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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 6, 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 6, 2025
Manufacturer
Dextrum Laboratories, Inc
Registration number
M012
NDC root
65852-019
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

Children's Giltuss is a medication designed to help relieve cough and chest congestion in children. It works by liquifying and loosening phlegm and mucus, making it easier for your child to clear their airways. This product is alcohol-free, sugar-free, and dye-free, and it comes in a pleasant raspberry flavor, ensuring that it is gentle and palatable for young ones.

This non-drowsy formula is suitable for children aged 4 years and older, with specific dosage recommendations based on age. If your child is under 4 years old, it's important to consult a doctor before use.

Uses

If you're dealing with a cough and chest congestion, this medication can help. It works by liquifying and loosening phlegm and mucus, making it easier for you to clear your airways. This can provide relief from the discomfort associated with these symptoms, helping you breathe more easily.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication.

Dosage and Administration

When using this medication, it's important to follow the correct dosage to ensure safety and effectiveness. You should not take more than 6 doses within a 24-hour period. To measure your dose accurately, use the enclosed dosing cup, and remember to keep it for future use with this product.

For children, the dosage varies by age. If your child is under 4 years old, it's best to consult a doctor before giving them this medication. For children aged 4 to under 6 years, the recommended dose is 2.5 milliliters (ml) every 4 hours. If your child is between 6 and under 12 years, they should take 5 ml every 4 hours. For those 12 years and older, the dosage increases to 10 ml every 4 hours. Always ensure you are measuring the dose correctly to provide the best care.

What to Avoid

It's important to be aware of certain guidelines when using this medication. If your child has symptoms that do not improve within 7 days, or if they develop a fever, a cough that returns with fever, a rash, or a persistent headache, you should stop using the medication and consult a doctor or pharmacist for further advice.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always prioritize your child's health and seek professional guidance if you have any concerns.

Side Effects

If your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, or has stopped taking one within the last two weeks, do not use this product. It's important to consult a doctor or pharmacist if you're unsure whether your child's medication includes an MAOI.

You should stop using this product and seek medical advice if your child's symptoms do not improve within 7 days, or if they develop a fever, a cough that returns with fever, a rash, or a persistent headache. Additionally, consult a doctor before use if your child has a cough with a lot of mucus or any breathing issues, including a chronic cough associated with asthma.

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, certain psychiatric conditions, or Parkinson's disease. Additionally, wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your child's medication contains an MAOI, please consult a doctor or pharmacist.

It's important to be cautious. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center. You should also stop using the medication and reach out to a doctor or pharmacist if your child's symptoms do not improve within seven days, or if they experience a fever, a returning cough with fever, a rash, or a persistent headache.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking more than the recommended dose. If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, you should seek immediate medical attention. Contact your healthcare provider or go to the nearest emergency room. If possible, have the medication packaging with you to help medical professionals understand what you've taken. Always remember that it's better to be safe and get help if you have any concerns about your health.

Pregnancy Use

The information regarding the use of Giltuss Children's Cough and Chest Congestion during pregnancy is limited. The insert does not provide specific guidance on its use while pregnant, nor does it mention any safety concerns or contraindications. Additionally, there are no dosage modifications or special precautions noted for pregnant individuals.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication, including over-the-counter products like Giltuss. They can help you make informed decisions based on your individual health needs.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is under 4 years old, it's important to consult a doctor before using this medication. For children aged 4 to under 6 years, the recommended dose is 2.5 ml every 4 hours. For those aged 6 to under 12 years, the dose increases to 5 ml every 4 hours, and for children 12 years and older, the dose is 10 ml every 4 hours.

Be cautious if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), as this medication should not be used while on an MAOI or for 2 weeks after stopping it. Always check with a doctor before use if your child has a cough with a lot of mucus, breathing issues, or a persistent cough, such as one that occurs with asthma. If your child's symptoms do not improve within 7 days, or if they develop a fever, a returning cough, a rash, or a persistent headache, stop using the medication and consult a doctor or pharmacist.

Geriatric Use

While there is no specific information about the use of this medication in older adults, it’s important to remember that each person’s health needs can vary. Since the insert does not mention any age-related dosage adjustments, safety concerns, or special precautions for elderly patients, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is appropriate for your individual health situation and any other medications you may be taking.

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 for patients with renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 function. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to be cautious when it comes to medications, especially if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks. Using this medication during that time can lead to serious interactions that could affect your child's health.

Always discuss any medications your child is taking with their healthcare provider. This ensures that you are aware of any potential risks and can make informed decisions about their treatment. Your healthcare provider can help you navigate these interactions safely.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. Before giving it to a child, consult a doctor if the child has a cough with a lot of mucus, any breathing issues, or a chronic cough, such as one related to asthma. If the child's symptoms do not improve within 7 days, or if they develop a fever, a rash, or a persistent headache, stop using the medication and contact a doctor or pharmacist for further advice.

FAQ

What is Children's Giltuss used for?

Children's Giltuss is used to relieve cough and chest congestion by liquifying and loosening phlegm and mucus.

Is Children's Giltuss safe for children under 4 years?

For children under 4 years, you should consult a doctor before use.

What is the recommended dosage for children aged 4 to under 6 years?

Children aged 4 to under 6 years should take 2.5 ml every 4 hours.

How much Children's Giltuss can children aged 6 to under 12 years take?

Children aged 6 to under 12 years can take 5 ml every 4 hours.

What is the dosage for children 12 years and older?

Children 12 years and older should take 10 ml every 4 hours.

Are there any warnings for using Children's Giltuss?

Do not use if your child is taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI.

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

Stop use and ask a doctor or pharmacist if symptoms do not improve within 7 days or are accompanied by fever, rash, or persistent headache.

Is Children's Giltuss alcohol-free?

Yes, Children's Giltuss is alcohol-free, sugar-free, and dye-free.

What flavor does Children's Giltuss have?

Children's Giltuss has a raspberry flavor.

How should I store Children's Giltuss?

Store at room temperature, protect from light, and keep the container 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 relief of cough and chest congestion. It functions by liquefying and loosening phlegm and mucus, thereby facilitating easier expectoration.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

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, which should be retained for future use with this product.

For pediatric patients, the following dosing guidelines apply:

  • Children under 4 years: Consultation with a healthcare provider is advised prior to administration.

  • Children aged 4 to under 6 years: Administer 2.5 mL every 4 hours as needed.

  • Children aged 6 to under 12 years: Administer 5 mL every 4 hours as needed.

  • Children aged 12 years and over: Administer 10 mL every 4 hours as needed.

It is essential to adhere to the specified dosing intervals and not exceed the maximum daily limit to ensure safety and efficacy.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if the child exhibits symptoms that do not improve within 7 days, or if symptoms are accompanied by fever, recurrent cough with fever, rash, or persistent headache.

Warnings and Precautions

The use of this product is contraindicated in 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, it is advised to refrain from using this product for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should ensure that caregivers are aware of this interaction and encourage them to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

In the event of an overdose, immediate medical assistance should be sought. Caregivers are advised to contact a Poison Control Center without delay to ensure appropriate management of the situation.

Healthcare providers should instruct caregivers to discontinue use of the product and seek medical advice if the child exhibits symptoms that do not improve within seven days, or if symptoms are accompanied by fever, a recurrent cough with fever, rash, or a persistent headache. Monitoring for these symptoms is essential to ensure the child's safety and well-being.

In summary, vigilance regarding the use of this product in conjunction with MAOIs, awareness of overdose protocols, and prompt action in response to specific symptoms are critical components of safe administration.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in children who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). It is crucial to avoid the use of this product in conjunction with MAOIs or within two weeks of stopping such medication. Parents and caregivers should consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription.

Common adverse reactions may include symptoms that do not improve within 7 days or are accompanied by fever, a recurring cough with fever, rash, or a persistent headache. In such cases, it is advised to stop use and seek medical advice.

Additionally, prior to using this product, it is recommended to consult a healthcare professional if the child exhibits a cough that produces significant phlegm (mucus) or has a history of breathing problems, including persistent or chronic coughs associated with conditions such as asthma.

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 4 years of age should consult a healthcare professional before use. For children aged 4 to under 6 years, the recommended dosage is 2.5 ml every 4 hours. Children aged 6 to under 12 years may receive 5 ml every 4 hours, while those 12 years and older can be administered 10 ml every 4 hours.

It is contraindicated to use this medication in children currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. Prior to use, a healthcare professional should be consulted if the child has a cough associated with significant phlegm (mucus), any breathing problems, or a persistent or chronic cough, such as that which occurs with asthma.

Parents or caregivers should discontinue use and seek advice from a doctor or pharmacist if the child exhibits symptoms that do not improve within 7 days, or if symptoms are accompanied by fever, a recurrence of cough, or persistent headache or rash.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any age-related considerations. There are no recommended dosage adjustments or safety concerns specifically outlined for geriatric patients. Additionally, no special precautions are indicated for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering individual patient factors and potential comorbidities that may influence treatment outcomes. Regular monitoring may be warranted to ensure safety and efficacy in this demographic.

Pregnancy

The available prescribing information for Giltuss Children's Cough and Chest Congestion does not provide specific data regarding its use during pregnancy. There are no stated safety concerns or contraindications related to pregnancy, and no dosage modifications for pregnant individuals are mentioned. Additionally, the insert does not include any special precautions regarding the use of this product in pregnant patients. As such, healthcare professionals should consider the absence of specific data when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 alterations in consciousness, respiratory distress, cardiovascular instability, and other systemic effects.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and clinical status, and initiate supportive care as necessary. It is crucial to gather a detailed history of the substance involved, including the amount and route of administration, to guide further management.

Management procedures may include the administration of activated charcoal if the patient presents within an appropriate time frame and is not at risk for aspiration. In cases of severe toxicity, specific antidotes may be indicated, and consultation with a poison control center or a medical toxicologist is advised.

Continuous monitoring of the patient’s condition is essential, and healthcare providers should be prepared to implement advanced life support measures if indicated. Documentation of the incident and the management provided is also critical for ongoing patient care and for any necessary reporting to regulatory authorities.

In summary, while no specific overdosage information is provided, healthcare professionals should maintain a high index of suspicion and be prepared to act swiftly in the event of an overdose scenario.

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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is important to inform patients that they should discontinue use and consult a doctor or pharmacist if the child experiences symptoms that do not improve within 7 days, or if symptoms are accompanied by fever, a recurring cough, rash, or a persistent headache.

Additionally, healthcare providers should recommend that patients consult a doctor before using the medication if the child has a cough that produces significant phlegm (mucus) or if there are any breathing problems, including a persistent or chronic cough, such as that associated with asthma. This guidance is essential to ensure the safe and effective use of the medication.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients or caregivers to consult a doctor before use if the child has a cough accompanied by significant phlegm, any breathing issues, or a persistent cough that may be indicative of asthma.

Additionally, it is important to instruct patients to discontinue use and seek medical advice if symptoms do not improve within 7 days or if they are accompanied by fever, a recurrence of cough with fever, rash, or a persistent headache.

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.