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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
October 9, 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
October 9, 2025
Manufacturer
Gil Pharmaceutical Corp
Registration number
M012
NDC root
58552-146
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 EXPECTORANT is a medication designed specifically for children aged 4 to 12. It is alcohol-free, sugar-free, and dye-free, making it a gentle option for young ones. This expectorant helps to loosen phlegm (mucus) and thin bronchial secretions, which can relieve chest congestion and make coughs more productive.

By liquefying and removing mucus, Children's Giltuss® EX EXPECTORANT aids in clearing the bronchial passageways, helping your child breathe easier. With a pleasant tutti frutti flavor, it offers a more enjoyable experience for children when they need relief from cough and congestion.

Uses

This medication is designed to help you breathe easier by loosening phlegm (a type of mucus) and thinning bronchial secretions. By doing so, it helps clear out bothersome mucus from your bronchial passageways, making your coughs more productive. This can be particularly helpful if you're dealing with respiratory issues that involve excess mucus.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

When using this medication, it's important to follow the dosage instructions carefully to ensure safety and effectiveness. You should not take more than 6 doses within a 24-hour period. To measure your dose accurately, use the enclosed dosing cup, and keep it for future use with this product.

For children, the dosage varies by age. If your child is under 4 years old, you should 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 under 12 years, they should take 5 mL every 4 hours. For those 12 years and older, the dose increases to 10 mL every 4 hours. Always ensure you are measuring the dose correctly to avoid any potential issues.

What to Avoid

If you are considering using this medication, it's important to know when to stop. You should stop using it and consult a doctor if your child has a cough that lasts more than one week, if the cough tends to come back, or if it is accompanied by a fever, rash, or a persistent headache. These symptoms could indicate a more serious health issue that needs attention.

Always prioritize your child's health and seek medical advice if you have any concerns about their symptoms.

Side Effects

If your child experiences a cough that lasts more than a week, keeps coming back, or is accompanied by fever, rash, or a persistent headache, it's important to stop using the medication and consult a doctor, as these could be signs of a serious condition. Additionally, if your child has a cough with excessive mucus or a chronic cough related to asthma or chronic bronchitis, you should seek medical advice before using this medication.

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

Warnings and Precautions

Before using this medication for your child, it's important to consult with a doctor if they have a cough that produces a lot of mucus or if they have a persistent cough, which can be associated with conditions like asthma or chronic bronchitis.

You should stop using the medication and call your doctor if your child's cough lasts more than a week, comes back frequently, or is accompanied by symptoms like fever, rash, or a persistent headache, as these could indicate a more serious health issue. In the event 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 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

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 solution) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use while pregnant have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to explore safer alternatives if necessary. Your health and the health of your baby are the top priority, so always seek professional advice when considering any medication during pregnancy.

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 you have a child 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. For those 12 years and older, the dosage increases to 10 mL every 4 hours. Always ensure you follow these guidelines to keep your child safe and healthy.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it's important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and conditions. Always ensure that any medication is taken under the guidance of a healthcare professional, especially for older adults who may have unique health considerations.

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.

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 your condition may affect your treatment plan.

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, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 15°-30°C (59°-86°F). It's important to keep the cap tightly closed to maintain its integrity. Additionally, remember to save the carton, as it contains important information about the drug, including complete facts that you may need later.

By following these simple storage and handling guidelines, you can help ensure the product remains safe and effective for your use.

Additional Information

You will take this medication orally. It's important to be aware of what to do in case of an overdose; if that happens, seek medical help or contact a Poison Control Center immediately. Additionally, if you experience any side effects, make sure to call your doctor for advice.

FAQ

What is Children's Giltuss® EX Expectorant?

Children's Giltuss® EX Expectorant is an alcohol-free, sugar-free, dye-free, and non-drowsy medication designed to help loosen phlegm and thin bronchial secretions.

What age group is Children's Giltuss® EX Expectorant indicated for?

It is indicated for children aged 4 to 12 years.

How does Children's Giltuss® EX Expectorant work?

It helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive by clearing the bronchial passageways.

What are the dosage instructions for Children's Giltuss® EX Expectorant?

For children 4 to under 6 years, the dosage is 2.5 mL every 4 hours; for children 6 to under 12 years, it's 5 mL every 4 hours; and for children 12 years and over, it's 10 mL every 4 hours.

Are there any warnings associated with Children's Giltuss® EX Expectorant?

Yes, you should stop use and consult a doctor if the child has a cough lasting more than 1 week, or if it is accompanied by fever, rash, or persistent headache.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately.

Is there any information regarding use during pregnancy or breastfeeding?

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

How should I store Children's Giltuss® EX Expectorant?

Store it at room temperature between 15°-30°C (59°-86°F) and keep the cap tightly closed.

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 for the facilitation of mucus clearance in patients experiencing excessive bronchial secretions. It helps to loosen phlegm and thin bronchial secretions, thereby enhancing the productivity of coughs and aiding in the clearance of bothersome mucus from the bronchial passageways.

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

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. Healthcare professionals should instruct patients to utilize the enclosed dosing cup for accurate measurement and to retain the cup for future use with this product.

For pediatric patients, the following dosing guidelines apply:

  • For children under 4 years of age, consultation with a physician is advised prior to administration.

  • For children aged 4 to under 6 years, the recommended dose is 2.5 mL every 4 hours.

  • For children aged 6 to under 12 years, the recommended dose is 5 mL every 4 hours.

  • For children aged 12 years and older, the recommended dose is 10 mL every 4 hours.

It is essential to adhere to these dosing intervals and not exceed the maximum daily limit to ensure safety and efficacy.

Contraindications

Use is contraindicated in children with a cough that persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache. A persistent cough may indicate a serious underlying condition, necessitating medical evaluation.

Warnings and Precautions

Healthcare professionals should exercise caution when administering this medication to children. It is imperative to consult a physician prior to use if the child presents with a cough characterized by excessive phlegm (mucus) or if the cough is persistent or chronic, as seen in conditions such as asthma or chronic bronchitis.

In the event that a child develops a cough lasting more than one week, experiences recurrent coughing, or exhibits accompanying symptoms such as fever, rash, or persistent headache, it is crucial to discontinue use and seek medical advice. A persistent cough may indicate an underlying serious condition that requires further evaluation.

In cases of suspected overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Additionally, it is essential to keep this medication out of reach of children to prevent accidental ingestion.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, and it is crucial to stop use and consult a healthcare professional if the child experiences a cough that lasts for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache. Such symptoms may indicate a serious underlying condition that requires medical evaluation.

Before using this medication, it is advisable to consult a healthcare provider if the child has a cough that occurs with excessive phlegm (mucus) or if there is a history of persistent or chronic cough, such as that associated with asthma or chronic bronchitis.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. This precaution is essential 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 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. In children aged 6 to under 12 years, the dosage increases to 5 mL every 4 hours. For adolescents aged 12 years and over, the recommended dosage is 10 mL every 4 hours.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information available regarding the use of Children's Giltuss EX Expectorant (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 during pregnancy. Healthcare professionals should consider the lack of data when prescribing this medication to 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.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance 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 symptoms of overdose may vary depending on the specific 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. This may include monitoring vital signs, providing respiratory support, and administering specific antidotes if available and indicated. Continuous evaluation of the patient's clinical status is necessary to ensure effective management and to address any complications that may arise.

In summary, timely medical intervention and appropriate management strategies are vital in the case of an overdose to ensure patient safety and optimal 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 provided text.

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 child experiences a cough that lasts longer than one week, recurs frequently, or is accompanied by fever, rash, or a persistent headache. It is important to communicate that a persistent cough may indicate a serious underlying condition.

Additionally, healthcare providers should recommend that patients consult a doctor before using the medication if their child has a cough that produces excessive phlegm (mucus) or if the child has a persistent or chronic cough, such as that associated with asthma or chronic bronchitis.

Storage and Handling

The product is supplied in a configuration that includes an NDC number, which should be referenced for identification. It is essential to store the product at room temperature, specifically within the range of 15° to 30°C (59° to 86°F).

To ensure the integrity of the product, the cap must be closed tightly after each use. Additionally, it is recommended to retain the carton for access to complete drug facts and information. Proper handling and storage conditions are crucial for maintaining the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately. Additionally, patients are advised to consult their healthcare provider for medical advice regarding any side effects experienced during treatment.

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

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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.