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Childrens Delsym

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Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 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 2013
Label revision date
June 28, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 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 2013
Label revision date
June 28, 2024
Manufacturer
RB Health (US) LLC
Registration number
M012
NDC root
63824-214
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Delsym® is a medication designed to help relieve cough and chest congestion in children aged 4 years and older. It contains two active ingredients: dextromethorphan HBr, which acts as a cough suppressant, and guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions. This combination works to make coughs more productive by clearing mucus from the bronchial passageways, providing temporary relief from coughing due to minor throat and bronchial irritation, such as that caused by the common cold or inhaled irritants.

In addition to easing coughs, Delsym® helps reduce the intensity of coughing and the urge to cough, which can be particularly helpful for your child at bedtime. The medication is available in a cherry flavor, making it more palatable for children.

Uses

This medication is designed to help you breathe easier by loosening phlegm (mucus) and thinning bronchial secretions. This action helps clear out bothersome mucus from your airways, making your coughs more productive.

You can use this medication to temporarily relieve coughs caused by minor throat and bronchial irritation, which can happen with the common cold or from inhaling irritants. It also helps reduce the intensity of your cough and can lessen the urge to cough, making it easier for your child to fall asleep.

Dosage and Administration

When using this product, it's important to follow the dosing instructions carefully. For children aged 6 to under 12 years, you should give them between 5 mL and 10 mL every 4 hours, but make sure not to exceed 6 doses in a 24-hour period. For younger children aged 4 to under 6 years, the dose is smaller, ranging from 2.5 mL to 5 mL every 4 hours.

If your child is under 4 years old, do not use this product. Always measure the dose using the dosing cup that comes with the product, and avoid using this cup for any other medications to ensure accurate dosing. If you have any questions or need further guidance, consult your doctor.

What to Avoid

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

It's also important to follow the dosing instructions carefully and not exceed the recommended amount. Misuse or taking more than directed can lead to serious health issues, including dependence (a condition where the body becomes reliant on a substance). Always prioritize safety and seek guidance if you have any questions.

Side Effects

You should be aware of some important safety information regarding this medication. It is not safe to use in children who are taking certain prescription medications called monoamine oxidase inhibitors (MAOIs), which are used for depression or other psychiatric conditions. If your child is on an MAOI or has stopped taking one within the last two weeks, consult a doctor or pharmacist before using this product.

If your child has a persistent cough, especially one associated with asthma or excessive mucus, it's best to talk to a doctor before use. You should also stop using the medication and seek medical advice if the cough lasts more than seven days, returns, or is accompanied by fever, rash, or a lasting headache, as these could indicate a more serious issue. In case of an overdose, it's crucial to get medical help or contact a Poison Control Center immediately.

Warnings and Precautions

You should not give this product to a child who is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression or certain other conditions, or for two weeks after stopping an MAOI. If you're unsure whether your child's medication includes an MAOI, please consult a doctor or pharmacist before use.

Before using this product, it's important to check with a doctor if your child has a persistent cough, especially if it’s related to asthma, or if the cough produces a lot of mucus. Always follow the dosing instructions carefully and do not exceed the recommended amount. If your child's cough lasts more than seven days, returns, or is accompanied by a fever, rash, or persistent headache, stop using the product and contact a doctor, as these may indicate a more serious issue.

Keep this product out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center.

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 assistance. Quick action can make a significant difference in ensuring your safety and well-being.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and make informed decisions that are best for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments during this important time.

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

It's important to be cautious when giving medication to children. You should not use this product if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), or if they have stopped taking it within the last two weeks. Before using this medication, consult your doctor if your child has a persistent cough, such as one caused by asthma, or if the cough is accompanied by excessive mucus.

When administering this product, make sure to follow the dosage guidelines carefully. For children aged 6 to under 12 years, the recommended dose is 5 mL to 10 mL every 4 hours. For those aged 4 to under 6 years, the dose is 2.5 mL to 5 mL every 4 hours. Do not use this medication for children under 4 years of age. Always use the product as directed, and if your child's cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache, stop use and consult a doctor.

Geriatric Use

When it comes to using Children's Delsym Cough Plus Chest Congestion DM for older adults, there is no specific information available in the drug insert. This means that if you are caring for an older adult, it's important to consult with a healthcare professional before using this medication. They can help determine if it's appropriate based on individual health needs and any other medications being taken. Always prioritize safety and seek guidance to ensure the best care for older adults.

Renal Impairment

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

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

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's crucial to be aware of potential interactions when considering medications for yourself or your child. For instance, if your child is taking a prescription monoamine oxidase inhibitor (MAOI)—a type of medication often used for depression or certain emotional conditions—this product should not be used. Additionally, it should not be given for at least two weeks after stopping an MAOI. If you're unsure whether your child's medication includes an MAOI, it's important to consult with a doctor or pharmacist before proceeding.

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

Storage and Handling

To ensure the best performance of your product, store it at room temperature between 20-25°C (68-77°F). It's important to avoid refrigerating the product, as this can affect its effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any additional safety instructions provided with the product to ensure safe and effective use.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is Delsym®?

Delsym® is a cough syrup for children that contains Dextromethorphan HBr (a cough suppressant) and Guaifenesin (an expectorant). It is available in a cherry flavor and is suitable for children aged 4 years and older.

How does Delsym® work?

Delsym® helps loosen phlegm (mucus) and thins bronchial secretions, making coughs more productive. It temporarily relieves cough due to minor throat and bronchial irritation.

What are the dosing instructions for Delsym®?

For children 6 to under 12 years, the dose is 5 mL - 10 mL every 4 hours. For children 4 to under 6 years, the dose is 2.5 mL - 5 mL every 4 hours. Do not use in children under 4 years of age.

Are there any contraindications for using Delsym®?

Do not use Delsym® in children taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor or pharmacist if unsure.

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

If your child's cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache, stop use and consult a doctor as these could be signs of a serious condition.

Is Delsym® safe to use during pregnancy or while nursing?

The product insert does not provide specific information regarding the use of Delsym® during pregnancy or while nursing. Consult your doctor for advice.

What should I do in case of an overdose?

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

How should Delsym® be stored?

Store Delsym® at 20-25°C (68-77°F) and do not refrigerate.

Packaging Info

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

Packaging configurations for Childrens Delsym.
Details

Drug Information (PDF)

This file contains official product information for Childrens Delsym, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Children's Delsym® COUGH +® Chest Congestion DM is indicated for the relief of cough and chest congestion in children aged 4 years and older. The formulation contains dextromethorphan HBr, a cough suppressant, and guaifenesin, an expectorant that thins and loosens mucus. The product is presented in a liquid dosage form with a cherry flavor and is packaged in a 4 fl oz (118 mL) bottle. The National Drug Code (NDC) for this product is 63824-214-64.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily alleviates the intensity of coughing and reduces 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

This product is intended for use in children and does not contain directions or complete warnings for adult use. Healthcare professionals should ensure that dosing does not exceed 6 doses within a 24-hour period.

Dosing should be measured exclusively with the dosing cup provided with the product. It is important to avoid using this dosing cup with any other products to ensure accurate measurement.

The recommended dosing is as follows, or as directed by a physician:

  • For children aged 6 to under 12 years: Administer 5 mL to 10 mL every 4 hours.

  • For children aged 4 to under 6 years: Administer 2.5 mL to 5 mL every 4 hours.

  • For children under 4 years of age: The product is not recommended for use.

Healthcare professionals should monitor the total number of doses administered to ensure compliance with the maximum dosing limit.

Contraindications

Use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a child's prescription medication, consultation with a healthcare professional is advised prior to administration of this product. Additionally, it is contraindicated to exceed the recommended dosage while using this product.

Warnings and Precautions

The use of this product is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past two weeks. MAOIs are commonly prescribed for conditions such as depression, certain psychiatric disorders, or Parkinson's disease. 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 administration.

Healthcare professionals should advise caregivers to seek medical guidance before using this product if the child presents with a persistent or chronic cough, particularly if it is associated with asthma, or if the cough is accompanied by excessive phlegm (mucus).

It is essential to adhere strictly to the recommended dosage; exceeding the directed amount can lead to adverse effects. Caregivers should be instructed to discontinue use and consult a healthcare provider if the child's cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a prolonged headache, as these symptoms may indicate a more serious underlying condition.

To ensure safety, this product must be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. It is contraindicated for use in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the discontinuation of such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a child's prescription, consultation with a healthcare professional is advised prior to administration.

Before using this product, it is recommended to consult a doctor if the child has a persistent or chronic cough, such as that which occurs with asthma, or if the cough is accompanied by excessive phlegm (mucus).

Patients should discontinue use and seek medical advice if the cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition.

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 product with monoamine oxidase inhibitors (MAOIs) is contraindicated. This includes prescription medications used for the treatment of depression, psychiatric or emotional conditions, and Parkinson's disease. Administration of this product in children who are currently taking an MAOI, or within 2 weeks of discontinuing an MAOI, may lead to serious adverse effects.

Healthcare professionals are advised to confirm whether a child's prescription medication contains an MAOI prior to prescribing this product. It is essential to consult with a doctor or pharmacist for clarification to ensure patient safety.

Packaging & NDC

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

Packaging configurations for Childrens Delsym.
Details

Pediatric Use

Pediatric patients should not use this product 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 persistent or chronic cough, such as that associated with asthma, or if the cough is accompanied by excessive phlegm (mucus).

Dosing recommendations are as follows: for children aged 6 to under 12 years, the dosage is 5 mL to 10 mL every 4 hours; for children aged 4 to under 6 years, the dosage is 2.5 mL to 5 mL every 4 hours. The product is not recommended for children under 4 years of age.

It is important to adhere to the directed dosage and to discontinue use and consult a healthcare professional if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a lasting headache.

Geriatric Use

There is no specific information regarding the use of Children's Delsym Cough Plus Chest Congestion DM in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to consider individual patient factors, including the presence of comorbidities and the potential for altered pharmacokinetics in this population. Monitoring for efficacy and adverse effects is recommended, as elderly patients may respond differently to treatment compared to younger populations.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when considering this product for women of childbearing potential and weigh the potential risks against the benefits. It is advisable to discuss any potential implications with patients who are pregnant or planning to become pregnant.

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 drug insert text 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 data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 be aware that they can vary based on the substance involved and the individual patient’s response.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on the severity of the overdose and the symptoms presented. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Reports of side effects have been received through voluntary submissions and surveillance programs. Patients and healthcare professionals are encouraged to report any adverse events associated with the use of the product to the designated contact number provided for this purpose.

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 product should not be used in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication. Patients should be encouraged to consult with a doctor or pharmacist if they are uncertain whether their child's prescription includes an MAOI.

Patients should be instructed to discontinue use and consult a doctor if a cough persists for more than seven days, returns, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious condition that requires medical attention.

When using this product, patients must be reminded not to exceed the recommended dosage. Additionally, healthcare providers should advise patients to consult a doctor before use if the child has a persistent or chronic cough, such as that associated with asthma, or if the cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F). Refrigeration is not permitted, as exposure to lower temperatures may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain product efficacy and safety.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Childrens Delsym, 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 Delsym, 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.