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Giltuss Tr

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Active ingredients
  • Guaifenesin 390 mg
  • Dextromethorphan Hydrobromide 29 mg
  • Phenylephrine Hydrochloride 10 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
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 2022
Label revision date
October 9, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 390 mg
  • Dextromethorphan Hydrobromide 29 mg
  • Phenylephrine Hydrochloride 10 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
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 2022
Label revision date
October 9, 2025
Manufacturer
Gil Pharmaceutical Corp
Registration number
M012
NDC root
58552-335
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 is a medication designed to temporarily relieve symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies. It works by helping to loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive. Additionally, Giltuss helps clear nasal passageways, reduces nasal congestion, and shrinks swollen membranes, providing you with relief from discomfort caused by these conditions.

Uses

If you're dealing with a cough, the common cold, hay fever, or other upper respiratory allergies, this medication can provide temporary relief from your symptoms. It works by helping to loosen phlegm (mucus) and nasal congestion, making it easier for you to breathe and cough effectively.

Additionally, it thins bronchial secretions, which helps drain the bronchial tubes and makes your coughs more productive. This means you can clear your stuffy nose and nasal passageways more easily, while also reducing swelling in the membranes of your nasal passages.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 1 tablet every 6 to 8 hours as needed. However, make sure not to take more than 4 tablets in a 24-hour period. For children between the ages of 6 and 12, the recommended dose is 1/2 tablet every 6 to 8 hours, with a maximum of 2 tablets in a 24-hour period.

If your child is under 6 years old, it’s important to consult a doctor before giving them this medication. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to be aware of certain situations where you should stop using this medication and consult your doctor. If you experience nervousness, dizziness, or sleeplessness, or if your symptoms are accompanied by fever, rash, persistent headache, or excessive mucus, you should seek medical advice. Additionally, if your cough and congestion do not improve within 7 days or if they tend to come back, it's best to talk to your healthcare provider.

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

Side Effects

It's important to be aware of potential side effects when using this product. You should stop using it and consult a doctor if you experience nervousness, dizziness, or sleeplessness. Additionally, if these symptoms are accompanied by fever, rash, a persistent headache, or excessive mucus, or if your cough and congestion do not improve within 7 days or keep coming back, these could indicate a more serious condition.

Before using this product, talk to your doctor if you have any of the following: heart disease, high blood pressure, diabetes, thyroid disease, difficulty urinating due to an enlarged prostate, or a chronic cough from smoking, asthma, chronic bronchitis, or emphysema. Also, avoid using this product if you are currently taking a prescription Monoamine Oxidase Inhibitor (MAOI) or have stopped taking one within the last two weeks, as this could lead to serious interactions.

Warnings and Precautions

It's important to use this product only as directed and not to exceed the recommended dosage. Avoid using it if you are currently taking a prescription Monoamine Oxidase Inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, or if you have stopped taking an MAOI within the last two weeks. If you're unsure whether your medication includes an MAOI, please consult a healthcare professional.

You should stop using this product and contact your doctor if you experience nervousness, dizziness, or sleeplessness. Additionally, seek medical advice if these symptoms are accompanied by fever, rash, a persistent headache, or excessive mucus. If your cough and congestion do not improve within seven days or keep coming back, these could be signs of a more serious issue that requires attention.

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 signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

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 and any medications you may consider.

Pediatric Use

When giving this medication to children aged 6 to 12 years, you should administer half a tablet every 6 to 8 hours, but make sure not to exceed 2 tablets in a 24-hour period. For children under 6 years old, it’s important to consult a doctor before giving this medication, as specific guidance is needed for their safety. Always follow these recommendations to ensure your child's well-being.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for your kidney health.

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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition effectively.

Make sure to keep them informed about any liver issues you may have, as they can help ensure that your treatment is safe and appropriate for you.

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 avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature, following the standards set by the United States Pharmacopeia (USP). It's important to check the safety seal under the cap before use; do not use the product if this seal is broken or missing, as this could indicate that the product is compromised.

By following these simple storage and handling guidelines, you can help maintain the integrity and effectiveness of the product. Always prioritize safety to ensure a positive experience.

Additional Information

No further information is available.

FAQ

What is Giltuss used for?

Giltuss temporarily relieves symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies.

How does Giltuss work?

Giltuss helps loosen phlegm (mucus), clears nasal passageways, thins bronchial secretions, and makes coughs more productive.

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

Adults and children 12 years and over should take 1 tablet every 6 to 8 hours, not exceeding 4 tablets in 24 hours.

What is the recommended dosage for children aged 6 to 12?

Children aged 6 to 12 years should take 1/2 tablet every 6 to 8 hours, not exceeding 2 tablets in 24 hours.

What should I do if I have a child under 6 years?

For children under 6 years of age, you should ask a doctor before use.

Are there any warnings associated with Giltuss?

Do not exceed the recommended dosage, and avoid using it if you are taking a prescription Monoamine Oxidase Inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

When should I stop using Giltuss and consult a doctor?

Stop use and ask a doctor if you experience nervousness, dizziness, sleeplessness, fever, rash, persistent headache, excessive phlegm, or if cough and congestion do not improve within 7 days.

Should I consult a doctor before using Giltuss?

Yes, consult a doctor if you have heart disease, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to prostate enlargement.

What should I do if I am pregnant or breastfeeding?

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

How should Giltuss be stored?

Store Giltuss at room temperature and do not use it if the imprinted safety seal under the cap is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Giltuss Tr (guaifenesin, dextromethorphan hbr, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Giltuss Tr.
Details

Drug Information (PDF)

This file contains official product information for Giltuss Tr, 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 temporary relief of symptoms associated with cough, the common cold, hay fever, and other upper respiratory allergies. It aids in loosening phlegm (mucus) and nasal congestion, thinning bronchial secretions, and draining bronchial tubes. Additionally, it enhances the productivity of coughs, clears a stuffy nose, and clears nasal passageways while shrinking swollen membranes.

Limitations of Use: This drug is intended for symptomatic relief and does not address the underlying causes of these conditions.

Dosage and Administration

For adults and children aged 12 years and over, the recommended dosage is 1 tablet every 6 to 8 hours as needed. The total daily dosage should not exceed 4 tablets within a 24-hour period.

For children aged 6 to 12 years, the recommended dosage is 1/2 tablet every 6 to 8 hours as needed. The total daily dosage for this age group should not exceed 2 tablets within a 24-hour period.

For children under 6 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

There are no specified contraindications for this product. However, it is advised to discontinue use and consult a healthcare professional if any of the following occur: nervousness, dizziness, or sleeplessness; symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm; or if cough and congestion do not improve within 7 days or tend to recur.

Warnings and Precautions

Patients should adhere strictly to the recommended dosage of this product. It is contraindicated for use in conjunction with prescription Monoamine Oxidase Inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s Disease. Additionally, this product should not be used for a minimum of two weeks following the discontinuation of an MAOI. Healthcare professionals should be consulted if there is any uncertainty regarding the presence of an MAOI in a patient's current medication regimen.

Patients are advised to discontinue use and seek medical attention if they experience any of the following symptoms: nervousness, dizziness, or sleeplessness. Furthermore, if these symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus), immediate consultation with a healthcare provider is warranted. It is also important to monitor for cough and congestion that do not improve within seven days or that tend to recur, as these may indicate a serious underlying condition. Regular assessment and appropriate laboratory tests may be necessary to ensure patient safety and effective management of symptoms.

Side Effects

Patients using this product may experience a range of adverse reactions. Serious adverse reactions may include nervousness, dizziness, or sleeplessness. If any of these symptoms occur, patients are advised to stop use and consult a healthcare professional. Additionally, if symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm, or if cough and congestion do not improve within 7 days or tend to recur, these may indicate a serious condition requiring medical attention.

It is important to note that this product should not be used in conjunction with prescription Monoamine Oxidase Inhibitors (MAOIs) or within 2 weeks of stopping such medication, as this could lead to serious interactions.

Patients with pre-existing conditions should seek medical advice before using this product if they have heart disease, excessive phlegm, high blood pressure, diabetes, thyroid disease, difficulty urinating due to prostate enlargement, or 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 Tr (guaifenesin, dextromethorphan hbr, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Giltuss Tr.
Details

Pediatric Use

Pediatric patients aged 6 to 12 years may be administered 1/2 tablet every 6 to 8 hours, with a maximum dosage not to exceed 2 tablets in a 24-hour period. For children under 6 years of age, it is advised to consult a doctor before use.

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, 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

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 regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory depression, or other neurological manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or a medical toxicologist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected overdose.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use.

In the event of experiencing nervousness, dizziness, or sleeplessness, it is recommended to discontinue use and seek medical advice. Additionally, if these symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm, medical consultation should also be sought. Users should stop use and consult a doctor if cough and congestion do not improve within seven days or if symptoms tend to recur, as these may indicate a serious condition.

No information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include nervousness, dizziness, sleeplessness, fever, rash, persistent headache, and excessive phlegm (mucus).

Patient Counseling

Healthcare providers should advise patients to discontinue use and seek medical attention if they experience nervousness, dizziness, or sleeplessness. Patients should also be informed to contact a doctor if their symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm, as these may indicate a serious condition. Additionally, if cough and congestion do not improve within 7 days or tend to recur, patients should be encouraged to consult a healthcare professional.

Before initiating use, healthcare providers should recommend that patients discuss their medical history, particularly if they have heart disease, excessive phlegm, high blood pressure, diabetes, thyroid disease, or difficulty urinating due to an enlarged prostate gland. It is also important to inquire about any persistent or chronic cough, especially in patients with a history of smoking, asthma, chronic bronchitis, or emphysema, as these conditions may require special consideration.

Storage and Handling

The product is supplied in a configuration that includes an imprinted safety seal under the cap. It is essential to ensure that this seal is intact before use, as the product should not be utilized if the seal is broken or missing.

For optimal storage conditions, the product must be kept at room temperature, in accordance with USP guidelines. Proper handling and storage are crucial to maintain 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 Tr, 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 Tr, 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.