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Childrens Mucus Relief

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Active ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Drug class
Expectorant
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 2015
Label revision date
December 4, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 100 mg/5 mL
Other brand names
Drug class
Expectorant
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 2015
Label revision date
December 4, 2025
Manufacturer
Chain Drug Manufacturing Assn
Registration number
M012
NDC root
63868-770
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

Guaifenesin is a children's mucus relief expectorant available as an oral solution with a pleasant grape flavor. It is designed to help loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to clear mucus from your airways and have more productive coughs. This medication is effective in relieving chest congestion and breaking up mucus, providing comfort when you're feeling congested.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it makes it easier to clear out bothersome mucus from your airways, which can lead to more productive coughs.

In addition to helping with mucus, this medication also provides relief from chest congestion, making it a useful option if you're feeling blocked up or uncomfortable in your chest. Overall, it works to break up mucus, helping you feel more comfortable and breathe more freely.

Dosage and Administration

When using this medication, it's important to follow the dosing guidelines carefully to ensure safety and effectiveness. You should never take more than 6 doses within a 24-hour period. To measure your dose accurately, always use the dosing cup that comes with the medication, and avoid using it with any other products to prevent confusion.

For children aged 6 years to under 12 years, the recommended dose is between 5 mL and 10 mL every 4 hours. If your child is between 4 years and under 6 years, they should receive 2.5 mL to 5 mL every 4 hours. However, if your child is under 4 years old, this medication is not suitable for them. Always ensure you are measuring in milliliters (mL) for precision.

What to Avoid

You should be aware of a few important guidelines regarding your health. If your cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache, it’s crucial to stop using the medication and consult your doctor. These symptoms could indicate a more serious condition that needs attention.

Currently, there are no specific contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence related to this medication. However, always prioritize your health and seek professional advice if you have any concerns.

Side Effects

If you experience a cough that lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, it's important to stop using the medication and consult a doctor, as these symptoms may indicate a serious illness.

Before using this medication, especially for children, consult a doctor if the cough is associated with excessive mucus or if it is a persistent cough, such as one related to asthma. In the event of an overdose, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if your child has a cough that produces a lot of mucus or if they have a persistent cough, such as one associated with asthma.

You should stop using the medication and call your doctor if the cough lasts more than 7 days, returns after improvement, or is accompanied by a fever, rash, or a persistent headache, as these may indicate a more serious condition.

In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately. Always keep this medication out of reach of children to ensure their safety.

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 what you would typically experience with the medication.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact information handy, and remember that it’s better to be cautious and seek help if you have any concerns about an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. It is generally not recommended for use unless specifically directed by your healthcare provider. There may be potential risks to your fetus, but these risks are not clearly defined, so it's crucial to consult with your healthcare professional for personalized advice.

Additionally, if you are prescribed this medication, be aware that dosage adjustments may be necessary. Always approach the use of this medication during pregnancy with caution and under the supervision of your healthcare provider to ensure the best outcomes for you and 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. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When giving this medication to children, it's important to follow the recommended dosages based on their age. For children aged 6 to under 12 years, the dose is 5 mL to 10 mL every 4 hours. For those aged 4 to under 6 years, the dose is 2.5 mL to 5 mL every 4 hours. However, do not use this medication for children under 4 years old.

Before using the medication, consult a doctor if your child has a cough that produces a lot of mucus or if they have a persistent cough, which could be a sign of asthma. Additionally, if your child's cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or ongoing headache, stop using the medication and seek medical advice, as these symptoms may indicate a more serious condition.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations for patients with renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how to manage your treatment effectively.

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 available information. This means that the standard recommendations apply, and there are no special monitoring or precautions outlined for patients with liver impairment.

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 based on your individual situation and any other health considerations you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best use of your product, store it at room temperature and avoid refrigerating it, as this can affect its effectiveness. When handling the product, check the tamper-evident seal under the cap; do not use it if the seal is torn or missing, as this indicates that the product may not be safe to use.

You will find a dosing cup included with the product, which is designed to help you measure the correct amount safely. Always follow these guidelines to maintain the product's integrity and your 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 Guaifenesin used for?

Guaifenesin is used to help loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and relieving chest congestion.

What is the recommended dosage for children?

For children 6 years to under 12 years, the dosage is 5 mL to 10 mL every 4 hours. For children 4 years to under 6 years, it is 2.5 mL to 5 mL every 4 hours. Do not use in children under 4 years.

Are there any warnings associated with Guaifenesin?

Yes, you should stop use and ask a doctor if the cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache, as these could indicate a serious illness.

Is Guaifenesin safe to use during pregnancy?

Safety during pregnancy has not been established, and it is not recommended unless directed by a healthcare provider.

What should I do in case of an overdose?

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

How should Guaifenesin be stored?

Store Guaifenesin at room temperature and do not refrigerate. Ensure the tamper-evident seal is intact before use.

Is Guaifenesin alcohol-free?

Yes, Guaifenesin is alcohol-free.

What flavor is Guaifenesin?

Guaifenesin is grape flavored.

Packaging Info

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

Packaging configurations for Childrens Mucus Relief.
Details

Drug Information (PDF)

This file contains official product information for Childrens Mucus Relief, 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 drug.

Uses and Indications

This drug is indicated for the relief of chest congestion by helping to loosen phlegm (mucus) and thin bronchial secretions. It facilitates the clearance of bothersome mucus from the bronchial passageways, thereby making coughs more productive.

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

Dosage and Administration

The maximum dosage for this medication is 6 doses within a 24-hour period. Healthcare professionals should instruct patients to measure the dosage using only the dosing cup provided with the product. It is important to emphasize that the dosing cup should not be used with any other products to ensure accurate measurement.

For children aged 6 years to under 12 years, the recommended dosage is 5 mL to 10 mL administered every 4 hours as needed. For children aged 4 years to under 6 years, the dosage is 2.5 mL to 5 mL every 4 hours as needed. This medication is not recommended for use in children under 4 years of age.

Contraindications

Use is contraindicated in patients who experience a cough lasting more than 7 days, a recurrent cough, or a cough accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

It is imperative that healthcare professionals advise patients to consult a physician prior to administration 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.

Should the cough persist beyond 7 days, recur, or be accompanied by fever, rash, or a persistent headache, it is crucial to discontinue use and seek medical advice. 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 without delay to ensure appropriate management.

Additionally, it is essential to emphasize the importance of keeping this medication out of reach of children to prevent accidental ingestion and potential harm.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is important to stop use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Additionally, caregivers should seek medical advice before administering this medication to children who exhibit a cough with excessive phlegm (mucus) or a persistent or chronic cough, such as that which occurs with asthma.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised to ensure the safety and well-being of the patient.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Childrens Mucus Relief.
Details

Pediatric Use

Pediatric patients aged 6 years to under 12 years may be administered 5 mL to 10 mL every 4 hours. For those aged 4 years to under 6 years, the recommended dosage is 2.5 mL to 5 mL every 4 hours. Use is not recommended for children under 4 years of age.

Healthcare professionals should advise caregivers to consult a doctor prior to use if the child has a cough accompanied by excessive phlegm (mucus) or a persistent cough, such as that associated with asthma. Additionally, caregivers should be instructed to discontinue use and seek medical advice if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious illness.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Safety during pregnancy has not been established for this medication. It is not recommended for use during pregnancy unless directed by a healthcare provider. The potential risks to the fetus are not clearly defined; therefore, healthcare professionals should be consulted for personalized advice regarding the use of this medication in pregnant patients.

Dosage adjustments may be necessary for pregnant patients, and specific recommendations should be obtained from a healthcare provider. Use during pregnancy should be approached with caution and under medical supervision to ensure the safety of both the mother and the developing 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 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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

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 specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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 provided data.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if their cough persists for more than 7 days, returns after resolution, or is accompanied by fever, rash, or a persistent headache, as 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 cough is persistent or chronic, such as that which occurs with asthma. This precaution is essential to ensure the safe and effective use of the medication.

Storage and Handling

The product is supplied in a configuration that includes a dosing cup. It is essential to store the product at room temperature and to avoid refrigeration. The packaging features a tamper-evident design; therefore, it should not be used if the printed inner seal under the cap is torn or missing. Proper handling and storage conditions are crucial to ensure the integrity and safety of the product.

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 Childrens Mucus 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 Childrens Mucus 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

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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.