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
58552-339
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 DIABETIC 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.

If you're dealing with bothersome mucus in your bronchial passageways, GILTUSS DIABETIC EX EXPECTORANT may provide relief by aiding your body's natural ability to expel mucus.

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 excess mucus.

Rest assured, there are no teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those who may be 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

You should be aware of a few important guidelines regarding your health. If your cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache, it’s crucial to stop using the medication and consult your doctor. These symptoms could indicate a more serious condition that needs attention.

While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always prioritize your health and safety by following these instructions closely.

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 persistent or chronic cough due 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 use it for children under 12 years old. If you accidentally take too much, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should also stop taking the medication and call your doctor if your cough lasts more than 7 days, comes back, or occurs alongside symptoms like fever, rash, or a persistent headache. These could indicate a more serious health issue that needs attention.

Overdose

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

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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

While there is no specific information about the use of GILTUSS DIABETIC EX in older adults, it's important to approach any new medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before starting this medication. They can help determine if it's appropriate for you or your loved one, considering any unique health needs or conditions. Always prioritize open communication with your doctor about any medications you are taking, especially if you are an older adult or caring for one.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments or monitoring related to renal impairment (kidney issues). This means that there are no detailed recommendations available for how your treatment may need to be altered based on your kidney function.

It's always best to discuss your individual situation with your healthcare provider, who can offer 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 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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 are undergoing. This way, you can receive the best possible care tailored to your needs.

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 DIABETIC EX EXPECTORANT?

GILTUSS DIABETIC EX EXPECTORANT is a medication that contains Guaifenesin 600 mg, designed to help loosen phlegm (mucus) and make coughs more productive.

How should I take GILTUSS DIABETIC EX EXPECTORANT?

You should take 1 or 2 tablets every 12 hours with a full glass of water, without crushing, chewing, or breaking the tablet. Do not exceed 4 tablets in 24 hours.

Who should not use GILTUSS DIABETIC EX EXPECTORANT?

This product should not be used by children under 12 years of age.

What should I do if my cough lasts more than 7 days?

If your cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache, stop use and ask a doctor, as these could be signs of a serious illness.

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

If you are pregnant or breastfeeding, you should ask a health professional before using this medication.

What are the storage instructions for GILTUSS DIABETIC EX EXPECTORANT?

Store GILTUSS DIABETIC 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 Diabetic Ex. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Giltuss Diabetic Ex.
Details

Drug Information (PDF)

This file contains official product information for Giltuss Diabetic Ex, 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 respiratory conditions characterized by excessive mucus production. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways. This action aids in making coughs more productive, thereby improving respiratory function.

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

Dosage and Administration

Patients should take this medication with a full glass of water. The tablets must not be crushed, chewed, or broken prior to ingestion. This product can be administered without regard for 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 total daily dosage should not exceed 4 tablets within a 24-hour period.

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

Contraindications

Use is contraindicated in patients who experience a cough lasting more than 7 days, a recurrent cough, or a cough accompanied by fever, rash, or persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Warnings and Precautions

Use of this medication is contraindicated in children under 12 years of age.

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

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

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is contraindicated in children under 12 years of age.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their cough 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.

Additionally, patients should seek medical advice prior to using this medication if they have a persistent or chronic cough, which may be associated with smoking, asthma, chronic bronchitis, or emphysema. Caution is also advised for those experiencing a cough that is accompanied by excessive phlegm (mucus).

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 Diabetic Ex. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Giltuss Diabetic Ex.
Details

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this population, and use is contraindicated for children in this age group.

Geriatric Use

There is no specific information regarding the use of GILTUSS DIABETIC EX in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 no specific information regarding dosage adjustments or monitoring provided in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance necessitates careful consideration of potential risks and benefits. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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, including airway management, oxygen supplementation, and intravenous fluids.

If the specific agent involved in the overdose is known, appropriate antidotes or treatments should be administered as per established guidelines. Continuous monitoring of the patient’s condition is crucial, and further interventions may be required based on the evolving clinical picture.

It is advisable for healthcare professionals to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, ensuring that the most effective and evidence-based treatment strategies are employed.

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

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. In the event of an accidental overdose, patients should be instructed to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222 for guidance. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

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 Diabetic Ex, 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 Diabetic Ex, 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.