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Drkids Childrens Cough and Chest Congestion Dm

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This product has been discontinued

Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
Other brand names
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 2023
Label revision date
May 24, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
Other brand names
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 2023
Label revision date
May 24, 2024
Manufacturer
CalmCo LLC
Registration number
M012
NDC root
73282-0013
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

This medication is designed to temporarily relieve cough caused by minor irritation in the throat and bronchial tubes, which can happen during a cold. It works by helping to loosen phlegm (mucus) and thin bronchial secretions, making it easier for you to cough up mucus and clear your airways. This can help you feel more comfortable when you're dealing with a cough associated with a cold.

Uses

If you're dealing with a cough caused by minor irritation in your throat or bronchial tubes, especially from a cold, this medication can provide temporary relief. It works by soothing your throat and reducing the urge to cough.

Additionally, this medication helps to loosen phlegm (mucus) and thin out bronchial secretions. This makes your cough more productive, allowing you to clear out mucus more effectively.

Dosage and Administration

When using this medication, it's important to follow the dosing guidelines carefully. For children under 4 years old, you should consult a doctor before administering any doses. If your child is between 4 and 5 years old, give them 1 Single-Use Vial (which contains 5 mL of liquid) every 4 hours. For children aged 6 to 11 years, you can give 1 to 2 Single-Use Vials every 4 hours, depending on their needs.

For adults and children aged 12 years and older, the recommended dose is 2 to 4 Single-Use Vials every 4 hours. Remember to empty all the liquid from each vial when you dose. It's also crucial not to exceed 6 doses in any 24-hour period, so keep track of how many doses you've given throughout the day. Always refer to the instructions on how to open and use the vials, which can be found on the side panel of the packaging.

What to Avoid

It's important to be cautious when considering this medication for your child. You should not use it if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which are specific medications used for depression, psychiatric conditions, or Parkinson’s disease. Additionally, you should wait at least two weeks after stopping an MAOI before giving this product. If you're unsure whether your child's prescription includes an MAOI, please consult with a doctor or pharmacist for clarification. Your child's safety is the top priority, so don't hesitate to ask for guidance.

Side Effects

You should be aware of some important warnings regarding this medication. It should not be used if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication 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 using this product, consult a doctor if your child has a persistent or chronic cough, especially if it is associated with asthma or excessive mucus. You should stop using the medication and seek medical advice if the cough lasts more than 7 days, comes back frequently, or is accompanied by fever, rash, or a persistent headache, as these could indicate a more serious health issue. Always keep this medication out of reach of children, and in case of an overdose, contact a medical professional or Poison Control Center immediately at 1-800-222-1222.

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, certain psychiatric conditions, or Parkinson’s disease. Additionally, do not use it for two weeks after stopping an MAOI. If you are unsure whether your child's medication contains an MAOI, please consult a doctor or pharmacist.

Before giving this product, ask your doctor if your child has a persistent or chronic cough, especially if it is related to asthma or if it comes with excessive mucus. If your child's cough lasts more than 7 days, keeps coming back, or is accompanied by fever, rash, or a persistent headache, stop using the product and contact your doctor, as these could be signs of a more serious issue.

In the event of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Always err on the side of caution—if you notice any concerning symptoms or if you’re unsure, don’t hesitate to get help right away. 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 the safety of this product during pregnancy has not been established. There may be potential risks to your fetus, and further studies are needed to fully understand these risks. Therefore, it is crucial to consult your doctor before using this product.

Currently, there are no specific dosage modifications recommended for pregnant individuals, so it's best to seek guidance from a healthcare professional regarding its use. Your health and the health of your baby are the top priority, so always discuss any medications or products with your doctor.

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 concerns with your healthcare provider.

Pediatric Use

If your child is 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 persistent cough, especially if it’s related to asthma or accompanied by excessive mucus. If your child's cough lasts more than seven days, keeps coming back, or is accompanied by a fever, rash, or a 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 5 years, the recommended dose is one 5 mL vial every four hours, while children aged 6 to 11 years can take one to two vials every four hours. Remember, do not exceed six doses in a 24-hour period.

Geriatric Use

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

Renal Impairment

If you have kidney problems, it's important to know that 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 should be used 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 you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the provided drug insert does not include specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established 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 tailored to your needs.

Drug Interactions

It's important to be cautious when giving medications to your child, especially if they are taking certain prescription drugs. Specifically, you should avoid using this product if your child is currently on a monoamine oxidase inhibitor (MAOI), which is a type of medication often prescribed for depression, psychiatric conditions, or Parkinson’s disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this product. If you're unsure whether your child's medication includes an MAOI, it's best to consult with a doctor or pharmacist for guidance.

Always discuss any medications or treatments with your healthcare provider to ensure safety and avoid potential interactions. Your child's health is a priority, and getting professional advice can help you make informed decisions.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25ºC (68-77ºF). This helps maintain its effectiveness. Always check the packaging before use: if the top flap of the carton is open or if any vials are open or broken, do not use the product, as this indicates it may have been tampered with or compromised.

Handling the product with care is essential. Make sure to keep it in a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the purpose of this drug?

This drug temporarily relieves cough due to minor throat and bronchial irritation, such as that which may occur with a cold, and helps loosen phlegm (mucus) to make cough more productive.

What is the recommended dosage for children under 4 years?

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

How often can I give this drug to children aged 4 to 5 years?

Children aged 4 to 5 years can take 1 Single-Use Vial (5 mL) every 4 hours.

What is the maximum number of doses I can give in 24 hours?

You should not give more than 6 doses in any 24-hour period.

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

You should stop use and ask a doctor if the cough lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache.

Can I use this drug if my child is taking a monoamine oxidase inhibitor (MAOI)?

No, do not use this drug if your child is taking a prescription MAOI or for two weeks after stopping the MAOI.

Is this drug safe to use during pregnancy?

The safety of this product during pregnancy has not been established, and you should consult a doctor if pregnant or planning to become pregnant.

What should nursing mothers do before using this product?

Nursing mothers should consult a doctor before using this product due to the potential for excretion in breast milk.

How should I store this drug?

Store the drug at 20-25ºC (68-77ºF) and do not use if the top flap of the carton is open or if any vials are open or broken.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Packaging Info

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

Packaging configurations for Drkids Childrens Cough and Chest Congestion Dm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description section.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating a more productive cough.

Limitations of Use: This medication is intended for symptomatic relief and does not address the underlying causes of cough or cold symptoms.

Dosage and Administration

Healthcare professionals are advised to adhere to the following dosage and administration guidelines.

For patients under 4 years of age, consultation with a physician is required prior to administration.

For children aged 4 to 5 years, the recommended dosage is 1 Single-Use Vial (5 mL) every 4 hours.

For children aged 6 to 11 years, the dosage may range from 1 to 2 Single-Use Vials (5 mL each) every 4 hours, depending on the clinical situation and patient response.

For adults and children aged 12 years and older, the dosage is 2 to 4 Single-Use Vials (5 mL each) every 4 hours.

It is imperative that no more than 6 doses are administered within a 24-hour period. Each Single-Use Vial must be completely emptied during dosing. Healthcare professionals should follow the instructions provided under "How to Open and Use" located on the side panel of the packaging to ensure proper administration.

Contraindications

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 depression, psychiatric or emotional conditions, and Parkinson’s disease. Due to the potential for serious interactions, it is essential to consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

Warnings and Precautions

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

Warnings The use of this product is contraindicated in children who are concurrently taking prescription monoamine oxidase inhibitors (MAOIs), which are 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. 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.

General Precautions Before administering this product, it is essential to consult a healthcare provider if the child has a persistent or chronic cough, particularly if it is associated with asthma or if the cough is accompanied by excessive phlegm (mucus).

Stop Taking and Call Your Doctor Instructions Caregivers should be instructed to discontinue use and seek medical advice if the child's cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

Get Emergency Medical Help Instructions In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt action is crucial in managing potential overdose situations effectively.

Side Effects

Patients should be aware of the following warnings and precautions associated with the use of this product. It is contraindicated in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks following the discontinuation of such medication. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. If there is uncertainty regarding whether a child’s prescription includes an MAOI, it is essential to consult a healthcare professional before administering this product.

Before use, it is advisable 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 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

It is crucial to keep this product out of reach of children to prevent accidental ingestion or misuse.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, certain psychiatric conditions, or Parkinson’s disease. It is essential to avoid administering this product to a child who is currently taking an MAOI or has taken one within the past two weeks.

If there is uncertainty regarding whether a child's prescription medication contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to the administration of this product. This precaution is necessary to prevent potential adverse effects associated with the interaction between this product and MAOIs.

Packaging & NDC

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

Packaging configurations for Drkids Childrens Cough and Chest Congestion Dm.
Details

Pediatric Use

Pediatric patients should not use this medication if they are taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after discontinuing 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).

If the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, the use of this medication should be discontinued, and a doctor should be consulted.

Dosing recommendations for pediatric patients are as follows:

  • For children under 4 years of age, consultation with a doctor is required.

  • For children aged 4 to 5 years, the recommended dose is 1 Single-Use Vial (5 mL) every 4 hours.

  • For children aged 6 to 11 years, the recommended dose is 1 to 2 Single-Use Vials (5 mL each) every 4 hours.

It is important not to exceed 6 doses in any 24-hour period.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the individual health status and potential comorbidities that may influence treatment outcomes. Regular monitoring may be warranted to ensure safety and efficacy in this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use, as there may be potential risks to the fetus. Further studies are needed to determine the safety profile of this product in pregnant individuals. Currently, no specific dosage modifications for pregnant individuals are provided; therefore, it is essential to seek guidance from a healthcare professional regarding use during pregnancy.

Lactation

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

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 there is no available data to guide dosing or monitoring in this population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there is no information available regarding 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.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical support can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care, monitoring of vital signs, and symptomatic treatment as necessary. It is essential for healthcare professionals to remain vigilant and act swiftly to mitigate potential complications associated with overdose.

Nonclinical Toxicology

No teratogenic effects were reported in the studies conducted. Additionally, there was no increase in fetal malformations observed, indicating a lack of non-teratogenic effects. Information regarding nonclinical toxicology and animal pharmacology and toxicology was not provided in the insert.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to inform patients that this product should not be used if their child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has taken one within the last two weeks. Patients should be encouraged to consult with a doctor or pharmacist if they are uncertain whether their child's prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if their child's cough 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 more serious underlying condition. Additionally, healthcare providers should recommend that patients consult a doctor before using this product if their 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 a tamper-evident carton. It is essential to inspect the carton before use; do not use if the top flap of the carton is open or if any vials are open or broken.

For optimal storage, the product should be maintained at a temperature range of 20-25ºC (68-77ºF). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Drkids Childrens Cough and Chest Congestion Dm, 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 Drkids Childrens Cough and Chest Congestion Dm, 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

Last AI update:

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.