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Giltuss Ex Expectorant

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Active ingredient
Guaifenesin 400 mg/10 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 400 mg/10 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
58552-145
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

Giltuss® EX EXPECTORANT is a maximum strength, alcohol-free, sugar-free, and dye-free medication designed to help you manage chest congestion. It works by loosening and thinning phlegm (mucus) in your airways, making it easier to expel and allowing for more productive coughs. With its tutti frutti flavor, this non-drowsy formula aims to relieve discomfort caused by excess mucus in your chest and throat, helping you breathe more easily.

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. 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. For adults and children aged 12 years and older, you should take 10 mL every 4 hours. If you're giving this medication to children aged 6 to under 12 years, the dose is 5 mL every 4 hours. For younger children aged 4 to under 6 years, the appropriate dose is 2.5 mL every 4 hours.

If your child is under 4 years old, it's best to consult a doctor before administering the medication. Remember to use the enclosed dosing cup to measure the correct amount, and keep this cup for future use with the product. Also, be mindful not to exceed 6 doses within a 24-hour period to avoid any potential risks.

What to Avoid

If you are using this medication, it's important to know when to stop and seek medical advice. You should stop using it and consult your doctor if your cough lasts more than one week, keeps coming back, or is accompanied by symptoms like fever, rash, or a persistent headache. A lasting cough could indicate a more serious health issue that needs attention.

Currently, there are no specific contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. Always prioritize your health and safety by following these guidelines.

Side Effects

If you experience 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.

Before using this medication, you should also talk to your doctor if you have a cough that produces a lot of mucus or if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have a cough that produces a lot of mucus or if you have a long-lasting cough due to smoking, asthma, chronic bronchitis, or emphysema. These conditions may require special attention.

You should stop using the medication and contact your doctor if your cough lasts more than a week, comes back frequently, or is accompanied by symptoms like fever, rash, or a persistent headache. These could be signs of a more serious health issue. Always keep this medication out of reach of children, and if an overdose occurs, seek medical help or contact a Poison Control Center immediately.

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 and health. Always keep emergency contact information handy, and remember that it’s better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When giving medication to your child, 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 every 4 hours. If your child is between 4 and under 6 years old, they should receive 2.5 mL every 4 hours. For children under 4 years of age, you should consult a doctor before administering any medication.

Always remember to keep the medication out of reach of children to ensure their safety. For adults and children aged 12 years and older, the dosage is 10 mL every 4 hours. Following these guidelines will help ensure that your child receives the appropriate care.

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

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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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). It's important to keep the cap tightly closed to prevent contamination or degradation. Additionally, remember to save the carton, as it contains important information about the drug, including complete drug facts that you may need later. Following these simple steps will help you use the product safely and effectively.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult with a healthcare professional before using it. Additionally, if you experience any side effects, be sure to contact your doctor for medical advice.

FAQ

What is Giltuss® EX EXPECTORANT?

Giltuss® EX EXPECTORANT is an alcohol-free, sugar-free, and dye-free cough syrup that helps loosen phlegm and relieve chest congestion.

How does 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 adults?

Adults and children 12 years and over should take 10 mL every 4 hours, not exceeding 6 doses in 24 hours.

What should I do if my cough lasts more than a week?

Stop use and ask a doctor if your cough lasts for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.

Is Giltuss® EX EXPECTORANT safe for children?

For children 6 to under 12 years, the dosage is 5 mL every 4 hours; for children 4 to under 6 years, it's 2.5 mL every 4 hours. Consult a doctor for children under 4 years.

Can I use Giltuss® EX EXPECTORANT if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What should I do in case of an overdose?

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

What flavor does Giltuss® EX EXPECTORANT have?

It has a tutti frutti flavor.

How should I store Giltuss® EX EXPECTORANT?

Store 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 Giltuss Ex Expectorant (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Giltuss Ex Expectorant.
Details

Drug Information (PDF)

This file contains official product information for 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

Adults and children aged 12 years and older are advised to take 10 mL every 4 hours, not exceeding 6 doses within a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 5 mL every 4 hours, also adhering to the maximum of 6 doses in a 24-hour timeframe. Children aged 4 to under 6 years should receive 2.5 mL every 4 hours, with the same dosage limit. For children under 4 years of age, it is essential to consult a doctor before administration.

The enclosed dosing cup should be utilized for accurate measurement of the dosage. It is recommended to retain the dosing cup for future use with this product to ensure proper dosing.

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 one week, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Warnings and Precautions

Healthcare professionals are advised to exercise caution when recommending this product. Prior to use, it is imperative to consult a physician if the patient presents with a cough that is associated with excessive phlegm (mucus) or if the cough is persistent or chronic, particularly in individuals with a history of smoking, asthma, chronic bronchitis, or emphysema.

Patients should be instructed to discontinue use and seek medical advice if their cough persists for more than one week, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

It is essential to keep this product out of the reach of children. In the event of an overdose, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients should be advised to stop use and consult a doctor if a cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, as a persistent cough may indicate a serious underlying condition.

Additionally, it is recommended that patients seek medical advice before using this product if they have a cough that occurs with excessive phlegm (mucus) or if they experience a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Giltuss Ex Expectorant (guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Giltuss Ex Expectorant.
Details

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 5 mL every 4 hours. For those aged 4 to under 6 years, the recommended dosage is 2.5 mL every 4 hours. It is advised that children under 4 years of age consult a doctor before use. For adults and children aged 12 years and over, the dosage is 10 mL every 4 hours. Care should be taken to keep the medication out of reach of children.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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 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. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols as necessary, ensuring the safety and well-being of the patient.

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 compound in these areas.

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. 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 lasts for more than one week, recurs, or is accompanied by symptoms such as 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 encourage patients to consult with a doctor prior to use if they have a cough that produces excessive phlegm (mucus) or if they experience a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in a configuration that includes a tightly sealed cap to ensure integrity. It is essential to store the product at room temperature, specifically within the range of 15° to 30°C (59° to 86°F). Healthcare professionals are advised to retain the carton for complete drug facts and additional information. Proper handling and storage conditions are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. Additionally, patients are encouraged to contact their doctor for medical advice should they experience any side effects. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for 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 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.