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Childrens Multi Symptom Cold

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This product has been discontinued

Active ingredients
  • Guaifenesin 100 mg/5 mL
  • Dextromethorphan Hydrobromide 5 mg/5 mL
  • Phenylephrine Hydrochloride 2.5 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 2016
Label revision date
September 13, 2024
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
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 2016
Label revision date
September 13, 2024
Manufacturer
CVS Pharmacy
Registration number
M012
NDC root
59779-634
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 symptoms associated with the common cold in children aged 4 years and older. It contains three active ingredients: dextromethorphan HBr, which acts as a cough suppressant to temporarily relieve cough caused by throat and bronchial irritation; guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive; and phenylephrine HCl, a nasal decongestant that alleviates nasal congestion and stuffy nose.

This combination of ingredients works together to reduce coughing intensity, decrease the impulse to cough (which can help children sleep better), and relieve nasal congestion, providing comfort during cold symptoms. The formulation is alcohol-free and comes in a pleasant Very Berry flavor, making it easier for children to take.

Uses

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

You can use this medication to temporarily relieve coughs caused by minor throat and bronchial irritation, which can happen with the common cold or when you inhale irritants. It also helps reduce the intensity of your cough and the urge to cough, making it easier for your child to sleep. Additionally, it can relieve 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 not take more than 6 doses within a 24-hour period. To measure your dose accurately, always use 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 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

It's important to be cautious when using this product. You should not use it if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI), which are medications often prescribed for depression, certain 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, please consult a doctor or pharmacist.

While using this product, make sure to follow the directions carefully and do not exceed the recommended dosage. Misusing or abusing this product can lead to serious health issues, including dependence (a condition where the body becomes reliant on a substance). Always prioritize safety and seek guidance if you have any questions or concerns.

Side Effects

If your child experiences nervousness, dizziness, or sleeplessness, 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, you should also speak with a doctor if your child has any of the following health issues: heart disease, high blood pressure, thyroid disease, diabetes, or a cough that produces excessive mucus. It's especially important to consult a doctor if your child has a persistent or chronic cough, such as one associated with asthma.

Warnings and Precautions

It's important to be cautious when giving this medication to your child. Do not use it if your child is taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson’s disease, or for two weeks after stopping an MAOI. If you're unsure whether your child's medication contains an MAOI, please consult a doctor or pharmacist.

Before using this medication, talk to your doctor if your child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a cough with excessive mucus, or a chronic cough like asthma. If your child experiences nervousness, dizziness, or sleeplessness, or if symptoms do not improve within seven days, stop using the medication and contact your doctor. Additionally, if your child's cough lasts more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, seek medical advice as these may indicate a more serious issue. In case of an overdose, get emergency help or contact a Poison Control Center immediately 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 take overdosing seriously. If you notice any of these symptoms or have concerns about your health, don’t hesitate to reach out for help right away. Your safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with certain medications. Avoid using this medication if you or your child are taking a monoamine oxidase inhibitor (MAOI), which is a type of drug used for depression or other mental health conditions, or if it has been less than two weeks since stopping an MAOI. Always consult your doctor before using this medication if there are any existing health concerns, such as heart disease, high blood pressure, thyroid disease, diabetes, or a chronic cough like asthma.

Make sure to check that the packaging is intact; do not use it if the printed neckband is broken or missing. Keep this medication out of reach of children, and in case of an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your safety and the safety of your child are paramount, so always prioritize open communication with your healthcare provider.

Lactation Use

If you are breastfeeding, it's important to talk to your healthcare professional before using this product. There is a possibility that it can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Because of this uncertainty, it's best to exercise caution when considering its use while breastfeeding.

Pediatric Use

It's important to be cautious when giving medication to children. You should not use this medication if your child is currently taking a prescription monoamine oxidase inhibitor (MAOI) or has stopped taking one within the last two weeks. Before using it, consult your doctor if your child has any heart issues, high blood pressure, thyroid problems, diabetes, or a cough that produces a lot of mucus, or if they have a chronic cough like asthma.

For 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. It's crucial not to give this medication to children under 4 years old. Remember, do not exceed 6 doses in a 24-hour period, and always use the dosing cup provided to measure the medication accurately.

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 age-related dosage adjustments, safety concerns, or special precautions for elderly patients, you should still consult with a healthcare provider to ensure that this medication is appropriate for you or your loved one. Always discuss any existing health conditions or medications you are taking, as these factors can influence how well a treatment works and its safety.

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

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 be cautious when giving certain medications to children, especially if they are taking a prescription monoamine oxidase inhibitor (MAOI). MAOIs are specific drugs used to treat depression, psychiatric conditions, or Parkinson’s disease. You should not use this product in a child who is currently taking an MAOI or for at least two weeks after stopping it. If you're unsure whether your child's medication includes an MAOI, it's best to consult with a doctor or pharmacist before proceeding.

Always discuss any medications or treatments with your healthcare provider to ensure safety and avoid potential interactions. Your provider can help you understand the risks and make informed decisions about your child's health.

Storage and Handling

To ensure the best performance of your product, store it at room temperature between 20-25°C (68-77°F). It's important not to refrigerate it, as this can affect its effectiveness. Before use, check that the printed neckband is intact; do not use the product if it is broken or missing, as this could compromise safety.

When preparing to use the product, make sure to utilize the dosing cup provided for accurate measurement. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should take this medication orally and follow the dosing instructions carefully. It's important to keep it out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Make sure not to exceed the recommended dose, and if your symptoms do not improve within 7 days, or if you experience a fever, rash, or persistent headache, stop using the medication and consult your doctor. Always use the dosing cup provided to measure your dose, and do not use it with other products. Check that the neckband on the bottle is intact before use, and store the medication at room temperature (20-25°C or 68-77°F); do not refrigerate it.

FAQ

What is Children's Multi-Symptom Cold used for?

Children's Multi-Symptom Cold helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive. It temporarily relieves cough, nasal congestion, and stuffy nose due to colds.

What are the active ingredients in Children's Multi-Symptom Cold?

The active ingredients are Dextromethorphan HBr (5 mg), Guaifenesin (100 mg), and Phenylephrine HCl (2.5 mg).

What is the recommended dosage for children?

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 warnings for using this product?

Do not use in a child taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor if the child has heart disease, high blood pressure, thyroid disease, diabetes, or a persistent cough.

What should I do if my child experiences side effects?

Stop use and ask a doctor if your child becomes nervous, dizzy, or sleepless, or if symptoms do not improve within 7 days or occur with fever.

Is Children's Multi-Symptom Cold safe for nursing mothers?

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

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

Store at 20-25°C (68-77°F) and do not refrigerate. Ensure the printed neckband is intact.

What should I do in case of an overdose?

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

Packaging Info

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

Packaging configurations for Childrens Multi Symptom Cold.
Details

Drug Information (PDF)

This file contains official product information for Childrens Multi Symptom Cold, 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, containing the following active ingredients: Dextromethorphan HBr (5 mg), an effective cough suppressant; Guaifenesin (100 mg), an expectorant that aids in breaking up mucus; and Phenylephrine HCl (2.5 mg), a nasal decongestant. This product is alcohol-free and is available in a Very Berry flavor. It is indicated for the relief of symptoms associated with colds, including stuffy nose, cough, and chest congestion. The product is suitable for children aged 4 years and older and is provided in a dosage of 4 FL OZ (118 mL), with a dosage cup included for accurate measurement.

Uses and Indications

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

Additionally, this drug temporarily alleviates the intensity of coughing and reduces the impulse to cough, which may help children achieve restful sleep. It also provides relief from nasal congestion and a stuffy nose associated with colds.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. It is imperative to measure the dosage using only the dosing cup provided with the product. The dosing cup should not be used with any other products to ensure accurate measurement.

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. This product is not recommended for use in children under 4 years of age.

Healthcare professionals should advise caregivers to adhere strictly to these dosing guidelines or to follow any specific instructions provided by a physician.

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 prior to administration.

Additionally, exceeding the recommended dosage is contraindicated when using this product.

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 This product must not be administered to 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 used 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 Prior to use, it is advisable to consult a healthcare provider if the child has any of the following conditions:

  • Heart disease

  • High blood pressure

  • Thyroid disease

  • Diabetes

  • A cough that produces excessive phlegm (mucus)

  • A persistent or chronic cough, such as that associated with asthma.

Emergency Medical Help Instructions In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222 without delay.

Stop Taking and Call Your Doctor Instructions The use of this product should be discontinued and a healthcare provider should be contacted if the child experiences any of the following:

  • Nervousness, dizziness, or sleeplessness

  • Symptoms that do not improve within 7 days or are accompanied by fever

  • A cough that persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Side Effects

Patients should discontinue use and consult a healthcare professional if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they are accompanied by fever, it is advisable to seek medical advice. A cough that persists for more than 7 days, recurs, or occurs alongside fever, rash, or a persistent headache may indicate a serious underlying condition and warrants immediate medical attention.

Before using this product, it is important for patients to consult a healthcare provider if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or if they are experiencing a cough that is associated with excessive phlegm (mucus) or a persistent or chronic cough, such as that which occurs with asthma.

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, psychiatric disorders, emotional conditions, or Parkinson’s disease. Administration of this product should be avoided in children who are currently taking an MAOI or within 2 weeks of discontinuing such therapy.

Healthcare professionals are advised to confirm whether a child's prescription includes an MAOI prior to the initiation 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 Multi Symptom Cold (dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Childrens Multi Symptom Cold.
Details

Pediatric Use

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

Dosing recommendations for pediatric patients are as follows: for children aged 6 years to under 12 years, the dosage is 10 mL every 4 hours; for children aged 4 years to under 6 years, the dosage is 5 mL every 4 hours. This medication is not recommended for children under 4 years of age. It is important to not exceed 6 doses within a 24-hour period and to measure the dosage using only the dosing cup provided.

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 absence of specific data and the potential for variability in response among this population. Regular monitoring and assessment of therapeutic outcomes may be warranted to ensure safety and efficacy in elderly patients.

Pregnancy

Pregnant patients should be advised against the use of this medication in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease. The use of this medication is contraindicated during the period of MAOI therapy and for at least two weeks following the cessation of MAOI treatment due to potential adverse interactions.

Healthcare professionals should exercise caution and consult with a physician prior to recommending this medication to pregnant patients who have underlying health conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or chronic cough, including asthma.

It is imperative to ensure that the product is intact, as any broken or missing printed neckband may indicate compromised safety. Additionally, this medication should be stored out of reach of children to prevent accidental ingestion. 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.

Lactation

Nursing mothers should consult a healthcare professional 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with an overdose. Symptoms 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 and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details have been reported for SPL code 90375-7.

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 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 with a doctor or pharmacist prior to administering this product.

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

While using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should also encourage patients to consult a doctor before use if their child has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, a cough that produces excessive phlegm (mucus), or a persistent or chronic cough, such as that associated with asthma.

Storage and Handling

The product is supplied in a configuration that includes a dosing cup. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not permitted, as it may compromise the integrity of the product.

Healthcare professionals should ensure that the product is not used if the printed neckband is broken or missing, as this may indicate tampering or compromise in quality. Proper handling and storage conditions are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally. It is crucial to keep the product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222. Patients should adhere strictly to the recommended dosage and discontinue use if symptoms do not improve within 7 days, or if they are accompanied by fever. Additionally, if a cough persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache, patients should consult a healthcare professional, as these may indicate a serious condition.

Patients are advised to measure the medication using the dosing cup provided and not to use this cup with other products. The medication should not be used if the printed neckband is broken or missing. Proper storage conditions include maintaining a temperature of 20-25°C (68-77°F) and avoiding refrigeration.

Drug Information (PDF)

This file contains official product information for Childrens Multi Symptom 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 Multi Symptom 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.

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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.