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Childrens Chest Congestion 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)
Marketed in the U.S.
Since 2020
Label revision date
November 26, 2025
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
Marketed in the U.S.
Since 2020
Label revision date
November 26, 2025
Manufacturer
WALGREENS COMPANY
Registration number
M012
NDC root
0363-7504

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Drug Overview

Guaifenesin is an expectorant used to help relieve chest congestion in children aged 4 years and older. It works by loosening phlegm (mucus) and thinning bronchial secretions, making it easier to clear mucus from the airways and allowing coughs to be more productive. This alcohol-free oral solution comes in a pleasant grape flavor and is designed to break up the mucus that causes congestion, providing relief from bothersome symptoms.

Uses

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

Additionally, it works to break up the mucus that can cause congestion, allowing for better airflow and comfort. If you're dealing with a cough or congestion, this medication may provide the relief you need.

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, use only the dosing cup that comes with the medication, and avoid using it with any other products.

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, the dose should be between 2.5 mL and 5 mL every 4 hours. Please note that this medication is not recommended for children under 4 years of age. Always ensure you are measuring the dose in milliliters (mL) as specified.

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 a doctor. These symptoms could indicate a more serious condition that requires medical 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, comes back, or occurs alongside a fever, rash, or persistent headache, it's important to stop using the medication and consult a doctor, as these could indicate a serious illness.

Before using this medication, especially for children, check with a doctor if the cough is accompanied by excessive mucus or if it is a persistent cough, such as one related to asthma. In the event of an overdose, seek medical help 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, or is accompanied by a fever, rash, or a persistent headache, as these may indicate a more serious health issue. In the event of an overdose, seek medical help immediately or contact a Poison Control Center.

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 numbers handy and be aware of the signs that indicate you need urgent assistance. Your health is important, so don’t hesitate to reach out for help if you think you’ve taken too much of a medication.

Pregnancy Use

When it comes to using Children's Chest Congestion Relief (guaifenesin solution) during pregnancy, there is currently no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize your health and the health of your baby by seeking professional advice.

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 passed into breast milk or if it poses any risk 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 correct dosage based on their age. For children aged 6 to under 12 years, the recommended 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 this 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 related to asthma. 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, it’s important to consult with a healthcare provider before starting the medication. 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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider, who can offer personalized guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that the provided drug insert does not include specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established guidelines for how this medication should be used 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 important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account all the medications and tests you may be using. Always feel free to ask questions and share your complete health history to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to avoid refrigerating it, as this can affect its effectiveness. When using the product, a dosing cup is provided to help you measure the correct amount safely and accurately.

Always handle the product with clean hands to maintain safety and hygiene. Following these simple storage and handling guidelines will help you use the product effectively.

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 an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive.

What is the recommended dosage for children?

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

Are there any side effects associated with GUAIFENESIN?

You should stop use and ask a doctor if a 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?

There is no specific information regarding the safety of GUAIFENESIN during pregnancy in the provided text.

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.

Can I use GUAIFENESIN if my child has asthma?

You should ask a doctor before use if your child has a persistent or chronic cough, such as occurs with asthma.

What flavor does GUAIFENESIN come in?

GUAIFENESIN is available in a grape flavor, which is naturally and artificially flavored.

Packaging Info

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

Packaging configurations for Childrens Chest Congestion Relief.
Details

Drug Information (PDF)

This file contains official product information for Childrens Chest Congestion 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 management of conditions associated with excessive mucus production in the respiratory tract. 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, it effectively breaks up mucus that causes congestion.

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

Dosage and Administration

The maximum dosage for this medication is limited to 6 doses within a 24-hour period. It is imperative that the dosing cup provided with the medication is used exclusively for measuring doses and not for any other products.

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 required.

This medication is not recommended for use in children under 4 years of age.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue 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.

Warnings and Precautions

It is imperative that healthcare professionals exercise caution when recommending this medication, particularly in pediatric patients. Prior to administration, it is essential to consult a physician if the child presents with a cough accompanied by excessive phlegm (mucus) or if there is a history of persistent or chronic cough, such as that associated with asthma.

Patients should be advised to discontinue use and seek medical attention if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more 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 crucial to keep 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. Serious adverse reactions may necessitate immediate medical attention. Patients are advised to stop use and consult a healthcare professional if a cough persists for more than 7 days, returns after improvement, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious underlying condition.

In addition, it is important to seek medical advice before use if the patient is a child experiencing a cough that produces excessive phlegm (mucus) or has a persistent or chronic cough, such as that associated with asthma.

In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 Chest Congestion Relief (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Chest Congestion Relief.
Details

Pediatric Use

Pediatric patients aged 6 years to under 12 years may be administered 5 mL to 10 mL every 4 hours, while those aged 4 years to under 6 years should receive 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 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 may indicate a serious underlying condition.

Geriatric Use

There is no specific information available 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

There is no information available regarding the use of Children's Chest Congestion Relief (guaifenesin solution) during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

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 during the use of this product.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for 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. Regular monitoring of liver function may be warranted in these patients, 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 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 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 extracted 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 improvement, 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 that produces 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 with a dosing cup included for accurate measurement. It should be stored at room temperature, ensuring that it is not refrigerated to maintain its efficacy. Proper handling is essential to preserve the integrity 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 Chest Congestion 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 Chest Congestion 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.

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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.