Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Guaifenesin

Last content change checked dailysee data sync status

Active ingredient
Guaifenesin 600 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
October 9, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Guaifenesin 600 mg
Other brand names
Drug class
Expectorant
Dosage form
Tablet
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 2025
Label revision date
October 9, 2025
Manufacturer
Gil Pharmaceutical Corp
Registration number
M012
NDC root
58552-338
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 medication that contains guaifenesin (600 mg), which is designed to help you manage coughs associated with colds or respiratory conditions. It works by loosening phlegm (mucus) and thinning bronchial secretions, making it easier for you to clear mucus from your airways. This can help make your cough more productive, allowing you to breathe more comfortably.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. By doing so, it aids in clearing out bothersome mucus from your bronchial passageways, making your cough more productive. This can be particularly helpful if you're dealing with respiratory issues that involve excessive 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 taking this medication, it's important to swallow the tablet whole—do not crush, chew, or break it. Make sure to take it with a full glass of water, which helps the tablet dissolve properly. You can take this medication at any time, regardless of your meal schedule.

For adults and children aged 12 and older, the recommended dose is 1 or 2 tablets every 12 hours. However, be careful not to exceed 4 tablets in a 24-hour period. If you have children under 12, this medication is not suitable for them, so please avoid using it for that age group.

What to Avoid

It's important to be cautious when using this medication. You should not take it if your cough lasts more than 7 days, returns after improvement, or is accompanied by symptoms like fever, rash, or a persistent headache. These could indicate a more serious health issue that requires medical attention. Always prioritize your health and consult a healthcare professional if you have any concerns.

Side Effects

If you are considering using this medication, please be aware that it is not recommended for children under 12 years old. You should stop using it and consult a doctor if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious condition.

Before using this medication, it's important to talk to your doctor if you have a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if your cough produces excessive mucus.

Warnings and Precautions

It’s important to be aware of some key warnings and precautions when using this medication. First, do not give this medication to children under 12 years old, as it is not safe for them.

If you accidentally take too much, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. Additionally, if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, stop taking the medication and call your doctor, as these symptoms could indicate a more serious condition.

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 potential risks associated with taking more than the recommended dose. If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, you should seek immediate medical attention. Contact your healthcare provider or go to the nearest emergency room. It’s crucial to act quickly, as timely intervention can make a significant difference in your health outcomes. Always follow the prescribed dosage and consult your doctor if you have any questions or concerns about your medication.

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

It is important to note that this medication should not be used in children under 12 years of age. If you are a parent or caregiver, please ensure that your child meets this age requirement before considering this treatment. Always consult with a healthcare professional if you have any questions or concerns about the appropriate use of this medication for your child.

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 for personalized advice. 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, especially if you have concerns about your kidney health. They can provide guidance based on your individual situation.

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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the carton is sealed properly before use. If the carton is open or the printed seal on the bottle is broken or missing, do not use the product.

For storage, keep the product in a cool, dry place at a temperature between 20°-25°C (68°-77°F). It's also important to save the carton, as it contains complete drug facts that you may need for reference. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is GILTUSS EX EXPECTORANT?

GILTUSS EX EXPECTORANT is a medication that contains Guaifenesin 600 mg as its active ingredient, designed to help loosen phlegm and make coughs more productive.

How should I take GILTUSS EX EXPECTORANT?

You should take 1 or 2 tablets every 12 hours with a full glass of water, but do not exceed 4 tablets in 24 hours. Do not crush, chew, or break the tablet.

Who should not use GILTUSS EX EXPECTORANT?

Do not use this medication if you are under 12 years of age or if your cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.

Are there any warnings associated with GILTUSS EX EXPECTORANT?

Yes, do not use for children under 12 years, and seek medical help if you experience an accidental overdose or if your cough persists with serious symptoms.

Can I use GILTUSS EX EXPECTORANT if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using GILTUSS EX EXPECTORANT.

What should I do if I experience an overdose?

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

What are the storage instructions for GILTUSS EX EXPECTORANT?

Store GILTUSS EX EXPECTORANT between 20°-25°C (68°-77°F) and do not use if the carton is open or the seal on the bottle is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Giltuss Ex Expectorant. 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 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 cough more productive.

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

Dosage and Administration

Patients should take the tablets with a full glass of water. It is important to note that the tablets must not be crushed, chewed, or broken prior to administration. This product can be taken without regard to the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours. The maximum allowable dosage should not exceed 4 tablets within a 24-hour period.

This product is not recommended for use in children under 12 years of age.

Contraindications

Use is contraindicated in patients with a cough that 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

Use of this medication is contraindicated in children under 12 years of age. Healthcare professionals should ensure that this restriction is clearly communicated to caregivers and patients.

In the event of an accidental overdose, it is imperative to seek emergency medical assistance immediately. Healthcare providers should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 for professional guidance.

Patients should be instructed to discontinue use of the medication and consult their healthcare provider if a cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation and intervention.

Side Effects

Patients should be aware that the use of this medication is not recommended for children under 12 years of age.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional 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, patients should seek medical advice prior to using this medication if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Drug Interactions

There are currently no documented drug interactions or interactions with laboratory tests associated with this medication. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time. Healthcare professionals should continue to evaluate the patient's overall medication regimen and clinical status to ensure safe and effective use.

Packaging & NDC

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

Packaging configurations for Giltuss Ex Expectorant.
Details

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. There are no established safety or efficacy profiles for this age group, and its use is contraindicated in children younger than 12 years. Healthcare professionals are advised to consider alternative treatments for pediatric patients within this age range.

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

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial for healthcare professionals to document all findings and interventions thoroughly and to report any adverse events related to overdosage to the appropriate regulatory authorities.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, there are no details provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. In the event of an accidental overdose, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed that if their cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, they should seek medical attention, as these symptoms may indicate a serious illness.

Additionally, healthcare providers should encourage patients to consult with a doctor prior to using the medication if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also be advised to seek medical advice if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in tamper-evident packaging. Healthcare professionals should ensure that the carton is not used if it is open or if the printed seal on the bottle is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20° to 25°C (68° to 77°F). It is advisable to save the carton for complete drug facts and additional information.

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

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.