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Giltuss Childrens Cough and Chest Congestion

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Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 10 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2018
Label revision date
October 9, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 10 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
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 2018
Label revision date
October 9, 2025
Manufacturer
Gil Pharmaceutical Corp
Registration number
M012
NDC root
58552-133
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® is a children's cough and chest congestion medication designed to help relieve symptoms associated with the common cold and inhaled irritants. It works as both an antitussive (cough suppressant) and an expectorant, which means it not only reduces the intensity of coughing but also helps loosen phlegm (mucus) and thin bronchial secretions. This makes it easier for children to cough productively and clear their airways, allowing for better sleep and comfort.

This non-drowsy, alcohol-free syrup comes in a pleasant raspberry flavor and is specifically formulated for children. It temporarily alleviates cough due to minor throat and bronchial irritation, making it a supportive option for managing cough and chest congestion.

Uses

If you or your child are dealing with a cough caused by minor throat and bronchial irritation from the common cold or other irritants, this medication can help. It temporarily relieves coughing, making it easier to manage during the day and at night, so your child can get a good night's sleep.

Additionally, this medication works to reduce the intensity of coughing and helps loosen phlegm (mucus) and thin bronchial secretions. This makes the cough more productive, allowing for better drainage of the bronchial tubes.

Dosage and Administration

When using this medication, it's important to follow the correct dosage to ensure safety and effectiveness. For children under 2 years old, you should consult a doctor before administering any doses. If your child is between 2 and 6 years old, give them 2.5 mL (milliliters) every 4 hours. For children aged 6 to under 12 years, the dose increases to 5 mL every 4 hours. If your child is 12 years or older, they can take 10 mL every 4 hours.

Make sure to use the enclosed dosing cup to measure the medication accurately, and keep this cup for future use with the product. Remember, you should not take more than 6 doses in a 24-hour period to avoid any potential risks.

What to Avoid

You should avoid using this product if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications often prescribed for depression, psychiatric conditions, or Parkinson's disease. It's also important not to use this product for at least two weeks after stopping an MAOI. If you're unsure whether your child's medication includes an MAOI, please consult a doctor or pharmacist before proceeding.

Additionally, when using this product, make sure to follow the dosage instructions carefully and do not exceed the recommended amount. Misuse or taking more than directed can lead to serious health issues, including dependence (a condition where the body becomes reliant on a substance). Always prioritize safety and seek guidance if you have any questions.

Side Effects

You should be aware of some important side effects and warnings when using this medication for your child. Do not use it if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication for depression or certain other conditions, or if they have stopped taking an MAOI within the last two weeks.

Before using this product, consult a doctor if your child has a cough with excessive mucus or any breathing issues, including a persistent cough like that seen in asthma. If your child's symptoms do not improve within seven days, or if they develop a fever, rash, or persistent headache, stop using the medication and seek medical advice, as these could indicate a more serious condition. Always follow the dosing instructions carefully, and in case of an overdose, contact a medical professional or Poison Control Center immediately.

Warnings and Precautions

You should not use this medication if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of drug used for depression or certain other conditions, or if they have stopped taking an MAOI within the last two weeks. If you're unsure whether your child's medication includes an MAOI, please consult a doctor or pharmacist before proceeding.

Before giving this medication, it's important to check with a doctor if your child has a cough with excessive mucus, a breathing problem, or a persistent cough, such as one associated with asthma. If your child does not improve within 7 days, develops a fever, or if the cough returns with fever, rash, or a persistent headache, stop using the medication and contact a doctor or pharmacist, as these may indicate a more serious issue.

In the event of an overdose, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Don’t wait to see if symptoms improve; prompt action is essential for your safety. Always keep emergency contact information handy, and remember that getting help quickly can make a significant difference.

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

If you have a child under 2 years old, it's important to consult a doctor before giving them this medication. For children aged 2 to under 6 years, the recommended dose is 2.5 mL every 4 hours. If your child is between 6 and 12 years old, they can take 5 mL every 4 hours. For those 12 years and older, the dosage increases to 10 mL every 4 hours. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about its effects or safety for this age group. 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 assess any potential risks and determine the best approach based on individual health needs.

Always keep in mind that older adults may have different responses to medications due to factors like age-related changes in the body and existing health conditions. Therefore, close monitoring and open communication with your healthcare team are essential to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to talk to your healthcare provider about any medications your child is currently taking. Specifically, if your child is on a prescription monoamine oxidase inhibitor (MAOI), a type of medication used to treat certain mental health conditions, you should avoid using this medication. This includes not using it while taking the MAOI and for at least two weeks after stopping it, as this could lead to serious interactions.

Always keep your healthcare provider informed about all medications and treatments your child is receiving. This helps ensure their safety and the effectiveness of their care.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature, ideally between 15° and 30°C (59° and 86°F). Always make sure to close the cap tightly after use to maintain its integrity. It's important to check the safety seal before using the product; do not use it if the seal is broken or missing, as this could compromise its safety and effectiveness.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Always keep this medication out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center immediately.

FAQ

What is GILTUSS® used for?

GILTUSS® is used to temporarily relieve cough and chest congestion due to minor throat and bronchial irritation associated with the common cold or inhaled irritants.

How does GILTUSS® work?

GILTUSS® acts as an antitussive (cough suppressant) and expectorant, reducing the intensity of coughing and helping to loosen phlegm (mucus) to make coughs more productive.

What is the recommended dosage for children?

For children 2 to under 6 years, the dosage is 2.5 mL every 4 hours; for children 6 to under 12 years, it's 5 mL every 4 hours; and for children 12 years and over, it's 10 mL every 4 hours.

Are there any contraindications for using GILTUSS®?

Do not use GILTUSS® if your child is taking a prescription monoamine oxidase inhibitor (MAOI) or has taken one within the last 2 weeks.

What should I do if my child's symptoms do not improve?

If your child's symptoms do not improve within 7 days or are accompanied by fever, you should stop use and consult a doctor.

Is GILTUSS® safe for children under 2 years?

Consult a doctor before using GILTUSS® for children under 2 years of age.

What should I do in case of an overdose?

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

Can I use GILTUSS® if I am pregnant or breastfeeding?

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

What are the storage instructions for GILTUSS®?

Store GILTUSS® at room temperature between 15°-30°C (59°-86°F) and keep the cap tightly closed.

Packaging Info

Below are the non-prescription pack sizes of Giltuss Childrens Cough and Chest Congestion (dextromethorphan hydrobromide, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Giltuss Childrens Cough and Chest Congestion.
Details

Drug Information (PDF)

This file contains official product information for Giltuss Childrens Cough and Chest Congestion, 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 cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants. It is effective in reducing the intensity of coughing and decreasing the impulse to cough, thereby assisting children in achieving restful sleep. Additionally, this medication helps to loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and facilitating the drainage of bronchial tubes.

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

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. Healthcare professionals should instruct patients to utilize the enclosed dosing cup for accurate measurement and to retain it for future use with this product.

For pediatric patients, the following dosing guidelines apply:

  • For children under 2 years of age, consultation with a physician is advised prior to administration.

  • For children aged 2 to under 6 years, the recommended dose is 2.5 mL every 4 hours.

  • For children aged 6 to under 12 years, the recommended dose is 5 mL every 4 hours.

  • For patients aged 12 years and older, the recommended dose is 10 mL every 4 hours.

It is essential to adhere to these dosing recommendations to ensure safety and efficacy.

Contraindications

Use of this product is contraindicated in children currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a child's prescription medication, consultation with a healthcare professional is advised prior to use.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

Do not administer this product to children currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this product should not be used for at least two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a child's prescription includes an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

Before using this product, it is advisable to consult a healthcare provider if the child presents with a cough that is productive of excessive phlegm (mucus) or has a history of breathing problems, including persistent or chronic cough associated with asthma.

Parents and caregivers should discontinue use and seek medical advice if the child experiences any of the following: symptoms that do not improve within seven days, symptoms accompanied by fever, or a recurrence of cough that is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires medical evaluation.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious warnings include the contraindication of use in children currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication, as this may lead to significant interactions.

Before using this product, it is advisable to consult a healthcare professional if the child has a cough that produces excessive phlegm, a breathing problem, or a persistent or chronic cough, such as that which occurs with asthma.

Patients are instructed to discontinue use and seek medical advice if symptoms do not improve within seven days, or if they are accompanied by fever. Additionally, if the cough recurs or is associated with fever, rash, or a persistent headache, these may indicate a serious underlying condition that requires further evaluation.

While using this product, it is crucial to adhere strictly to the recommended dosage and not exceed the directed amount. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

The use of this medication is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing an MAOI. Co-administration may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for this medication. Therefore, no specific dosage adjustments or monitoring recommendations are necessary beyond the aforementioned contraindication.

Packaging & NDC

Below are the non-prescription pack sizes of Giltuss Childrens Cough and Chest Congestion (dextromethorphan hydrobromide, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Giltuss Childrens Cough and Chest Congestion.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 to under 6 years, the recommended dosage is 2.5 mL every 4 hours. In children aged 6 to under 12 years, the dosage increases to 5 mL every 4 hours. For adolescents aged 12 years and over, the recommended dosage is 10 mL every 4 hours.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the variability in pharmacokinetics and pharmacodynamics that may occur with aging. Additionally, consideration should be given to the presence of comorbidities and the potential for polypharmacy in this population, which may necessitate dosage adjustments or increased monitoring.

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 on the excretion of this drug 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, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. 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 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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

Postmarketing experience has revealed reports of adverse reactions, including allergic reactions such as rash, urticaria, and angioedema. These events were reported voluntarily or identified through surveillance programs.

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 overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

It is important to inform patients that this product should not be used if their child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking an MAOI drug within the last two weeks. Patients should be encouraged to consult with a doctor or pharmacist if they are uncertain whether their child's prescription medication contains an MAOI.

Patients should be instructed to discontinue use and consult a healthcare professional if the child experiences symptoms that do not improve within 7 days, or if symptoms are accompanied by fever. Additionally, if a cough returns or is accompanied by fever, rash, or a persistent headache, patients should seek medical advice, as these may indicate a serious condition.

While using this product, patients must be reminded not to exceed the recommended dosage. Furthermore, healthcare providers should advise patients to consult a doctor before use if the child has a cough that produces excessive phlegm (mucus) or if there are any breathing problems or a persistent or chronic cough, such as that which occurs with asthma.

Storage and Handling

The product is supplied in a configuration that includes an NDC number, which is essential for identification. It should be stored at room temperature, specifically within the range of 15° to 30°C (59° to 86°F).

To ensure the integrity of the product, the cap must be closed tightly after each use. Additionally, it is crucial to refrain from using the product if the safety seal is broken or missing, as this may compromise its safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is important to keep the medication out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Giltuss Childrens Cough and Chest Congestion, 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 Childrens Cough and Chest Congestion, 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.

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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.