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Childrens Multi Symptom Cold Very Berry

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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
Liquid
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
January 17, 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
Liquid
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
January 17, 2025
Manufacturer
CVS
Registration number
M012
NDC root
51316-815
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Children's Multi-Symptom Cold is a medication designed to help relieve various symptoms associated with colds in children aged 4 years and older. It 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 nasal congestion and stuffy nose.

This product temporarily relieves cough caused by minor throat and bronchial irritation, reduces the intensity of coughing, and helps suppress the urge to cough, making it easier for your child to sleep. Additionally, it helps clear nasal congestion, providing comfort during cold symptoms. The medication is alcohol-free and comes in a pleasant Very Berry flavor, making it more appealing for children.

Uses

This medication is designed to help you manage coughs and congestion effectively. It works by loosening phlegm (mucus) and thinning bronchial secretions, which helps drain your bronchial tubes and makes your coughs more productive.

You can use this medication to temporarily relieve cough caused by minor throat and bronchial irritation, which can happen with a cold or from inhaling irritants. It also helps reduce the intensity of your cough and the urge to cough, making it easier for you or your child to get to sleep. Additionally, it can alleviate nasal congestion and a stuffy nose associated with colds.

Dosage and Administration

When using this medication, it's important to follow the dosing instructions carefully to ensure safety and effectiveness. You should never take more than 6 doses within a 24-hour period. To measure your dose accurately, use only the dosing cup that comes with the medication, and avoid using it with any other products to prevent confusion.

For children, the dosage varies by age. If your child is between 6 years and under 12 years, they should take 10 mL (milliliters) every 4 hours. For children aged 4 years to under 6 years, the dose is 5 mL every 4 hours. However, if your child is under 4 years old, this medication should not be used. Always consult with a doctor if you have any questions or concerns about the appropriate dosage for your child.

What to Avoid

You should avoid using this product in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric, or emotional conditions, or Parkinson's disease. Additionally, do not give this product to a child for at least two weeks after stopping an MAOI. If you're unsure whether your child's medication contains an MAOI, please consult a doctor or pharmacist.

It's also important to follow the dosing instructions carefully and not to exceed the recommended amount. Always prioritize safety and seek guidance if you have any questions or concerns about the medication.

Side Effects

If your child experiences nervousness, dizziness, or trouble sleeping, it's important to stop using the medication and consult a doctor. Additionally, if symptoms do not improve within 7 days, or if a cough lasts more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, these could indicate a more serious condition that requires medical attention.

Before using this medication, please talk to a doctor if your child has any of the following: heart disease, high blood pressure, thyroid disease, diabetes, or a chronic cough, such as one associated with asthma, or a cough that produces excessive mucus.

Warnings and Precautions

It's important to be cautious when using this medication, especially for children. Do not give it to a child who is currently taking a prescription 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.

If you suspect an overdose, seek medical help immediately or contact a Poison Control Center. You should also stop using the medication and call your doctor if your child experiences nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days, or if they occur with a fever, or if a cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, these could indicate a more serious condition that requires medical attention.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely action can make a significant difference.

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. Before using it, you should consult your doctor to discuss any potential risks. There may be risks to your fetus, so this product should only be used if it is clearly needed and prescribed by a healthcare provider. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your baby.

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

You should avoid using this medication in children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking one within the last two weeks. Before giving this product to your child, consult a doctor if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a persistent cough (like asthma), or a cough with excessive mucus.

When using this medication, make sure to follow the dosing instructions carefully. Do not exceed six doses in a 24-hour period, and always use the dosing cup provided. For children aged 6 to under 12 years, the recommended dose is 10 mL every four hours, while for those aged 4 to under 6 years, it is 5 mL every four hours. This product is not recommended for children under 4 years old. If your child experiences nervousness, dizziness, or sleeplessness, or if their symptoms do not improve within seven days, contact a doctor. Additionally, if a cough lasts more than seven days or is accompanied by fever, rash, or a persistent headache, seek medical advice.

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. Your healthcare provider can guide you on the appropriate dosage and monitor for any side effects.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because renal impairment (reduced kidney function) can affect how your body processes certain drugs. To ensure your safety, your healthcare provider will monitor your creatinine clearance (a test that measures how well your kidneys are filtering waste) regularly.

Additionally, regular renal function tests are essential to keep track of your kidney health. If you have significant renal impairment, you will require special monitoring to manage your treatment effectively. Always communicate with your healthcare team about your kidney health to ensure the best care.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's crucial to talk to your healthcare provider about any medications you are taking, especially if you or your child is on a prescription monoamine oxidase inhibitor (MAOI). MAOIs are used to treat certain mental health conditions and can interact negatively with other drugs. If you or your child has been prescribed an MAOI, you should not use this medication while on the MAOI or for at least two weeks after stopping it.

While there are no specific laboratory test interactions noted, discussing all your medications and any tests you may need with your healthcare provider ensures your safety and the effectiveness of your treatment. Always keep your healthcare team informed about your current medications to avoid any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 15-30 ºC (59-86 ºF). It's important not to refrigerate the product, as this can affect its effectiveness.

When using the product, a dosing cup is provided to help you measure the correct amount safely. Always handle the product with care to maintain its quality and effectiveness.

Additional Information

No further information is available.

FAQ

What is Children's Multi-Symptom Cold?

Children's Multi-Symptom Cold is a medication that contains Dextromethorphan HBr (cough suppressant), Guaifenesin (expectorant), and Phenylephrine HCl (nasal decongestant). It is alcohol-free and suitable for children aged 4 years and older.

How does Children's Multi-Symptom Cold work?

It helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive. It temporarily relieves cough, nasal congestion, and stuffy nose.

What is the recommended dosage for Children's Multi-Symptom Cold?

For children 6 years to under 12 years, the dosage is 10 mL every 4 hours. For children 4 years 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 your child gets nervous, dizzy, or sleepless, or if symptoms do not improve within 7 days or occur with fever.

Is it safe to use Children's Multi-Symptom Cold 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.

How should I store Children's Multi-Symptom Cold?

Store between 15-30 ºC (59-86 ºF) and do not refrigerate. Use the dosing cup provided for measurement.

Packaging Info

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

Packaging configurations for Childrens Multi Symptom Cold Very Berry.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

CVS Health® Children's Multi-Symptom Cold is a liquid formulation designed for pediatric use, indicated for the relief of multiple cold symptoms. Each 4 fluid ounce (118 mL) bottle contains the following active ingredients: Dextromethorphan HBr (5 mg), serving as a cough suppressant; Guaifenesin, an expectorant; and Phenylephrine HCl, a nasal decongestant. This product effectively relieves nasal and chest congestion, soothes cough, and thins and loosens mucus. It is alcohol-free and suitable for children aged 4 years and older. The formulation is presented in a Very Berry flavor and includes a dosage cup for accurate administration. The National Drug Code (NDC) for this product is 51316-815-03.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to colds or inhaled irritants. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating drainage of the bronchial tubes and enhancing the productivity of coughs.

Additionally, this drug temporarily alleviates the intensity of coughing and reduces the impulse to cough, which may aid in promoting sleep in pediatric patients. It also provides relief from nasal congestion and a stuffy nose associated with colds.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the following dosage guidelines. The maximum allowable dosage is 6 doses within any 24-hour period. It is imperative to measure the medication using only the dosing cup provided with the product; the dosing cup should not be used with any other products to ensure accurate dosing.

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

Healthcare professionals should ensure that caregivers understand these instructions 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 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, consultation with a healthcare professional is advised prior to administration of this product. Additionally, the product should not be used in excess of the directed dosage.

Warnings and Precautions

The use of this product requires careful consideration of specific precautions to ensure the safety and well-being of pediatric patients.

General Precautions This product is contraindicated 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 2 weeks following the discontinuation of an MAOI. Healthcare professionals should advise caregivers to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in the child's prescription medication.

Emergency Medical Help Instructions In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay.

Stop Taking and Call Your Doctor Instructions Caregivers should be instructed to discontinue use and consult a healthcare provider if the child experiences symptoms such as nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within 7 days, or if they are accompanied by fever, it is essential to seek medical advice. Persistent cough lasting more than 7 days, or a cough that recurs or is associated with fever, rash, or a persistent headache, may indicate a serious underlying condition and warrants prompt medical evaluation.

Side Effects

Patients may experience a range of adverse reactions, although no specific side effects have been identified in clinical trials or postmarketing experiences. It is important for caregivers to monitor children for certain symptoms and to seek medical advice under specific circumstances.

Caregivers should stop use and consult a doctor if the child exhibits signs of nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they occur alongside fever, it is advisable to seek medical attention. A cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache may indicate a serious illness and warrants immediate medical evaluation.

Before administering this product, caregivers should consult a doctor if the child has a history of heart disease, high blood pressure, thyroid disease, diabetes, or persistent or chronic cough, such as that associated with asthma. Furthermore, a cough that is accompanied by excessive phlegm (mucus) should also prompt a discussion with a healthcare professional.

No additional adverse reactions have been reported.

Drug Interactions

The use of this medication is contraindicated in pediatric patients who are concurrently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, this medication should not be administered for a period of two weeks following the discontinuation of an MAOI.

No specific interactions with laboratory tests have been identified in the available data.

Packaging & NDC

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

Packaging configurations for Childrens Multi Symptom Cold Very Berry.
Details

Pediatric Use

Pediatric patients aged 4 years and older may use this product, but it is contraindicated in children under 4 years of age. For children aged 6 years to under 12 years, the recommended dosage is 10 mL every 4 hours, while for those aged 4 years to under 6 years, the dosage is 5 mL every 4 hours. It is crucial to measure the dose using the dosing cup provided and not to exceed 6 doses in any 24-hour period.

Healthcare professionals should advise caregivers to consult a doctor before use if the child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, persistent or chronic cough (such as occurs with asthma), or cough accompanied by excessive phlegm.

While using this product, caregivers should ensure that the child does not take more than the directed dosage. They should also be instructed to stop use and consult a doctor if the child experiences nervousness, dizziness, or sleeplessness, if symptoms do not improve within 7 days, or if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache.

It is important to note that this product should not be used in children who are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after discontinuing an MAOI.

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. There may be potential risks to the fetus; therefore, use should be avoided unless clearly needed and prescribed by a healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing 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 may necessitate dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function. Regular renal function tests should be performed to assess kidney health, and special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with altered pharmacokinetics.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information 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. Regular monitoring of liver function may be warranted in these patients to ensure safety and therapeutic effectiveness.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from excessive dosing. Symptoms of overdosage can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdoses specific to the substance in question.

Documentation of the incident, including the amount ingested and the time of ingestion, is crucial for effective treatment and follow-up care.

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 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 there is uncertainty regarding whether a child's prescription includes an MAOI, patients should be encouraged to consult with a doctor or pharmacist prior to administering this product.

Patients should be instructed to discontinue use and consult a doctor if the child experiences nervousness, dizziness, or sleeplessness. Additionally, they should be made aware that if symptoms do not improve within seven days or are accompanied by fever, they should seek medical advice. It is also important to inform patients that if a cough persists for more than seven days, recurs, or occurs with fever, rash, or a persistent headache, these may indicate a serious illness, and they should contact a healthcare professional.

While using this product, patients must be reminded not to exceed the recommended dosage. Furthermore, healthcare providers should advise patients to consult a doctor before use if the child has a history of heart disease, high blood pressure, thyroid disease, diabetes, or 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 with a dosing cup included for accurate measurement. It should be stored at a temperature range of 15-30 ºC (59-86 ºF). Refrigeration is not recommended, and the product must be kept away from extreme temperatures to ensure its integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Childrens Multi Symptom Cold Very Berry, 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 Multi Symptom Cold Very Berry, 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.