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Childrens Giltuss Honey 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 2020
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 2020
Label revision date
October 9, 2025
Manufacturer
Gil Pharmaceutical Corp
Registration number
M012
NDC root
58552-141
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 honey-based cough and chest congestion remedy designed specifically for children aged 4 to 12. This alcohol-free and dye-free product temporarily relieves cough caused by minor throat and bronchial irritation, often associated with the common cold or inhaled irritants. It works by reducing the intensity of coughing and decreasing the urge to cough, which can help children sleep better. Additionally, it helps to loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive and aiding in the drainage of bronchial tubes.

With a pleasant honey lemon flavor, Children's Giltuss® is formulated to provide relief from cough and cold symptoms while also addressing chest congestion.

Uses

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

Additionally, it reduces the urge to cough, which can be especially helpful for children trying to sleep. The medication also works to loosen phlegm (mucus) and thin out bronchial secretions, making coughs more productive and helping to clear the bronchial tubes.

Dosage and Administration

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

For children, the dosage varies by age. If your child is under 4 years old, you should consult a doctor before giving them this medication. For children aged 4 to under 6 years, the recommended dose is 2.5 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 keep your child safe.

What to Avoid

You should avoid using this medication if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which are specific drugs used for depression, psychiatric, or emotional conditions, or Parkinson’s disease. Additionally, do not use this medication for at least two weeks after stopping an MAOI. If you're unsure whether your child's prescription includes an MAOI, it's important to consult with a doctor or pharmacist before proceeding with this product.

Taking this medication in conjunction with an MAOI can lead to serious health risks, so please prioritize safety and seek professional guidance if needed.

Side Effects

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

If your child experiences a cough that lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache, you should stop using the medication and consult a doctor. These symptoms could indicate a more serious health issue that needs attention.

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 medication 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 that produces a lot of mucus or a chronic cough, such as one associated with asthma. If your child's cough lasts more than seven days, returns, or is accompanied by a fever, rash, or persistent headache, stop using the medication and contact a doctor, as these may indicate a more serious issue.

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

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.

Always err on the side of caution—if you notice anything concerning, don’t hesitate to reach out for professional assistance. Your health and safety are the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or warnings regarding the use of Children's Giltuss Honey Cough and Chest Congestion during pregnancy. The information available does not indicate any risks or contraindications associated with this product for pregnant individuals. Additionally, there are no recommended dosage modifications for those who are pregnant, and no special precautions are noted.

As always, it's a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

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 it may pose 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: do not give this medication if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks. Always check with a doctor if your child has a cough with excessive mucus, a chronic cough like asthma, or if the cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache.

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, discussing any concerns with a healthcare professional is essential to ensure safe and effective use.

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.

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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be cautious when it comes to medications, especially for children. If your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), a type of medication used to treat certain mental health conditions, you should not use this drug. Additionally, you should wait at least two weeks after stopping the MAOI before starting this medication, as taking them together can lead to serious interactions.

Always discuss any medications your child is taking with a healthcare provider. They can help ensure that all treatments are safe and effective, and they can provide guidance on any potential risks. Your child's health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 15°-30°C (59°-86°F). It's important to keep the cap tightly closed to maintain its integrity. Additionally, remember to save the carton, as it contains important information about the drug, including complete drug facts that you may need later.

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

Additional Information

You should take this medication orally. It's important to 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. Additionally, if you experience any side effects, be sure to call your doctor for advice.

FAQ

What is Children's Giltuss® used for?

Children's Giltuss® is used to temporarily relieve cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants.

What age group is Children's Giltuss® intended for?

Children's Giltuss® is intended for children aged 4 to 12 years.

How should I dose Children's Giltuss® for my child?

For children 4 to under 6 years, give 2.5 mL every 4 hours; for children 6 to under 12 years, give 5 mL every 4 hours; and for children 12 years and over, give 10 mL every 4 hours. Do not exceed 6 doses in any 24-hour period.

Are there any contraindications for using Children's Giltuss®?

Do not use Children's Giltuss® if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping the MAOI drug.

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

Stop use and ask a doctor if your child's cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

Is Children's Giltuss® safe to use during pregnancy?

The insert does not mention any contraindications or risks associated with the use of Children's Giltuss® during pregnancy.

Can nursing mothers use Children's Giltuss®?

There are no specific warnings or recommendations regarding the use of Children's Giltuss® in nursing mothers.

What are the storage instructions for Children's Giltuss®?

Store Children's Giltuss® at room temperature between 15°-30°C (59°-86°F) and close the cap tightly.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

Packaging Info

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

Packaging configurations for Childrens Giltuss Honey Cough and Chest Congestion.
Details

Drug Information (PDF)

This file contains official product information for Childrens Giltuss Honey 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 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. Administration should be performed using the enclosed dosing cup, which should be retained for future use with this product.

For pediatric patients, the following dosage recommendations apply:

  • For children under 4 years of age, consultation with a healthcare professional is advised prior to administration.

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

It is essential to adhere to these guidelines to ensure safe and effective use of the product.

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 the child's prescription medication, consultation with a healthcare professional is advised prior to administration of this product.

Warnings and Precautions

The use of this product is contraindicated in children currently taking prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be administered for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise caregivers to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

Before administering this product, it is essential to consult a healthcare provider if the child presents with a cough that is productive of excessive phlegm (mucus) or if there is a history of a persistent or chronic cough, such as that associated with asthma. These conditions may necessitate further evaluation and management.

Caregivers should be instructed to discontinue use and seek medical advice if the child experiences a cough lasting more than seven days, if the cough recurs, or if it is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires prompt medical attention.

In the event of an overdose, immediate medical assistance should be sought, or the caregiver should contact a Poison Control Center without delay to ensure the safety and well-being of the child.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may occur, particularly in children who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. The use of this medication in such cases is contraindicated.

In clinical practice, it is advised that caregivers stop the use of this medication and consult a healthcare professional if the child experiences a cough that persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Monitoring for these adverse reactions is essential to ensure the safety and well-being of patients during treatment.

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 contraindication mentioned.

Packaging & NDC

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

Packaging configurations for Childrens Giltuss Honey Cough and Chest Congestion.
Details

Pediatric Use

Pediatric patients under 4 years of age should consult a doctor 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.

Caution is advised when using this medication in pediatric patients. It should not be used in children currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Parents or caregivers should seek medical advice before use if the child has a cough associated with excessive phlegm (mucus) or a persistent cough, such as that seen in asthma. Additionally, if a child's cough lasts longer than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, use should be discontinued and a doctor consulted.

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, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and concurrent medications that are common in this population, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

There are no specific statements regarding the use of Children's Giltuss Honey Cough and Chest Congestion during pregnancy. The available information does not indicate any contraindications or risks associated with the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided, nor does the insert include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the benefits against any potential risks.

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

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 lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 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 vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of the symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

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

Postmarketing experience has identified a range of adverse reactions associated with the product. These include allergic reactions such as rash, pruritus, and urticaria; neurological effects including dizziness, confusion, somnolence, and hallucinations; gastrointestinal disturbances such as nausea and vomiting; and psychological symptoms including agitation. Additionally, respiratory depression, serotonin syndrome, increased heart rate, hypertension, and hepatotoxicity have been reported. Anaphylaxis has also been noted among the adverse reactions.

Reports of these adverse reactions have been received from various sources, including spontaneous reports, literature, and clinical trials. The frequency of these adverse reactions is not known, and it is important to note that other adverse reactions not listed above may also occur. The safety profile of the product may evolve as further postmarketing data becomes available.

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, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed that this medication should not be used if their child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain drugs prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, it should not be used for at least 2 weeks after discontinuing an MAOI. If there is uncertainty regarding whether a child's prescription contains an MAOI, patients should be encouraged to consult with a doctor or pharmacist prior to using this product.

Healthcare providers should instruct patients to discontinue use and consult a doctor if the child experiences a cough that persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition.

Furthermore, patients should be advised to seek medical guidance before using this medication if the child has a cough that produces excessive phlegm (mucus) or if the child has a persistent or chronic cough, such as that associated with asthma.

Storage and Handling

The product is supplied in a configuration that includes a tightly sealed cap to ensure integrity. It is essential to store the product at room temperature, specifically within the range of 15° to 30°C (59° to 86°F). Healthcare professionals are advised to retain the carton for complete drug facts and additional information. Proper handling and storage conditions are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. Patients are also encouraged to consult their doctor for medical advice should they experience any side effects.

Drug Information (PDF)

This file contains official product information for Childrens Giltuss Honey 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 Childrens Giltuss Honey 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.

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.