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Dr Kids

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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 2025
Label revision date
October 2, 2025
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 2025
Label revision date
October 2, 2025
Manufacturer
CalmCo LLC
Registration number
M012
NDC root
73282-2523
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

This medication is designed to temporarily relieve cough caused by minor irritation in the bronchial tubes, often associated with a cold. It works by helping to loosen phlegm (mucus) and thin bronchial secretions, making your coughs more productive. This can help you feel more comfortable as your body fights off the cold.

Uses

If you're dealing with a cough caused by minor irritation in your bronchial tubes from a cold, this medication can provide temporary relief. It works by helping to loosen phlegm (mucus) and thin out bronchial secretions, making your coughs more productive. This means that you can clear out mucus more effectively, which can help you feel better as you recover.

Dosage and Administration

When using this medication, it's important to follow the instructions provided on the pouch to ensure safe and effective use. You should not exceed 6 doses within a 24-hour period. The amount you give your child depends on their age, so make sure to use the correct dose for their specific age group.

For children under 4 years old, it's best to consult a doctor before administering any doses. If your child is between 4 and 6 years old, you can give them 1 vial every 4 hours. For children aged 6 to under 12 years, the recommended dose is 1 to 2 vials every 4 hours. If your child is 12 years or older, they can take 2 to 4 vials every 4 hours. Remember to discard any unused portion of the medication after use to ensure safety.

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 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 administering 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

It's important to be aware of potential side effects when using this medication for your child. You should not use it if your child is currently taking a 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 giving this medication, consult a doctor if your child has a chronic cough, especially if it’s related to asthma or emphysema, or if the cough comes with excessive mucus. You should stop using the medication and seek medical advice if your child's cough lasts more than a week, keeps coming back, or is accompanied by fever, rash, or a persistent headache, as these could indicate a more serious issue. In case of an accidental overdose, it's crucial to get medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

You should not give this medication to your child if they are 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 contains an MAOI, please consult a doctor or pharmacist before using this product.

Before using this medication, it's important to check with a doctor if your child has a chronic cough, such as one caused by asthma or emphysema, or if the cough comes with a lot of mucus. If your child's cough lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or persistent headache, stop using the medication and contact your doctor, as these could be signs of a more serious issue.

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

Overdose

If you suspect an accidental 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 reach out for professional assistance. Your health and safety are the top priority.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety, dosage adjustments, 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 about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications or treatments during pregnancy.

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 to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to be cautious when giving medication to your child. 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 persistent cough, especially if it’s related to asthma or emphysema, or if the cough comes with a lot of mucus.

If your child's cough lasts more than a week, keeps coming back, or is accompanied by a fever, rash, or a persistent headache, stop using the medication and seek medical advice. Dosage varies by age: for children under 4, you should consult a doctor; for those aged 4 to under 6, give 1 vial every 4 hours; for ages 6 to under 12, give 1-2 vials every 4 hours; and for children 12 and older, 2-4 vials every 4 hours is appropriate. Always prioritize your child's health and safety by following these guidelines.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 determine the best course of action based on your kidney function and overall health.

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 should be used if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 68-77°F (20-25°C). This helps maintain its quality and performance.

When handling the product, be cautious not to use it if the pouch or vial is punctured, torn, or open, as this could compromise its safety. Always check the packaging before use to ensure it is intact.

Additional Information

No further information is available.

FAQ

What does this drug do?

This drug temporarily relieves cough due to minor bronchial irritation associated with a cold and helps loosen phlegm (mucus) to make coughs more productive.

What is the maximum dosage I can give?

Do not exceed 6 doses in a 24-hour period.

How should I determine the dosage for my child?

Use the dose that corresponds to your child’s age: Under 4 years: consult a doctor; 4 to under 6 years: 1 vial every 4 hours; 6 to under 12 years: 1-2 vials every 4 hours; 12 years and older: 2-4 vials every 4 hours.

Are there any contraindications for this drug?

Do not use if your child is taking a prescription monoamine oxidase inhibitor (MAOI) or for two weeks after stopping the MAOI drug.

What should I do if my child has a persistent cough?

Ask a doctor before use if your child has a persistent or chronic cough, or if the cough is accompanied by excessive phlegm (mucus).

When should I stop using this drug?

Stop use and ask a doctor if your child has a cough that persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.

What should I do in case of accidental overdose?

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

What are the storage instructions for this drug?

Store between 68-77°F (20-25°C) and do not use if the pouch or vial is punctured, torn, or open.

Packaging Info

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

Packaging configurations for Dr Kids.
Details

Drug Information (PDF)

This file contains official product information for Dr Kids, 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 temporary relief of cough due to minor bronchial irritation associated with a cold. It also aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby making coughs more productive.

Dosage and Administration

Healthcare professionals should adhere to the following dosage and administration guidelines. The maximum allowable dosage is six doses within a 24-hour period. It is imperative to follow the “Easy to Use” instructions provided on the pouch for proper administration.

Dosing is determined by the patient's age:

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

  • For patients aged 4 to under 6 years, administer 1 vial every 4 hours as needed.

  • For patients aged 6 to under 12 years, administer 1 to 2 vials every 4 hours as needed.

  • For patients aged 12 years and older, administer 2 to 4 vials every 4 hours as needed.

Any unused portion of the medication should be discarded appropriately after use.

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 two 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

It is imperative to adhere to the following warnings and precautions when administering this product to children.

Warnings This product must not be used 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, it should not be administered for a period of two weeks following the cessation of an MAOI. If there is uncertainty regarding whether a child’s prescription includes an MAOI, it is essential to consult a healthcare professional, such as a doctor or pharmacist, prior to administration.

General Precautions Before using this product, it is advisable to consult a healthcare provider if the child has a persistent or chronic cough, particularly if it is associated with conditions such as asthma or emphysema. Furthermore, caution is warranted if the cough is accompanied by excessive phlegm (mucus).

Stop Taking and Call Your Doctor Instructions Parents and caregivers should discontinue use and seek medical advice if the child experiences a cough that persists for more than one week, recurs frequently, 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 accidental overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center without delay at 1-800-222-1222. Prompt action is necessary to ensure the safety and well-being of the child.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product.

Serious adverse reactions may occur if the product is administered to 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, or Parkinson’s disease. It is crucial 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 should also seek medical advice before using this product if the child has a persistent or chronic cough, particularly if it is associated with conditions such as asthma or emphysema, or if the cough is accompanied by excessive phlegm (mucus).

If a child experiences a cough that persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, caregivers are advised to discontinue use and consult a doctor, as these symptoms may indicate a serious underlying condition.

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

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 Dr Kids (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dr Kids.
Details

Pediatric Use

Pediatric patients should not use this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping an MAOI. Prior to use, it is essential to consult a healthcare professional if the child has a persistent or chronic cough, such as that associated with asthma or emphysema, or if the cough is accompanied by excessive phlegm (mucus).

If a child's cough persists for more than one week, tends to recur, 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 advised.

  • For children aged 4 to under 6 years, the recommended dose is 1 vial every 4 hours.

  • For children aged 6 to under 12 years, the recommended dose is 1-2 vials every 4 hours.

  • For adolescents aged 12 years and older, the recommended dose is 2-4 vials every 4 hours.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy, including safety concerns, dosage modifications, or special precautions. Therefore, healthcare professionals are advised to exercise caution when prescribing this product to pregnant patients. The potential risks and benefits should be carefully considered, and alternative therapies may be explored in consultation with the patient. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any concerns with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there is no information available concerning 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 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 absence of detailed guidance 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 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 prescribing information.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay. The national hotline for the Poison Control Center is 1-800-222-1222, which provides 24/7 access to expert guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly mitigate potential adverse effects. It is essential for healthcare providers to be aware of the symptoms associated with overdose, although specific symptoms were not detailed in the provided information.

Management of an overdose may involve supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and assessment of the patient's condition are recommended to ensure appropriate interventions are implemented.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an accidental overdose. It is crucial for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in pouches and vials, with specific attention to the integrity of the packaging. It is essential to store the product at a temperature range of 68-77°F (20-25°C) to maintain its efficacy. Healthcare professionals should ensure that the pouches or vials are not punctured, torn, or open prior to use, as compromised packaging may affect the product's safety and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dr Kids, 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 Dr Kids, 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.