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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
September 24, 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
September 24, 2025
Manufacturer
Dextrum Laboratories, Inc
Registration number
M012
NDC root
65852-003
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 Honey is a cough and chest congestion remedy designed specifically for children. This alcohol-free and dye-free syrup features a pleasant honey lemon flavor and is made with true source certified honey. It works by liquifying and loosening phlegm and mucus, helping to relieve cough and cold symptoms effectively.

This product is suitable for children aged 4 years and older, providing a non-drowsy option for easing discomfort associated with coughs and chest congestion. With its gentle formulation, Children's Giltuss Honey aims to support your child's respiratory health while making the experience more pleasant.

Uses

If you're dealing with a cough or cold, this medication can help by relieving chest congestion. It works by liquefying (thinning) and loosening phlegm and mucus, making it easier for you to breathe and feel more comfortable.

You can use this medication to help clear your airways and alleviate the discomfort associated with respiratory issues. It's important to note that there are no reported 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. For adults and children aged 12 years and older, you should take 10 ml every 4 hours, but remember not to exceed 6 doses in a 24-hour period. If you're giving this medication to children, use the enclosed dosing cup to measure the correct amount.

For children aged 6 to under 12 years, the dosage is 5 ml every 4 hours, while for those aged 4 to under 6 years, the recommended dose is 2.5 ml every 4 hours. If your child is under 4 years old, it's best to consult a doctor before administering this medication. Make sure to keep the dosing cup for future use with this product to ensure accurate measurements.

What to Avoid

It's important to use this medication safely. Keep it out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help or contact a Poison Control center right away.

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

Side Effects

You should be aware of some important side effects and warnings associated with this medication. If your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, do not use this medication, and wait at least two weeks after stopping the MAOI before starting it.

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 consult a doctor, as these may indicate a more serious condition. Additionally, consult a doctor before use if your child has a cough with excessive mucus or a chronic cough, such as that seen in asthma.

Warnings and Precautions

You should not use this product 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.

It's important to talk to a doctor before using this product if your child has a cough that produces a lot of mucus or if they have a chronic cough, such as one associated with asthma. If your child accidentally takes too much of this medication, seek emergency medical help or contact a Poison Control center right away. Additionally, you should stop using the product and call your doctor if your child's cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious issue.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general 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, you should contact your local emergency services or go to the nearest hospital right away. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it’s better to err on the side of caution and seek help.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety concerns mentioned regarding the use of Children's Giltuss Honey Cough and Chest Congestion during pregnancy. The information provided does not indicate any contraindications (situations where the product should not be used) or special precautions for pregnant individuals. Additionally, there are no recommended dosage modifications for those who are pregnant.

As always, it's best 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.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

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, while children aged 6 to under 12 years can take 5 ml every 4 hours. Remember, no child should take more than 6 doses in a 24-hour period.

Before giving this medication, ask your doctor if your child has a cough with a lot of mucus or a persistent cough, such as one caused by asthma. If your child's cough lasts more than 7 days, comes back, or is accompanied by a fever, rash, or persistent headache, stop using the medication and consult a doctor, as these could indicate a more serious issue. Always keep the medication out of reach of children, and in case of accidental overdose, seek medical help or contact a Poison Control center immediately.

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, and factors like kidney function (how well your kidneys work) and changes in cognitive abilities (how you think and remember) can influence treatment. Your healthcare provider can guide you on the appropriate dosage and monitor for any side effects.

Renal Impairment

If you have kidney issues, it's important to know that there are no specific guidelines provided for dosage adjustments, special monitoring, or safety considerations related to your condition. This means that the information available does not outline any changes you may need to make regarding your treatment or any additional precautions you should take.

Always consult with your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your kidney health. They can help you understand how your condition may affect your medication and what steps you should take.

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 want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support 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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, ideally between 15-30 °C (59° - 86 °F). Make sure to close the cap tightly after each use to prevent contamination. It's also important to keep the original carton, as it contains complete drug facts that you may need for reference.

By following these simple storage and handling guidelines, you can help maintain the effectiveness of the product while ensuring your safety.

Additional Information

No further information is available.

FAQ

What is Children's Giltuss Honey used for?

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

What are the key features of Children's Giltuss Honey?

It is alcohol-free, dye-free, non-drowsy, and made with true source certified honey, available in a honey lemon flavor.

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.

What should I do if my child is under 4 years old?

Consult a doctor before using Children's Giltuss Honey for children under 4 years of age.

How often can I give Children's Giltuss Honey?

Do not take more than 6 doses in any 24-hour period.

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

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

Are there any warnings for using Children's Giltuss Honey?

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 in case of accidental overdose?

Get medical or professional help or contact a Poison Control center immediately.

Is there any information about using Children's Giltuss Honey during pregnancy or breastfeeding?

The product insert does not provide specific information regarding use during pregnancy or breastfeeding.

How should I store Children's Giltuss Honey?

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

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 specified drug.

Uses and Indications

This drug is indicated for the relief of cough and cold symptoms, specifically targeting chest congestion. It functions by liquefying and loosening phlegm and mucus, thereby facilitating easier expectoration.

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. The enclosed dosing cup should be utilized for accurate measurement, and it is advised to retain this cup for future use with the product.

For pediatric patients, the following dosing guidelines apply:

  • For children under 4 years of age, consultation with a healthcare professional is required 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 adults and children aged 12 years and older, the recommended dose is 10 ml every 4 hours.

Contraindications

Use is contraindicated in the following situations:

  • Keep out of reach of children to prevent accidental ingestion.

  • In the event of an accidental overdose, seek medical assistance or contact a Poison Control center immediately.

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

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions when considering the use of this product.

Warnings The use of this product is contraindicated in children who are 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 administered for a period of two weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is essential to consult a healthcare professional, such as a doctor or pharmacist, prior to use.

General Precautions Healthcare professionals should advise caregivers to seek medical guidance before administering this product if the child presents with a cough that is accompanied by excessive phlegm (mucus) or if the cough is persistent or chronic, as may occur in cases of asthma.

Emergency Situations In the event of an accidental overdose, immediate medical assistance should be sought. Caregivers are encouraged to contact a Poison Control center or seek professional medical help without delay.

Monitoring and Discontinuation Caregivers should be vigilant and discontinue use while consulting a healthcare provider if the child's cough persists for more than seven days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions may necessitate immediate medical attention. Patients should discontinue use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious underlying condition.

In addition, caution is advised when considering this medication for children who have a cough that occurs with excessive phlegm or a persistent cough, such as that associated with asthma. The use of this medication is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, as this combination may lead to serious adverse effects.

It is essential for patients and caregivers to be aware of these warnings and to seek medical advice when necessary to ensure safe and effective use of the medication.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of 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, while children aged 6 to under 12 years may receive 5 ml every 4 hours. It is important not to exceed 6 doses within a 24-hour period.

Healthcare professionals should advise parents to seek medical advice if their child has a cough associated with excessive phlegm (mucus) or a persistent cough, such as that which occurs with asthma. Additionally, parents should be instructed to discontinue use and consult a doctor if the cough lasts longer than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition.

It is essential to keep this medication out of reach of children. In the event of an accidental overdose, immediate medical assistance or contact with a Poison Control center is necessary.

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 may affect treatment outcomes in this population.

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 safety concerns, contraindications, or special precautions associated with the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are provided. Healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies in the event of an overdose.

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 use of the compound in these contexts.

Postmarketing Experience

Reports of adverse reactions associated with the use of this product have been received through voluntary reporting and surveillance programs. Notable adverse events include allergic reactions, skin rash, dizziness, nausea, vomiting, diarrhea, abdominal pain, somnolence, agitation, hallucinations, confusion, increased heart rate, high blood pressure, and respiratory depression.

Ongoing monitoring of postmarketing data has resulted in updates to the labeling to incorporate new safety information. Healthcare professionals and consumers are encouraged to report any adverse events or side effects to the appropriate health authorities.

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 accidental overdose, patients should be instructed to seek medical assistance or contact a Poison Control center immediately. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

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

To ensure the integrity of the product, the cap must be closed tightly after each use. Additionally, it is recommended to save the carton for complete drug facts, which may be necessary for future reference. Proper handling and storage conditions are crucial for maintaining the product's efficacy and safety.

Additional Clinical Information

No further data are available.

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.

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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.