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Childrens Giltuss Honey Dm Cough

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Active ingredient
Dextromethorphan Hydrobromide 15 mg/5 mL
Other brand names
Drug classes
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 ingredient
Dextromethorphan Hydrobromide 15 mg/5 mL
Other brand names
Drug classes
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
58552-144
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-flavored cough syrup designed to temporarily relieve coughs 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 helping to lessen the urge to cough, which can be particularly helpful for children trying to sleep.

This syrup is alcohol-free, dye-free, and non-drowsy, making it a gentle option for children. It provides persistent cough relief for up to 8 hours and is made with real honey, offering a pleasant Honey Lemon flavor.

Uses

You can use this medication to temporarily relieve a cough caused by minor throat and bronchial irritation, which often happens with the common cold or when inhaling irritants. It helps reduce the intensity of your cough, making it easier for you to manage.

If your child is having trouble sleeping due to coughing, this medication can also decrease the urge to cough, helping them get a better night's rest.

Dosage and Administration

When using this medication, it's important to follow the recommended dosage to ensure safety and effectiveness. You should not take more than 4 doses within a 24-hour period. To measure your dose accurately, use the enclosed dosing cup, which is specifically designed for this product. Remember to keep this cup for future use.

For children, the dosage varies by age. If your child is under 4 years old, 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 6 to 8 hours. For those aged 6 to under 12 years, the dose increases to 5 mL every 6 to 8 hours. If your child is 12 years or older, they can take 10 mL every 6 to 8 hours. Always ensure you are measuring the dose correctly to keep your child safe.

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, or emotional conditions, or Parkinson’s disease. Additionally, do not use this product for at least two weeks after stopping an MAOI. If you are unsure whether your child's prescription includes an MAOI, please consult a doctor or pharmacist before proceeding with this product.

It's important to follow these guidelines to prevent potential interactions and ensure your child's safety. Always prioritize open communication with healthcare professionals regarding any medications your child is taking.

Side Effects

You should be aware of some important side effects and warnings when considering 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 used for depression or certain other conditions, or if they have stopped taking an MAOI within the last two weeks. If you are unsure whether your child's medication includes an MAOI, please consult a doctor or pharmacist.

It's important to stop using the medication and seek medical advice if your child has a cough that lasts more than seven days, returns, or is accompanied by a fever, rash, or persistent headache, as these may indicate a more serious issue. Additionally, consult a doctor before use if your child has a cough with excessive mucus or a chronic cough, such as one associated with asthma. In case of an overdose, seek medical help or contact a 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 that produces a lot of mucus or if they have a persistent cough, such as one associated with asthma. If your child's cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or a persistent headache, stop using the medication and contact a doctor, as these could 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 what you would typically experience with the medication.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always keep emergency contact information handy, and remember that acting quickly can make a significant difference in your health and safety.

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 Giltuss Honey DM 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 or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, exercising caution is advised. Always prioritize your health and your baby's well-being by discussing any medications with your healthcare provider.

Pediatric Use

If your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks, do not use this medication. Before giving it to your child, consult a doctor if they have a cough with excessive 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 seek medical advice.

For dosing, children under 4 years should not use this medication without consulting a doctor. For children aged 4 to under 6 years, the recommended dose is 2.5 mL every 6 to 8 hours. For those aged 6 to under 12 years, the dose increases to 5 mL every 6 to 8 hours, and for children 12 years and older, the dose is 10 mL every 6 to 8 hours. Always follow these guidelines to ensure your child's safety.

Geriatric Use

When it comes to using Children's Giltuss Honey DM Cough, there is no specific information available about its use in older adults. This means that if you are caring for an older adult, it's important to consult with a healthcare professional before administering this medication. They can provide guidance tailored to individual health needs and any potential interactions with other medications.

Always prioritize safety and ensure that any treatment is appropriate for the specific health conditions and medications of the older adult in your care.

Renal Impairment

If you have kidney issues, 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 include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

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 provide guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition appropriately.

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

Drug Interactions

It's important to be cautious about the medications your child is taking. If your child is currently on a prescription monoamine oxidase inhibitor (MAOI), or if they have stopped taking one within the last two weeks, you should avoid using this medication. Taking these together can lead to serious interactions that could affect your child's health.

Always discuss any medications or treatments with your healthcare provider to ensure safety and effectiveness. They can help you understand potential interactions and make informed decisions about your child's care.

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®?

Children's Giltuss® is a honey-based cough syrup designed to temporarily relieve cough due to minor throat and bronchial irritation associated with the common cold or inhaled irritants.

How does Children's Giltuss® work?

It reduces the intensity of coughing and helps decrease the impulse to cough, which can assist children in getting to sleep.

Is Children's Giltuss® safe for children?

Yes, it is alcohol-free, dye-free, and non-drowsy, making it suitable for children when used as directed.

What is the recommended dosage for children?

For children 4 to under 6 years, the dosage is 2.5 mL every 6-8 hours; for children 6 to under 12 years, it's 5 mL; and for children 12 years and over, it's 10 mL, not exceeding 4 doses in 24 hours.

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

Do not use 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 experiences side effects?

Stop use and consult a doctor if your child has a cough lasting more than 7 days, or if it is accompanied by fever, rash, or persistent headache.

Can I use Children's Giltuss® during pregnancy?

There are no specific statements regarding the use of Children's Giltuss® during pregnancy, so consult a doctor before use.

Is it safe for nursing mothers to use Children's Giltuss®?

Nursing mothers should consult a doctor before using this product, as there is potential for excretion in breast milk.

How should I store Children's Giltuss®?

Store 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 Childrens Giltuss Honey Dm Cough (dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Giltuss Honey Dm Cough.
Details

Drug Information (PDF)

This file contains official product information for Childrens Giltuss Honey Dm Cough, 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.

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

Dosage and Administration

Healthcare professionals are advised to follow the dosing guidelines outlined below for the administration of this product.

For children under 4 years of age, it is imperative to consult a physician prior to administration. For children aged 4 to under 6 years, the recommended dosage is 2.5 mL every 6 to 8 hours, not to exceed 4 doses within a 24-hour period. For children aged 6 to under 12 years, the dosage increases to 5 mL every 6 to 8 hours, also adhering to the maximum of 4 doses in a 24-hour period. For individuals aged 12 years and older, the recommended dosage is 10 mL every 6 to 8 hours, with the same restriction of no more than 4 doses in any 24-hour period.

Administration should be performed using the enclosed dosing cup, which should be retained for future use with this product. Each measurement is specified in milliliters (mL).

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

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 2 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 if the child has a persistent or chronic cough, such as that associated with asthma.

Parents and caregivers should discontinue use and seek medical advice if the child experiences a cough lasting more than 7 days, if the cough recurs, or if it is accompanied by symptoms such as 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 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 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. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. It is imperative for caregivers to consult a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

Patients are advised to discontinue use and seek medical attention if the child experiences a cough that persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Before administering this product, it is recommended to consult a healthcare professional if the child has a cough associated with excessive phlegm (mucus) or a persistent or chronic cough, such as that which occurs with asthma.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Administration of this medication in patients currently taking an MAOI or within two weeks of discontinuing an MAOI may result in serious interactions. It is essential to ensure that patients are not on MAOIs before initiating treatment with this medication to avoid potential adverse effects.

Packaging & NDC

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

Packaging configurations for Childrens Giltuss Honey Dm Cough.
Details

Pediatric Use

Pediatric patients should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of stopping an MAOI. Prior to use, it is advisable to consult a healthcare professional if the child has a cough associated with excessive phlegm, a persistent or chronic cough such as that seen in asthma, or if the cough lasts longer than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache.

For dosing, the following guidelines apply:

  • For children under 4 years, consultation with a doctor is required before use.

  • For children aged 4 to under 6 years, the recommended dose is 2.5 mL every 6-8 hours.

  • For children aged 6 to under 12 years, the recommended dose is 5 mL every 6-8 hours.

  • For children aged 12 years and over, the recommended dose is 10 mL every 6-8 hours.

Geriatric Use

There is no specific information regarding the use of Children's Giltuss Honey DM Cough in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to consider the overall health status, potential comorbidities, and the possibility of polypharmacy in this population. Monitoring for adverse effects and therapeutic efficacy is recommended, as elderly patients may respond differently to medications compared to younger individuals. Additionally, dosage adjustments may be necessary based on individual patient assessments.

Pregnancy

There are no specific statements regarding the use of Giltuss Honey DM during pregnancy. The available prescribing information does not mention 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 Giltuss Honey DM during pregnancy.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

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 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 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

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

No postmarketing experience details are available in the provided text.

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 crucial to inform patients 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, the medication should not be administered for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their child's prescription contains an MAOI, they should be encouraged to consult with a doctor or pharmacist prior to using this product.

Patients should be instructed to stop using the medication and consult a doctor if their child experiences a cough that lasts longer than seven days, if the cough returns, or if it is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition.

Furthermore, healthcare providers should recommend that patients seek medical advice before using this medication if their 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). For optimal use, it is recommended to retain the carton, as it contains complete drug facts that may be necessary for reference.

Additional Clinical Information

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

Drug Information (PDF)

This file contains official product information for Childrens Giltuss Honey Dm Cough, 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 Dm Cough, 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.