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Childrens Giltuss Ex Expectorant

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Active ingredient
Guaifenesin 200 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 2020
Label revision date
September 24, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 200 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 2020
Label revision date
September 24, 2025
Manufacturer
Dextrum Laboratories Inc.
Registration number
M012
NDC root
65852-016
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 Giltuss EX is a medication designed to help relieve chest congestion in children aged 4 to 12 years. It contains guaifenesin (an expectorant), which works by liquefying and loosening phlegm and mucus, making it easier for your child to cough it up. This product is alcohol-free, sugar-free, and dye-free, and it comes in a pleasant tutti frutti flavor, making it more appealing for kids.

This non-drowsy formula is specifically tailored for children, ensuring that they can find relief from congestion without unwanted side effects. If your child is experiencing chest congestion, Children's Giltuss EX may be a helpful option to consider.

Uses

If your child is between the ages of 4 and 12 and is experiencing chest congestion, this medication can help. It acts as an expectorant, which means it helps to liquefy and loosen phlegm and mucus in the airways. This can make it easier for your child to cough up the mucus and breathe more comfortably.

Rest assured, there are no specific teratogenic effects (which refer to substances that can cause birth defects) or nonteratogenic effects noted with this medication. Always consult with a healthcare professional if you have any questions or concerns about its use.

Dosage and Administration

When using this medication, it's important to follow the correct dosage to ensure safety and effectiveness. For adults and children aged 12 years and older, you should take 10 ml every 4 hours, but remember not to exceed 6 doses in a 24-hour period. If you're giving this medication to children, use the enclosed dosing cup to measure the correct amount.

For children aged 6 to under 12 years, the dosage is 5 ml every 4 hours, while children aged 4 to under 6 years should receive 2.5 ml every 4 hours. If your child is under 4 years old, it's best to consult a doctor before administering this medication. Make sure to keep the dosing cup for future use with this product to ensure accurate measurements.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications listed, you should stop using the medication and consult your doctor if you experience any concerning symptoms or side effects.

Always prioritize your health and safety by following these instructions closely. If you have any questions or uncertainties about your treatment, don't hesitate to reach out to your healthcare provider for guidance.

Side Effects

It's important to be aware of potential side effects when using this medication. If you experience any unusual symptoms or reactions, you should stop using the medication and consult your doctor immediately. This is crucial for your safety and well-being.

Always keep an eye out for any severe reactions, and don't hesitate to reach out to your healthcare provider if you have concerns. Your health is the top priority, and your doctor can provide guidance tailored to your situation.

Warnings and Precautions

It's important to be aware of how to use your medication safely. If you experience any unusual symptoms or side effects, you should stop taking the medication and call your doctor for guidance.

While there are no specific warnings or precautions listed, always stay informed about your health and communicate openly with your healthcare provider. If you have any concerns or questions about your treatment, don’t hesitate to reach out for professional advice.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital right away. Having the medication packaging or details on hand can help healthcare professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Children's Giltuss Ex Expectorant (guaifenesin) during pregnancy. The product insert does not mention any risks or contraindications for pregnant individuals, nor does it specify any dosage modifications or special precautions for use during this time.

As always, it's best to consult with your healthcare provider before using any medication while pregnant to ensure it is safe 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

If your child is under 4 years old, it's important to consult a doctor before giving them this medication. For children aged 4 to under 6 years, the recommended dose is 2.5 ml every 4 hours. If your child is between 6 and 12 years old, they can take 5 ml every 4 hours.

Regardless of your child's age, make sure not to exceed 6 doses in a 24-hour period. Always follow these guidelines to ensure your child's safety and well-being.

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 a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

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 related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, ideally between 15-30 °C (59° - 86 °F). Make sure to close the cap tightly after each use to prevent contamination. It's also important to keep the original carton, as it contains complete drug facts that you may need for reference.

By following these simple storage and handling guidelines, you can help maintain the effectiveness of the product while ensuring your safety.

Additional Information

No further information is available.

FAQ

What is Children's Giltuss EX?

Children's Giltuss EX is an expectorant that helps liquefy and loosen phlegm and mucus associated with chest congestion. It is alcohol-free, sugar-free, dye-free, and has a tutti frutti flavor.

What is the recommended dosage for children?

For children aged 4 to under 6 years, the dosage is 2.5 ml every 4 hours. For children aged 6 to under 12 years, it is 5 ml every 4 hours. Adults and children 12 years and over should take 10 ml every 4 hours.

Are there any age restrictions for using Children's Giltuss EX?

Children's Giltuss EX is indicated for children aged 4 to 12 years. For children under 4 years, you should consult a doctor.

How should I measure the dosage?

Use the enclosed dosing cup to measure the dosage accurately. Keep the dosing cup for use with this product.

What should I do if I experience side effects?

If you experience any side effects, stop use and ask a doctor.

Is there any information about using Children's Giltuss EX during pregnancy?

There is no specific information provided regarding the use of Children's Giltuss EX during pregnancy.

Can I take more than the recommended dosage?

No, do not take more than 6 doses in any 24-hour period.

What is the storage requirement for Children's Giltuss EX?

Store Children's Giltuss EX at room temperature between 15-30 °C (59° - 86 °F) and close the cap tightly.

Packaging Info

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

Packaging configurations for Childrens Giltuss Ex Expectorant.
Details

Drug Information (PDF)

This file contains official product information for Childrens Giltuss Ex Expectorant, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated as an expectorant for children aged 4 to 12 years. It aids in liquefying and loosening phlegm and mucus associated with chest congestion, facilitating easier breathing and improved respiratory function.

Limitations of Use: There are no specific teratogenic or nonteratogenic effects associated with this drug. However, healthcare professionals should exercise caution and consider individual patient circumstances when prescribing this medication.

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. The enclosed dosing cup should be utilized for accurate measurement, and it is advised to retain the dosing cup for future use with this product.

For pediatric patients, the following dosing guidelines apply:

  • Children under 4 years of age: Consultation with a healthcare professional is required prior to administration.

  • Children aged 4 to under 6 years: Administer 2.5 ml every 4 hours as needed.

  • Children aged 6 to under 12 years: Administer 5 ml every 4 hours as needed.

For adults and children aged 12 years and older, the recommended dosage is 10 ml every 4 hours as needed.

Contraindications

There are no specific contraindications identified for this product. However, it is advised that patients discontinue use and consult a healthcare professional if any adverse effects occur or if there are concerns regarding its use.

Warnings and Precautions

Healthcare professionals should be aware of the following considerations regarding the safe use of this medication.

In the event of adverse reactions or unexpected symptoms, it is imperative to stop use immediately and consult a healthcare provider. This precaution is essential to ensure patient safety and to address any potential complications that may arise during treatment.

Currently, there are no specific warnings, general precautions, or laboratory tests associated with this medication. However, healthcare professionals are encouraged to remain vigilant and monitor patients for any changes in their condition that may necessitate further evaluation or intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. In the event of serious adverse reactions, it is advised to stop use and consult a healthcare professional immediately.

Participants in clinical trials and postmarketing experiences have indicated that certain adverse reactions may occur. It is crucial for patients to monitor their health and report any unusual symptoms to their healthcare provider.

For any concerns regarding the safety and efficacy of the medication, patients are encouraged to seek medical advice promptly.

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 necessary at this time.

Packaging & NDC

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

Packaging configurations for Childrens Giltuss Ex Expectorant.
Details

Pediatric Use

Pediatric patients under 4 years of age should consult a doctor before use. For children aged 4 to under 6 years, the recommended dosage is 2.5 ml every 4 hours, while children aged 6 to under 12 years should receive 5 ml every 4 hours. It is important to note that no more than 6 doses should be administered within a 24-hour period.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of Children's Giltuss Ex Expectorant (guaifenesin) during pregnancy. The prescribing information does not indicate any contraindications or risks associated with the use of this product in pregnant individuals. Additionally, no dosage modifications for pregnant individuals are specified. The insert also does not provide any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or a medical toxicologist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected overdose.

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 keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a configuration that requires careful storage and handling to maintain its integrity. It should be stored at room temperature, specifically within the range of 15-30 °C (59° - 86 °F).

To ensure optimal preservation, the cap must be closed tightly after each use. Additionally, it is important to save the carton for complete drug facts, which may be necessary for reference and compliance.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens Giltuss Ex Expectorant, 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 Giltuss Ex Expectorant, 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.