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Childrens Cold

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Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
  • Phenylephrine Hydrochloride 2.5 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
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 2024
Label revision date
June 10, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
  • Phenylephrine Hydrochloride 2.5 mg/5 mL
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
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 2024
Label revision date
June 10, 2025
Manufacturer
Walgreen Company
Registration number
M012
NDC root
0363-9057
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

Walgreens Children's Cold is a multi-symptom oral solution designed to help relieve common cold symptoms in children aged 4 to 11 years. This alcohol-free medication comes in a pleasant berry flavor and contains three active ingredients: dextromethorphan HBr, which acts as a cough suppressant; guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions; and phenylephrine HCl, a nasal decongestant that alleviates stuffy noses and nasal congestion.

This solution temporarily relieves cough due to minor throat and bronchial irritation, as well as the intensity of coughing, making it easier for your child to sleep. By helping to clear mucus from the bronchial passageways, it makes coughs more productive and provides comfort during cold symptoms.

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 also use this medication to temporarily relieve symptoms such as cough caused by minor throat and bronchial irritation, which can happen with the common cold or from inhaling irritants. It can help with a stuffy nose and nasal congestion due to a cold, reduce the intensity of your cough, and lessen the urge to cough, making it easier for your child to sleep.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure safety and effectiveness. You should never take more than the directed amount, and make sure not to exceed 6 doses within a 24-hour period. Always use the dose cup that comes with the medication for accurate measurement.

For children aged 6 to under 12 years, the recommended dose is 10 mL every 4 hours. If your child is between 4 and under 6 years old, the dose is 5 mL every 4 hours. However, if your child is under 4 years old, you should not use this medication. Always consult with a doctor if you have any questions or concerns about the appropriate dosage for your child.

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, or emotional conditions, or Parkinson’s disease. Additionally, you must 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, please consult a doctor or pharmacist.

Always follow the recommended dosage and never exceed it, as misuse can lead to serious health issues. Remember, taking medications responsibly is crucial for your child's safety and well-being.

Side Effects

If you experience nervousness, dizziness, or sleeplessness while using this medication, it's important to stop using it and consult your doctor. Additionally, if your symptoms do not improve within 7 days, or if they occur alongside a fever, you should seek medical advice. A cough that lasts more than 7 days, keeps coming back, or is accompanied by a fever, rash, or persistent headache may indicate a more serious condition, and you should contact your healthcare provider.

Warnings and Precautions

You should not give this medication to a child who is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of prescription drug 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 using this product, it's important to talk to a doctor if your child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a chronic cough (like asthma), or a cough with excessive mucus. If your child experiences an overdose, seek emergency medical help or contact a Poison Control Center immediately.

You should stop using this medication and call your doctor if your child experiences nervousness, dizziness, or trouble sleeping. Additionally, if symptoms do not improve within seven days, or if a cough lasts more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, these could indicate a more serious issue that needs medical attention.

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 not typical for you.

Don’t wait to see if symptoms improve; prompt action is essential. Always prioritize your safety and well-being by getting the help you need as soon as possible.

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, you should consult your doctor before using this product.

Use this product only if it is clearly necessary and after discussing it with your healthcare provider. There are no specific dosage modifications recommended for pregnant individuals, so it’s crucial to have a conversation with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with your healthcare professional before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Since the effects on infants who are breastfed have not been thoroughly studied, it's best to exercise caution. Your healthcare provider can help you weigh the benefits and risks to ensure the safety of both you and your baby.

Pediatric Use

It's important to be cautious when giving this medication to children. You should not use it if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks. Before using this medication, consult your doctor if your child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, or a persistent cough, especially if it’s related to asthma or involves a lot of mucus.

When it comes to dosing, children aged 6 to under 12 years can take 10 mL every 4 hours, while those aged 4 to under 6 years should take 5 mL every 4 hours. However, this medication is not recommended for children under 4 years old. Always follow your healthcare provider's guidance to ensure your child's safety.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about its effects or safety for this age group. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help assess any potential risks and determine the best approach based on individual health needs.

Always keep in mind that older adults may have different responses to medications due to factors like age-related changes in the body and existing health conditions. Therefore, discussing any concerns with a healthcare professional is essential to ensure safe and effective use.

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 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 crucial to be aware of potential interactions when considering medications for yourself or your child. Specifically, you should not use this medication if your child is currently taking a monoamine oxidase inhibitor (MAOI), which is a type of prescription drug often used for depression, certain psychiatric conditions, or Parkinson’s disease. Additionally, you should wait at least two weeks after stopping an MAOI before using this medication. If you're unsure whether your child's prescription 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, specifically at 25°C (77°F). It’s acceptable for the temperature to vary between 15°C and 30°C (59°F to 86°F) occasionally. Always check the end flap of the packaging for the expiration date and lot number, as this information is crucial for safety and effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Proper storage and careful handling will help you use the product safely and effectively.

Additional Information

If you are considering this medication, it is important to know that it is taken orally. Additionally, if you are concerned about the potential for medicine abuse, especially among teens, you can find helpful resources at www.StopMedicineAbuse.org. This site provides information on how to recognize and prevent medicine misuse.

Currently, there are no further details available regarding laboratory tests, patient counseling, or postmarketing experiences related to this medication.

FAQ

What is Walgreens Children's Cold?

Walgreens Children's Cold is a multi-symptom oral solution that is alcohol-free and comes in a berry flavor.

What are the active ingredients in Walgreens Children's Cold?

The active ingredients include Dextromethorphan HBr (a cough suppressant), Guaifenesin (an expectorant), and Phenylephrine HCl (a nasal decongestant).

What symptoms does Walgreens Children's Cold relieve?

It temporarily relieves cough due to minor throat and bronchial irritation, stuffy nose, nasal congestion due to a cold, and helps reduce the intensity of coughing.

What is the recommended dosage for children?

For children 6 to under 12 years, the dosage is 10 mL every 4 hours; for children 4 to under 6 years, it is 5 mL every 4 hours. Do not use in children under 4 years.

Are there any contraindications for using this product?

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

What should I do if my child experiences side effects?

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur, or if symptoms do not improve within 7 days.

Is Walgreens Children's Cold safe during pregnancy?

The safety of this product during pregnancy has not been established; consult a doctor before use if pregnant or planning to become pregnant.

Can nursing mothers use Walgreens Children's Cold?

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

How should Walgreens Children's Cold be stored?

Store at 25°C (77°F), with excursions permitted between 15°-30°C (59°-86°F).

Where can I learn more about medicine abuse?

You can learn about teen medicine abuse at www.StopMedicineAbuse.org.

Packaging Info

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

Packaging configurations for Childrens Cold.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Dextromethorphan HBr serves as a cough suppressant, while guaifenesin functions as an expectorant, and phenylephrine HCl acts as a nasal decongestant. This formulation is presented as an oral solution, specifically designed for children aged 4 to 11 years. The product is alcohol-free and features a berry flavor. Each bottle contains 4 fluid ounces (118 mL) of the solution.

Uses and Indications

This drug is indicated for the relief of cough and nasal congestion associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the expulsion of bothersome mucus and enhancing the productivity of coughs.

Additionally, this drug temporarily alleviates symptoms such as a stuffy nose and nasal congestion resulting from a cold. It is also effective in reducing the intensity of coughing and the impulse to cough, which can assist children in achieving restful sleep.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage and administration guidelines. The maximum dosage should not exceed the specified limits, and no more than six doses should be administered within a 24-hour period. It is essential to utilize only the dose cup provided with the medication for accurate measurement.

For children aged 6 to under 12 years, the recommended dosage is 10 mL every 4 hours as needed. For children aged 4 to under 6 years, the appropriate dosage is 5 mL every 4 hours. The medication is not recommended for use in children under 4 years of age.

Healthcare providers should ensure that patients understand these guidelines to promote safe and effective use of the medication.

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 such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and 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.

Additionally, exceeding the recommended dosage is contraindicated.

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 one within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson’s disease. 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.

Before administering this product, it is essential to consult a healthcare provider if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a persistent or chronic cough (such as that associated with asthma), or a cough accompanied by excessive phlegm (mucus). These conditions may necessitate special consideration or alternative treatment options.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should instruct caregivers to discontinue use and seek medical advice if the child experiences nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days, or if they are accompanied by fever, further evaluation is warranted. A cough that persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache may indicate a serious underlying condition and should prompt immediate medical consultation.

Side Effects

Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, medical advice should be sought. A persistent cough lasting more than 7 days, recurrent cough, or cough associated with fever, rash, or a persistent headache may indicate a serious underlying condition and warrants immediate medical evaluation.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated in pediatric patients. MAOIs are typically prescribed for the treatment of depression, certain psychiatric conditions, or Parkinson’s disease. Administration of this product should not occur in children who are currently taking an MAOI or within 2 weeks following the discontinuation of such therapy.

Healthcare professionals are advised to confirm whether a child's prescription includes an MAOI prior to the administration of this product. If there is any uncertainty regarding the presence of an MAOI in the child's medication regimen, consultation with a physician or pharmacist is strongly recommended to ensure patient safety.

Packaging & NDC

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

Packaging configurations for Childrens Cold.
Details

Pediatric Use

Pediatric patients should not be administered this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. Prior to use, it is essential to consult a healthcare professional if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, persistent or chronic cough (such as that associated with asthma), or cough accompanied by excessive phlegm (mucus).

Dosing recommendations for pediatric patients are as follows: for children aged 6 to under 12 years, the recommended dose is 10 mL every 4 hours; for children aged 4 to under 6 years, the dose is 5 mL every 4 hours. This medication is not recommended for children under 4 years of age.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor this population closely for any potential adverse effects or changes in efficacy, as age-related physiological changes may influence drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and concurrent medications that are common in geriatric patients, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider 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. No specific dosage modifications are provided for this population. It is recommended that this product be used only if clearly needed and after a thorough discussion with a healthcare provider regarding the potential risks and benefits.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk. 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 individuals 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 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 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 assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of the symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

In summary, timely medical intervention and thorough assessment are critical components in the management of overdose situations.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. 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. If patients are uncertain whether their child's prescription includes an MAOI, they should be encouraged to consult a doctor or pharmacist prior to administering this product.

Patients should be instructed to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or if they occur alongside a fever, or if a cough persists for more than seven days, recurs, or is accompanied by a fever, rash, or persistent headache, they should seek medical advice, as these may indicate a serious condition.

It is important to emphasize that patients must not exceed the recommended dosage while using this product. Furthermore, healthcare providers should recommend that patients consult a doctor before use if the child has any of the following conditions: diabetes, heart disease, thyroid disease, high blood pressure, a persistent or chronic cough such as that associated with asthma, or a cough that produces excessive phlegm (mucus).

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F).

Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure proper inventory management and product safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens Cold, 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 Cold, 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

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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.