasts more than 7 days?

If your child's cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache, you should stop use and consult a doctor.

Is Children's Cough safe to use during pregnancy?

The safety of Children's Cough during pregnancy has not been established, and it is advised to consult a healthcare provider before use.

What precautions should I take if my child is taking other medications?

Do not use Children's Cough in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

How should I store Children's Cough?

Store Children's Cough between 20-25ºC (68-77ºF) and do not refrigerate. Keep the dosing cup with the product.

What should I do in case of an overdose?

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

What flavor does Children's Cough have?

Children's Cough has a cherry flavor and is alcohol-free.

Packaging Info

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

Packaging configurations for Mucus Relief Cough.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Dextromethorphan hydrobromide (HBr) is a cough suppressant, provided at a dosage of 5 mg per unit. Guaifenesin, an expectorant, is included at a dosage of 100 mg per unit. The formulation is alcohol-free and features a cherry flavoring to enhance palatability.

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 helps to loosen phlegm (mucus) and thin bronchial secretions, 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, thereby assisting children in achieving restful sleep.

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the following dosage and administration guidelines.

Before administration, the product must be shaken well. The dosing cup provided with the product should be used exclusively for measuring doses; no other dosing devices should be utilized. It is essential to keep the dosing cup with the product at all times to ensure accurate measurement.

For children aged 6 to 12 years, the recommended dosage is 5 to 10 mL every 4 hours, with a maximum of 6 doses within a 24-hour period. For children aged 4 to 5 years, the dosage is 2.5 to 5 mL every 4 hours, also not exceeding 6 doses in a 24-hour period. The product is not recommended for use in children under 4 years of age.

It is critical to monitor the total number of doses administered to prevent exceeding the maximum limit within a 24-hour timeframe.

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, this product should not be administered for a period of 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, such as a doctor or pharmacist, is advised prior to use.

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 presents with a cough accompanied by excessive phlegm (mucus) or if the cough is persistent or chronic, as seen in conditions such as asthma. These symptoms may indicate underlying health issues that require further evaluation.

Caregivers should be instructed to discontinue use and seek medical advice if the child's cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may signify a serious medical condition that necessitates prompt attention.

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. Timely intervention is critical in managing potential overdose situations effectively.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the discontinuation of such medication, as this may lead to serious interactions.

Before administering this medication to a child, it is advisable to consult a healthcare professional if the child has a cough accompanied by excessive phlegm or if the cough is persistent or chronic, such as that which occurs with asthma.

Patients should discontinue use and seek medical advice if the cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

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. Administration of this product in children who are currently taking an MAOI, or within 14 days of discontinuing an MAOI, may lead to serious adverse effects.

Healthcare professionals are advised to confirm whether a child's prescription includes an MAOI prior to initiating treatment with this product. If there is any uncertainty regarding the presence of an MAOI in the child's medication regimen, consultation with a physician or pharmacist is strongly recommended.

Packaging & NDC

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

Packaging configurations for Mucus Relief 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 discontinuing an MAOI. Prior to administration, it is advisable to consult a healthcare professional if the child has a cough accompanied by excessive phlegm or a persistent cough, such as that associated with asthma.

If a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a headache that lasts, the use of this medication should be discontinued, and a doctor should be consulted. 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.

For dosing, children aged 6 to 12 years may receive 5-10 mL every 4 hours, while those aged 4 to 5 years may receive 2.5-5 mL every 4 hours. This medication is not recommended for children under 4 years of age.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus. Use of this medication should be avoided unless clearly needed. No specific dosage modifications are provided for pregnant individuals. It is essential for women of childbearing potential to discuss the use of this medication with their healthcare provider to ensure informed decision-making regarding potential risks and benefits.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and caution is advised when administering this product to nursing mothers due to the potential risk to the infant.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

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 an 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

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.

It is crucial to inform patients that this medication should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such a medication. Patients should be encouraged to consult with a doctor or pharmacist if they are uncertain whether their child's prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a healthcare professional if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition.

Additionally, healthcare providers should recommend that patients consult a doctor prior to use if the child has a cough associated with excessive phlegm (mucus) or if the child experiences a persistent or chronic cough, such as that which occurs 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. Prior to use, the product must be shaken well.

To ensure safety and integrity, the product features a tamper-evident design; therefore, it should not be used if the carton is opened or if the printed safety seal around the bottle or under the cap is broken or missing. Additionally, the product should be discarded after opening to maintain 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 Relief 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 Mucus Relief 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

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.