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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
September 22, 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
September 22, 2025
Manufacturer
Dextrum Laboratories Inc.
Registration number
M012
NDC root
65852-008
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 medication designed to help relieve chest congestion caused by phlegm and mucus. It contains 400 mg of guaifenesin (a medication that helps loosen mucus in the airways), making it easier for you to cough up and clear your airways. This product is alcohol-free, sugar-free, and dye-free, and it comes in a pleasant tutti frutti flavor.

This expectorant is suitable for adults and children aged 12 years and older, providing non-drowsy relief from congestion. If you're dealing with a cough due to mucus buildup, Giltuss EX Expectorant may be a helpful option to consider.

Uses

If you're dealing with chest congestion, this medication can help relieve the buildup of phlegm and mucus in your airways. By addressing these symptoms, it can make breathing easier and more comfortable for you.

Rest assured, this medication does not have any known teratogenic effects, meaning it won't cause harm to a developing fetus if you're pregnant. It's designed to help you feel better without adding unnecessary risks.

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 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 this medication. To measure the correct amount, always use the enclosed dosing cup, and keep it for future use with this product. Following these guidelines will help you use the medication safely and effectively.

What to Avoid

It's important to be aware of certain guidelines when using this medication. You should stop using it and consult your doctor if your cough lasts more than one week, comes back frequently, 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 noted risks of abuse, misuse, or dependence associated with this medication. However, always prioritize your health and seek medical advice if you have any concerns.

Side Effects

If you have a cough that produces a lot of mucus, or if you have a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema, it's important to consult your doctor before using this medication.

You should stop using the medication and seek medical advice if your cough lasts more than a 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.

Warnings and Precautions

Before using this medication, it's important to consult your doctor if you have a cough that produces a lot of phlegm (mucus) or if you have a persistent 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 one week, comes back frequently, or is accompanied by symptoms like fever, rash, or a persistent headache. A long-lasting cough could indicate a more serious health issue.

If you accidentally take too much of this medication, seek emergency medical help right away or contact a Poison Control center. Your safety is the top priority, so don’t hesitate to get assistance if needed.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect an overdose, it is important to be aware of potential signs, which may include unusual drowsiness, confusion, or difficulty breathing.

If you or someone else may have taken too much of the medication, seek immediate medical help or contact your local poison control center. It’s always better to be cautious and get professional advice in such situations.

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 keep this medication out of reach of children to prevent accidental ingestion.

In the event of an accidental overdose, seek medical assistance or contact a Poison Control center right away. Your health and safety, as well as that of your child, are paramount, so don’t hesitate to reach out for help if needed.

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 children, it's important to follow specific guidelines based on their age. For children aged 6 to under 12 years, the recommended dose is 5 ml every 4 hours. For those aged 4 to under 6 years, the dose is 2.5 ml every 4 hours. If your child is under 4 years old, you should consult a doctor before administering any medication.

Always keep medications out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, seek medical help or contact a Poison Control center right away. Your child's safety is the top priority, so following these guidelines is essential.

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 issues, 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 for the medication do not change based on renal impairment. However, it’s always best to consult with your healthcare provider about your kidney health and any medications you are taking. They can provide personalized advice and ensure that your treatment is safe and effective for you.

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 tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns 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 feel free to ask questions and share your complete list of medications and any tests you might 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 original carton, as it contains important information about the product, including complete drug 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

No further information is available.

FAQ

What is Giltuss EX Expectorant used for?

Giltuss EX Expectorant is indicated for chest congestion, phlegm, and mucus.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 10 ml every 4 hours.

What should children under 4 years of age do?

Children under 4 years of age should consult a doctor before use.

Are there any teratogenic effects associated with Giltuss EX Expectorant?

No teratogenic effects are mentioned for Giltuss EX Expectorant.

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 pregnant or breastfeeding women?

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

What flavor does Giltuss EX Expectorant come in?

Giltuss EX Expectorant comes in a Tutti Frutti flavor.

How should I store Giltuss EX Expectorant?

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

What should I do in case of accidental overdose?

In case of accidental overdose, get medical or professional help or contact a Poison Control center immediately.

Can I take more than 6 doses in a 24-hour period?

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

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 relief of chest congestion associated with phlegm and mucus.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects reported.

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 not to exceed 6 doses in a 24-hour timeframe. For children aged 4 to under 6 years, the dosage is 2.5 mL every 4 hours, with the same maximum limit of 6 doses per day.

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, and it is recommended to retain the dosing cup for future use with this product.

Contraindications

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

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they experience a cough accompanied by excessive phlegm (mucus), or if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

If a cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, patients are advised to discontinue use and seek medical advice. A persistent cough may indicate an underlying serious condition that requires further evaluation.

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control center. Prompt action is essential to ensure patient safety and appropriate management of the situation.

Side Effects

Patients should be advised to consult a healthcare professional prior to use if they experience a cough that is associated with excessive phlegm (mucus), or if they have a persistent or chronic cough, such as that which may occur with smoking, asthma, chronic bronchitis, or emphysema.

In the event that a cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, patients are instructed to discontinue use and seek medical advice. A persistent cough may indicate an underlying serious condition that requires further evaluation.

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, while those aged 4 to under 6 years should receive 2.5 ml every 4 hours. For children under 4 years of age, it is advised to consult a doctor prior to administration.

It is essential to keep the medication out of reach of children. In the event of an accidental overdose, immediate medical assistance or contact with a Poison Control center is recommended.

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

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. It is essential to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation.

In the event of an accidental overdose, immediate medical attention should be sought, or contact with a Poison Control center is advised. Additionally, this medication should be kept out of reach of children to prevent unintentional exposure.

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 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.

Healthcare providers should be aware that symptoms of overdosage may vary depending on the individual and the circumstances surrounding the event. In cases of suspected overdose, it is recommended that immediate medical attention be sought.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare professionals should monitor the patient closely for any adverse effects and provide appropriate interventions as necessary.

In the event of an overdose, contacting a poison control center or seeking guidance from a medical toxicologist may be beneficial for tailored management strategies.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to be aware of the signs and symptoms that may indicate an 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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Reports of side effects have been received through voluntary submissions and surveillance programs. Patients are advised to contact their healthcare provider for medical advice regarding any adverse events experienced.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with overdose. In the event of an accidental overdose, patients should be instructed to seek medical assistance or contact a Poison Control center immediately. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

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 15-30 °C (59° - 86 °F).

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

Additional Clinical Information

No further data are available.

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

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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.