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Guaifenesin

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Active ingredient
Guaifenesin 1200 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 1200 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
58552-341
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 MAXIMUM STRENGTH EXPECTORANT is a medication that contains guaifenesin (1200 mg), which is designed to help you manage coughs associated with mucus. 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, GILTUSS EX can aid in ridding your bronchial passageways of this congestion, providing relief and support for your respiratory health.

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 cough 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 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 with absorption. You can take this medication at any time, regardless of your meal schedule.

For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours. However, be careful not to exceed 2 tablets in a 24-hour period. This medication is not suitable for children under 12 years of age, so please keep it out of their reach.

What to Avoid

It's important to take certain precautions when using this medication. Always keep it out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop using this medication and consult your doctor if your cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a more serious condition.

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 (phlegm).

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 a fever, rash, or a persistent headache, stop taking the medication and call your doctor. These symptoms 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, if you suspect that you or someone else may have taken too much of a medication, it’s important to be aware of potential signs of an overdose. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms, or if you are unsure whether an overdose has occurred, seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any risk of 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

It’s important to know that this medication is not suitable for children under 12 years old. If your child is 12 years or older, you can give them 1 or 2 tablets every 12 hours, but make sure not to exceed 2 tablets in a 24-hour period. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking other medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach for you, considering your overall health and any other medications you may be taking. 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 be adjusted 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 any 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 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 your overall treatment plan is safe and effective.

Always discuss any other medications, supplements, or health conditions you have, as this information is crucial for your safety and well-being. Your provider can guide you on how to manage your health effectively.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 20°-25°C (68°-77°F). This temperature range helps maintain the product's quality.

When handling the product, be sure to check the packaging carefully. Do not use it if the carton is open or if the printed seal on the bottle is broken or missing, as this indicates that the product may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is GILTUSS EX MAXIMUM STRENGTH EXPECTORANT?

GILTUSS EX MAXIMUM STRENGTH EXPECTORANT is a medication that contains Guaifenesin, 1200 mg, and is used to help loosen phlegm (mucus) and thin bronchial secretions.

How does GILTUSS EX work?

It helps loosen phlegm and thins bronchial secretions, aiding in ridding the bronchial passageways of bothersome mucus and making coughs more productive.

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

Adults and children 12 years of age and over should take 1 or 2 tablets every 12 hours, not exceeding 2 tablets in 24 hours.

Can children under 12 use GILTUSS EX?

No, GILTUSS EX should not be used for children under 12 years of age.

What should I do in case of an accidental overdose?

In case of accidental overdose, get medical or professional help or contact a Poison Control Center right away at 1-800-222-1222.

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

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

Is it safe to use GILTUSS EX if I am pregnant or breastfeeding?

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

How should I take GILTUSS EX?

You should take GILTUSS EX with a full glass of water and do not crush, chew, or break the tablet.

What are the storage conditions for GILTUSS EX?

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

Packaging Info

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

Packaging configurations for Giltuss Ex Maximum Strength Expectorant.
Details

Drug Information (PDF)

This file contains official product information for Giltuss Ex Maximum Strength 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. 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 product with a full glass of water. It is important to note that the tablet must not be crushed, chewed, or broken prior to administration. This medication 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 is 2 tablets within a 24-hour period. This product is not indicated for use in children under 12 years of age.

Contraindications

Use is contraindicated in the following situations:

  • The product should be kept out of reach of children to prevent accidental ingestion.

  • In the event of an accidental overdose, immediate medical attention is required; contact a Poison Control Center at 1-800-222-1222.

  • Discontinue use and consult a healthcare professional if cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, as these 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 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 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, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Before initiating treatment, patients should seek medical advice if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, those experiencing a cough that produces excessive phlegm (mucus) should also consult a healthcare provider prior to use.

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 warranted at this time.

Packaging & NDC

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

Packaging configurations for Giltuss Ex Maximum Strength Expectorant.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours, with a maximum of 2 tablets in a 24-hour period. Care should be taken to adhere to the dosing guidelines to ensure safety and efficacy in this age group.

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

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 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

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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 a tamper-evident carton. It is essential to inspect the packaging prior to use; do not utilize the product if the carton 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°-25°C (68°-77°F). Proper adherence to these storage conditions is crucial to ensure the integrity 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 Maximum Strength 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 Maximum Strength 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.